GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta-based biotechnology company, today reported successful early results from two ongoing AIDS prevention Phase I human vaccine trials. Results from the first low dose trial indicate a good safety profile as well as positive immune responses in human volunteers receiving 1/10th dose of GeoVax's AIDS vaccine. Results from a second larger full dose trial also indicate a good safety profile in participants. The GeoVax vaccines being tested are designed to prevent the development of Acquired Immunodeficiency Disease ("AIDS") caused by the virus known as HIV-1 by vaccinating individuals prior to infection with the AIDS virus.
Early results from GeoVax's preventative HIV/AIDS vaccine human trials:
-- Demonstrate a very acceptable safety profile in an ongoing 1/10th dose trial begun in April, 2006
-- Indicate that as low as 1/10th of a full dose of GeoVax's HIV/AIDS vaccine stimulates potentially protective anti-HIV-1 immune responses in the majority of vaccine recipients
-- Suggest an acceptable safety profile in an ongoing full dose trial begun Sept 2006
-- Suggest that a full dose of the vaccine will stimulate an even better immune response in recipients participating in the full dose trial; data is expected later in 2007
-- Support accelerated planning for a large Phase II human trial including more than 300 participants across North and South America and the Caribbean and with an earlier start date than originally anticipated
The 1/10th dose trial, begun April, 2006, is evaluating GeoVax's AIDS vaccines primarily for their safety and potential efficacy as a preventative vaccine administered to people prior to infection with the HIV-1 virus, thus preventing the development of AIDS. A positive human immune response to the vaccine is indicated by the presence of antibodies and T cells (white blood cells) that recognize and control viral infections.
"We are very encouraged by the positive immune responses in six human volunteers receiving only 1/10th of a dose of vaccine," said Dr. Harriet Robinson, GeoVax's Chief Scientific Advisor and developer of the AIDS vaccine. "This trial group consisted of 11 volunteers, with two individuals that received no vaccine as part of the blinded study. In this group, only 1/10th of a dose of GeoVax's DNA vaccine was administered at week 0 and at week 8 to prime the immune response. The immune response was then boosted by administration of 1/10th of a dose of GeoVax's MVA vaccine at week 16 and again at week 24."
The vaccine response was determined in tests conducted on human blood samples collected after vaccination. These assays were conducted at the Emory University Vaccine Center under the guidance of Dr. Harriet Robinson.
Based on the excellent safety demonstrated in the 1/10th dose vaccine trial, a full dose human trial started in September, 2006. Thus far, the trial has enrolled 36 volunteers. Thirty of the volunteers received the vaccine, while six control subjects received a placebo (no vaccine). The full dose of AIDS vaccine approximates the dose size that protected 22 of 23 (96%) of non- human primates for more than 3 1/2 years against development of AIDS. The immune response generated in the majority of volunteers receiving 1/10th dose of GeoVax's vaccines suggests that the vaccines, when administered at full dose, may elicit outstanding responses.
More information will be released on the full dose trial when available later in 2007. GeoVax's AIDS vaccines contain only part of the HIV-1 virus and cannot cause AIDS. These vaccines contain the three major genes of the HIV- 1/AIDS virus and mimic actual virus infections by producing non-infectious HIV-like particles in vaccinated individuals.
The human trials, utilizing GeoVax's AIDS vaccines, are being conducted by the HIV Vaccine Trials Network (HVTN), based in Seattle, Washington. The HVTN, which is funded and supported by the National Institutes of Health, is the largest worldwide clinical trials program devoted to the development and testing of HIV/AIDS vaccines. Preclinical work enabling development of the clinical evaluation of GeoVax's DNA and MVA vaccines was also funded and supported by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
GeoVax Labs, Inc.
http://www.geovax.com/
March 7, 2007
Reports, Programming Launched Ahead Of Annual National Black HIV/AIDS Awareness Day
Wednesday marks the seventh annual National Black HIV/AIDS Awareness Day, which is sponsored by the Community Capacity Building Coalition, a consortium of national minority-focused groups supported by CDC's Division of HIV/AIDS Prevention. The CCBC includes Concerned Black Men of Philadelphia, the Health Watch Information and Promotion Service, the Jackson State University-Mississippi Urban Research Center, the National Black Alcoholism and Addictions Council and the National Black Leadership Commission on AIDS. The goal of National Black HIV/AIDS Awareness Day is to motivate black people to "get tested" for HIV, "get educated" about how the virus is transmitted, "get involved" in community HIV/AIDS programs and "get treated" if they are HIV-positive (NBHAAD Web site, 2/2). Ahead of NBHAAD, CDC's Morbidity and Mortality Weekly Report released a study about HIV among blacks in Florida, and BET announced it will launch three HIV/AIDS-themes programs. Summaries of those efforts appear below.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
- "HIV/AIDS Diagnoses Among Blacks -- Florida, 1999-2004," MMWR: According to an analysis from the Florida Department of Health released in the Feb. 2 issue of MMWR, new HIV cases among blacks residing in Florida has decreased by an average of more than 8% annually among men and more than 10% annually among women from 1999 to 2004, the AP/Gainesville Sun reports (Royse, AP/Gainesville Sun, 2/1). HIV incidence among blacks nationwide has decreased by an average of 5% annually since 2001, declining from 88.7 cases per 100,000 people in 2001 to 76.3 cases per 100,000 in 2004. However, blacks in 2004 were 8.4 times more likely than whites to be newly diagnosed with HIV (Kaiser Daily HIV/AIDS Report, 2/7/06). In Florida, HIV incidence among blacks dropped from 224 cases per 100,000 people in 1999 to 134 cases per 100,000 in 2004, the study found. According to the AP/Sun, the study's findings indicate that the decline is not because of a reduction in HIV testing among blacks, which increased during the study period. State health researchers also found that new cases of gonorrhea declined among blacks statewide during the same period by more than 7% annually, which indicates that the drop in both might be associated with a decrease in risky sexual behavior. Some health officials and advocates said that although they welcomed the study's findings, HIV among blacks is still high and the disparity between whites and blacks still persists (AP/Gainesville Sun, 2/1). According to the study, HIV incidence among whites in Florida was recorded at 18.8 cases per 100,000 population in 1999 and 18.4 cases per 100,000 population in 2004 (MMWR, 2/1).
- BET from Feb. 4 to Feb. 18 will launch three HIV/AIDS-themed programs aimed at addressing HIV/AIDS-related issues faced by black adolescents and young people -- including stigma, discrimination against men who have sex with men, HIV testing, substance abuse, and the impact of the disease on personal relationships and family. The broadcasts will begin at 12 p.m. ET/PT on Feb. 4 with "Reflections" -- the winning short film from the first Scenarios USA/Rap-It-Up National Story and Scriptwriting Contest -- with encore broadcasts on Feb. 7 at 11 p.m. and Feb. 18 at 12 p.m. BET also will air a 30-minute documentary on the making of the short film -- "Behind the Scenes: Reflections" -- on Feb. 4 at 12:30 p.m., as well as "Odicie" -- the winner of the third annual Rap-It-Up/Black AIDS Short Subject Film Competition -- on Feb. 18 at 12:30 p.m. In addition, BET News on Feb. 7 at 8 p.m. will air a 30-minute show that examines common misconceptions that many young people hold about the disease. BET since 1998 has partnered with the Kaiser Family Foundation on Rap-It-Up, a public education campaign to inform young people about sexual health issues, including HIV/AIDS (BET/Kaiser Family Foundation release, 1/24).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
New Compound Shows Promise In Halting HIV Spread
A new compound has shown promise in halting the spread of HIV by preventing the virus from replicating. Developed by Temple University researchers, 2-5AN6B could someday work as an effective treatment for HIV especially in conjunction with current drug treatments. Their work is published in the January issue of AIDS Research and Human Retroviruses.
A nucleic acid, 2-5AN6B inhibited HIV replication in white blood cells from a group of 18 HIV infected patients by up to 80 percent, regardless of the patients' treatment regimens.
"A cure for HIV infection remains an elusive goal despite the significant impact of current treatments because of the virus' ability to adapt to and resist those treatments, and bypass the immune system's natural defenses," said Robert J. Suhadolnik, Ph.D., prinicipal investigator and professor of biochemistry at Temple University School of Medicine. "This compound prompts the body to restore its natural antiviral defense systems against the invading virus."
Current drugs for HIV work by blocking one of the steps toward virus replication.
"This new anti-HIV compound works by a very different mechanism, and would appear to offer the promise of someday being combined with existing anti-viral therapies for a much more effective treatment. It is also very important that this compound is much less likely to be defeated by the ability of the virus to mutate, a problem often encountered with existing anti-viral drugs," said Thomas Rogers, Ph.D., co-author and professor of pharmacology at Temple.
This work builds on decades of research by the Temple team which was recently awarded a grant from the National Institutes of Health to continue pre-clinical studies on a larger scale. They'll be investigating the molecular mechanisms of 2-5AN6B as a potential weapon against HIV, and continue work on a new therapeutic approach involving gene therapy for the treatment of HIV infection.
###
The other researchers on the team are Dessislava Dimitrova, M.D., Nancy Reichenbach, Xiaowei Yang, M.D., Ph.D., Wolfgang Pfleiderer, Ph.D., Ramamurthy Charubula, Ph.D., John Gaughan, Ph.D., Byungse Suh, M.D., Ph.D. and Earl Henderson, Ph.D, co-investigator. The work was supported by a grant from the National Institutes of Health.
Contact: Eryn Jelesiewicz
Temple University
A nucleic acid, 2-5AN6B inhibited HIV replication in white blood cells from a group of 18 HIV infected patients by up to 80 percent, regardless of the patients' treatment regimens.
"A cure for HIV infection remains an elusive goal despite the significant impact of current treatments because of the virus' ability to adapt to and resist those treatments, and bypass the immune system's natural defenses," said Robert J. Suhadolnik, Ph.D., prinicipal investigator and professor of biochemistry at Temple University School of Medicine. "This compound prompts the body to restore its natural antiviral defense systems against the invading virus."
Current drugs for HIV work by blocking one of the steps toward virus replication.
"This new anti-HIV compound works by a very different mechanism, and would appear to offer the promise of someday being combined with existing anti-viral therapies for a much more effective treatment. It is also very important that this compound is much less likely to be defeated by the ability of the virus to mutate, a problem often encountered with existing anti-viral drugs," said Thomas Rogers, Ph.D., co-author and professor of pharmacology at Temple.
This work builds on decades of research by the Temple team which was recently awarded a grant from the National Institutes of Health to continue pre-clinical studies on a larger scale. They'll be investigating the molecular mechanisms of 2-5AN6B as a potential weapon against HIV, and continue work on a new therapeutic approach involving gene therapy for the treatment of HIV infection.
###
The other researchers on the team are Dessislava Dimitrova, M.D., Nancy Reichenbach, Xiaowei Yang, M.D., Ph.D., Wolfgang Pfleiderer, Ph.D., Ramamurthy Charubula, Ph.D., John Gaughan, Ph.D., Byungse Suh, M.D., Ph.D. and Earl Henderson, Ph.D, co-investigator. The work was supported by a grant from the National Institutes of Health.
Contact: Eryn Jelesiewicz
Temple University
Studies Examine HIV Dementia In Sub-Saharan Africa, CDC's HIV Prevention Budget
The following highlights recently released studies on HIV/AIDS.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
- "Frequency of and Risk Factors for HIV Dementia in an HIV Clinic in Sub-Saharan Africa," Neurology: Ned Sacktor, a neurologist at the Johns Hopkins School of Medicine, and colleagues conducted the study among 178 people in Kampala, Uganda, from September 2003 to January 2004, Xinhuanet reports. Seventy-eight of the participants were HIV-positive and 100 were HIV-negative (Xinhuanet, 1/30). The study found that 31% of participants in the HIV-positive group, or about 25 people, had HIV dementia, while none of the HIV-negative participants had the condition (Fox, Reuters South Africa, 1/29). Researchers characterized HIV dementia as memory, learning, behavioral and motor disabilities that interfere with daily activities and could lead to incapacitation. They diagnosed the dementia by examining participants' medical histories, as well as the results of a series of comprehensive neurological and neuropsychological tests and functional assessments, Xinhuanet reports (Xinhuanet, 1/30). "If the rate we saw in our study translates across sub-Saharan Africa, we're looking at more than eight million people in this region with HIV dementia," Sacktor said (Reuters South Africa, 1/29). According to researchers, HIV dementia can be treated and potentially reversed with the same antiretroviral drugs used to treat the virus, and treatment can sometimes restore normal cognitive function, Xinhuanet reports (Xinhuanet, 1/30).
- "HIV Incidence and CDC's HIV Prevention Budget: An Exploratory Correlational Analysis," American Journal of Preventive Medicine: David Holtgrave of Johns Hopkins University's Bloomberg School of Public Health and Jennifer Kates of the Kaiser Family Foundation examined the relationship between CDC's HIV prevention budget and HIV incidence in the U.S. from 1978 to 2006. The study found that from the beginning of the epidemic to 1985, when new HIV cases peaked in the U.S., HIV incidence predicted levels of investment. During this period, increased amounts of funding were allocated to HIV prevention programs as new HIV cases increased each year. From the mid-1980s, the level of investment predicted incidence, the study found. During this period, the U.S. continued to increase funding for HIV prevention programs, and the number of new cases decreased from 160,000 annually to about 40,000 annually, according to the study. In the early 1990s, as the level of investment leveled out, so did the number of new annual HIV cases, the study found. "Our analysis helps explain why the number of new HIV infections has remained at 40,000 per year for over 15 years," Holtgrave said, adding, "Investment levels have predicted HIV incidence since the mid-1980s. If we want to lower infections further in the U.S., these analyses suggest we should consider increasing our national investment" in HIV prevention programs. Holtgrave said that because the study is based on historical data, it is subject to methodological limitations (JHSPH release, 1/31).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
New York Times Examines Dynamics Between Bush Administration, Congress On Increased Funding For International HIV/AIDS, TB, Malaria Programs
The New York Times on Friday examined recent efforts by the Democrat-led House "to rescue" one of President Bush's "international priorities: the global fight against AIDS, malaria and tuberculosis" (Dugger, New York Times, 2/2). The House on Wednesday voted 286-140 to approve a $463 billion spending resolution (HJ Res 20) for fiscal year 2007 that includes a $1.3 billion increase for international HIV/AIDS, TB and malaria programs. The resolution would bring the total for the President's Emergency Plan for AIDS Relief to $4.5 billion. PEPFAR is a five-year, $15 billion program that directs funding for HIV/AIDS, TB and malaria primarily to 15 focus countries and provides funding to the Global Fund To Fight AIDS, Tuberculosis and Malaria. The $4.5 billion for PEPFAR includes $3.2 billion for the State Department's Global HIV/AIDS Initiative, $712 million for USAID's Child Survival and Health Program, and $494 million for CDC and HHS global HIV/AIDS activities, according to a House Appropriations Committee summary. Of these amounts, $724 million would be allocated for the U.S. contribution to the Global Fund, with $625 million coming from the State Department and USAID, and $99 million from HHS. In addition, $248 million would be allocated to expand programs under the President's Malaria Initiative, an increase of $149 million (Kaiser Daily HIV/AIDS Report, 2/1). The Senate is expected to consider the bill as early as next week. Although the Bush administration's "drive for a rapid strengthening" of HIV/AIDS, TB and malaria programs had been "caught in limbo," the budget approval by the House "suggests the deepening of political support for foreign aid programs," according to the Times. In addition, the steps taken by Congress this week on global health issues "provides a marker of how much both parties have changed" since the administration of former President Clinton because both Democrats and Republicans now must "compete to claim the mantle of leadership" on foreign aid, the Times reports. Aid to Africa under the Bush administration has increased to more than twice the level of any previous administration and more than triple that achieved during the Clinton administration, according to an analysis by the Center for Global Development. "The politics of aid in this country probably has shifted on push-button issues like HIV/AIDS," Todd Moss, a senior CGD fellow, said, adding, "It's the longer-term development that's much harder to do and build political backing for. Those are the things that will come under pressure in a Washington with a split government" (New York Times, 2/2).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
India To Establish 'Safe Zones' To Reduce HIV Transmission Among Migrant Workers
India's National AIDS Control Organization on Thursday announced that it will track migrant worker populations in cities and establish "safe zones" for the workers where they can access HIV peer education, HIV testing centers and condoms, Reuters UK reports. The safe zones will be established under the third phase of NACO's National AIDS Control Plan, which has been allocated a budget of $1.8 billion. About 75% of the control plan's third phase budget is allocated for prevention efforts among high-risk groups, including migrant workers and commercial sex workers. About one-fourth of India's population travels throughout the country annually in search of work. According to NACO Director General Sujatha Rao, the new plan will focus on about 5% of migrant workers in the country. According to Reuters UK, more than half of HIV-positive people in the country live in rural areas, and the virus is spreading because male migrants who travel to cities for work have sex with commercial sex workers and then have sex with their wives when they return home. About half of India's estimated two million sex workers use condoms, and NACO over the next three to four years hopes to increase condom use to 80% among sex workers. In addition, the country by March will increase the number of government treatment centers that provide antiretroviral drugs from 101 to 121. According to NACO, the country's free treatment programs are hindered because an estimated 86% of HIV-positive people in the country are not aware of their status (Zaheer, Reuters UK, 2/1).
Indian State To Require HIV Tests for Married Couples, Politicians
In related news, the Indian state Karnataka plans to pass legislation that would require HIV tests for couples planning to marry and for politicians entering the state Legislature, the Indo-Asian News Service/Daily India reports. Nearly 10% of HIV-positive people in India, or 500,000 people, live in Karnataka, and the state's HIV prevalence is 1.56%, according to the Karnataka State HIV/AIDS Society. According to the Karnataka Health Minister R. Ashok, the state will require the tests for politicians to encourage others to be tested for HIV. India's Ministry of Health and Family Welfare is opposed to mandatory testing, but Ashok said the issue is a state matter, according to Indo-Asian News Service/Daily India. "The state government is free to take new initiatives to control health problems like AIDS," Ashok said, adding, "We know the sensitivity of the issue, but the government needs to do something for the larger benefit of [the] people." The Indian state Andhra Pradesh is planning similar legislation, the Indo-Asian News Service/Daily India reports (Nanda, Indo-Asian News Service/Daily India, 1/31).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Armenian AIDS Commission Approves HIV/AIDS Prevention Program Targeting Teenagers, Young People, Official Says
The Armenian Country Coordination Commission on HIV/AIDS, Tuberculosis and Malaria Issues has approved an HIV/AIDS prevention program for 2007 through 2011 targeting teenagers and young people, Samvel Grigoryan, director of the country's National Center for AIDS Prevention, said recently, ARKA News Agency reports. The country by the end of last year recorded 429 HIV/AIDS cases, 74.4% of which occurred among people ages 29 to 39, and 14.5% of which occurred among people ages 10 to 24, according to ARKA News Agency. Of the recorded cases, 52% occurred through injection drug use and 40.3% through heterosexual sex, and there were three cases of mother-to-child HIV transmission (ARKA News Agency, 2/1). According to a report conducted by a multidisciplinary team with support from UNAIDS, UNICEF and NCAP, prevention programs targeting teenagers and young people are essential to combat the spread of HIV in Armenia, a UNICEF release reports. The report found that 30% of young commercial sex workers, 40% of young injection drug users and less than 50% of young men who have sex with men have a clear understanding of how HIV is transmitted and prevented. The report also found that only 12% of adolescents between ages 10 and 19 living in institutions have sufficient knowledge of HIV prevention. According to the release, Armenia has incorporated the report's recommendations into its national HIV/AIDS prevention program for 2007 to 2011. The recommendations include involving young people in HIV awareness campaigns and peer education programs; ensuring that schools address the disease openly and include it in life skills lessons; creating accessible youth-friendly health care and advisory services; encouraging more inclusive attitudes towards HIV-positive people and those at high risk of transmission; and ensuring a strong gender focus in HIV/AIDS-related policies (UNICEF release, 1/30). According to Grigoryan, the draft program has been submitted to the Armenian government for final approval (ARKA News Agency, 2/1).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Phase III Trials Of Cellulose Sulfate Microbicide For HIV Prevention Closed
CONRAD, a reproductive health research organization, has announced that it has halted a Phase III clinical trial of cellulose sulfate -- a topical microbicide gel being tested for HIV prevention in women -- because preliminary results indicated that cellulose sulfate could lead to an increased risk of HIV infection in women who use the compound. The trial was being conducted in South Africa, Benin, Uganda, and India.
Simultaneously, Family Health International (FHI) has halted a second Phase III cellulose sulfate trial in Nigeria. Although the FHI trial did not detect an increased HIV risk associated with cellulose sulfate, the decision was made as a precautionary measure, given the preliminary results in the CONRAD trial. Cellulose sulfate (CS) was one of four microbicides currently in effectiveness trials for prevention of HIV and other sexually transmitted infections.
At this point, it is not clear why use of cellulose sulfate was associated with an increased risk of HIV infection in the CONRAD trial. The Independent Data Monitoring Committee (IDMC), an independent advisory group of experts overseeing the trial, will conduct a detailed review of the data to better understand the findings, and help determine any implications for other microbicide studies.
Dr. Lut Van Damme, principal investigator of the CONRAD trial, stated: "It was our hope that this product would have helped women in protecting themselves from HIV. While the findings are unexpected and disappointing, we will learn scientifically important information from this trial that will inform future HIV prevention research."
The microbicide, also known as Ushercell, is a cotton-based compound developed by Polydex Pharmaceuticals, based in Toronto, Canada. Prior to beginning the Phase III efficacy trials, there were 11 earlier safety and contraceptive trials on cellulose sulfate involving more than 500 participants in Africa, India, and the U.S. -- none of which identified safety concerns.
Recruitment for the CONRAD Phase III study began in July 2005. The study was conducted in areas of the world where HIV risk is greatest, and where infection occurs primarily through heterosexual intercourse. Half of the participating women were given cellulose sulfate, and half a placebo gel, in a double-blinded randomized trial design. All participants received intensive HIV prevention counseling at each monthly visit and all women were given high-quality condoms free of charge. Participants received regular testing and treatment for sexually transmitted infections. Pregnant women were not included in the study.
Participants were admitted into the study only after receiving detailed information about the purpose of the study and the possible health benefits and risks. During this process, their understanding of the study was assessed prior to their signing a consent form. Each trial site is linked to local organizations that provide care for women who become HIV-infected during the trial. As part of the trial preparation, CONRAD set aside funding for women who become HIV-positive during the trial to ensure adequate health care, including HIV antiretroviral treatment when needed.
Jeff Spieler, Chief of USAID's Research, Technology and Utilization Division, Office of Population and Reproductive Health said, "I am surprised and disappointed by these findings given the pre-clinical effectiveness and safety profile of CS, and its safety profile demonstrated in Phase I trials. I believe strongly that the field learns a great deal from every study, even those with disappointing results. The effort and resources that have been expended in terms of site and infrastructure development, training of clinical and laboratory staff, and community involvement activities will help move the field forward and pave the way to future studies." He continued, "I am also hopeful that one or more of the other microbicide candidates now in Phase III trials, and the next generation of products under development, will be shown to be safe and effective in helping to prevent HIV infection along with other behavioral interventions."
"Developing new tools to prevent HIV -- particularly for women -- is an urgent priority," said Dr. Henry Gabelnick, Executive Director of CONRAD. "We are committed to learning as much as possible from the trials of cellulose sulfate, and will use that knowledge to continue searching for compounds and collecting evidence to find a successful microbicide. Continued support for microbicide research is critical to our eventual success."
Cellulose Sulfate: Clinical Trial History (Safety and Efficacy)
Overview:
Prior to initiating two HIV prevention trials, CONRAD sponsored 11 clinical trials of cellulose sulfate (CS) involving 518 women and 48 men in the CS arms. These studies fall into four categories as follows:
* Safety studies in women -- 5
* Safety studies in men -- 2
* Other (safety of CS when used with a diaphragm and MRI imaging)- 2
* Contraceptive effectiveness studies - 2
Most of the trials were undertaken in the United States (7), one was done in Europe, and three in countries where the HIV prevention trials were expected to be carried out. The contraceptive effectiveness trials were carried out in the United States in mutually monogamous populations at low risk for STIs in which condom counseling was not required.
The safety studies in women and men varied in terms of control group (inactive sexual lubricant such as K-Y? Jelly or active spermicidal gel such as Conceptrol®), frequency of use (once, twice, or four times daily), duration of use (6-14 days), sexual activity (abstinent or active), and HIV status of participants (infected or uninfected). Endpoints included signs and symptoms of genital irritation, colposcopic findings, changes in vaginal microflora and, in some cases, vaginal inflammatory markers, and responses on acceptability questionnaires. The contraceptive studies used the prevention of pregnancy as the primary endpoint. The results of these studies have indicated that CS was as safe, acceptable, and effective as marketed spermicides and sexual lubricants.
The initial safety study was begun in 1999 and the contraceptive effectiveness trial was completed in July, 2006. The results of all eleven clinical studies to date have indicated that CS was as safe, acceptable, and effective as marketed spermicides and sexual lubricants.
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CONRAD is a cooperating agency of USAID committed to improving reproductive health by expanding the contraceptive choices of women and men and by helping to prevent the transmission of HIV/AIDS and other sexually transmitted diseases. CONRAD is administered through the Department of Obstetrics and Gynecology at Eastern Virginia Medical School (EVMS) in Norfolk, VA and headquartered in Arlington, VA.
Contact: Annette Larkin
CONRAD
Simultaneously, Family Health International (FHI) has halted a second Phase III cellulose sulfate trial in Nigeria. Although the FHI trial did not detect an increased HIV risk associated with cellulose sulfate, the decision was made as a precautionary measure, given the preliminary results in the CONRAD trial. Cellulose sulfate (CS) was one of four microbicides currently in effectiveness trials for prevention of HIV and other sexually transmitted infections.
At this point, it is not clear why use of cellulose sulfate was associated with an increased risk of HIV infection in the CONRAD trial. The Independent Data Monitoring Committee (IDMC), an independent advisory group of experts overseeing the trial, will conduct a detailed review of the data to better understand the findings, and help determine any implications for other microbicide studies.
Dr. Lut Van Damme, principal investigator of the CONRAD trial, stated: "It was our hope that this product would have helped women in protecting themselves from HIV. While the findings are unexpected and disappointing, we will learn scientifically important information from this trial that will inform future HIV prevention research."
The microbicide, also known as Ushercell, is a cotton-based compound developed by Polydex Pharmaceuticals, based in Toronto, Canada. Prior to beginning the Phase III efficacy trials, there were 11 earlier safety and contraceptive trials on cellulose sulfate involving more than 500 participants in Africa, India, and the U.S. -- none of which identified safety concerns.
Recruitment for the CONRAD Phase III study began in July 2005. The study was conducted in areas of the world where HIV risk is greatest, and where infection occurs primarily through heterosexual intercourse. Half of the participating women were given cellulose sulfate, and half a placebo gel, in a double-blinded randomized trial design. All participants received intensive HIV prevention counseling at each monthly visit and all women were given high-quality condoms free of charge. Participants received regular testing and treatment for sexually transmitted infections. Pregnant women were not included in the study.
Participants were admitted into the study only after receiving detailed information about the purpose of the study and the possible health benefits and risks. During this process, their understanding of the study was assessed prior to their signing a consent form. Each trial site is linked to local organizations that provide care for women who become HIV-infected during the trial. As part of the trial preparation, CONRAD set aside funding for women who become HIV-positive during the trial to ensure adequate health care, including HIV antiretroviral treatment when needed.
Jeff Spieler, Chief of USAID's Research, Technology and Utilization Division, Office of Population and Reproductive Health said, "I am surprised and disappointed by these findings given the pre-clinical effectiveness and safety profile of CS, and its safety profile demonstrated in Phase I trials. I believe strongly that the field learns a great deal from every study, even those with disappointing results. The effort and resources that have been expended in terms of site and infrastructure development, training of clinical and laboratory staff, and community involvement activities will help move the field forward and pave the way to future studies." He continued, "I am also hopeful that one or more of the other microbicide candidates now in Phase III trials, and the next generation of products under development, will be shown to be safe and effective in helping to prevent HIV infection along with other behavioral interventions."
"Developing new tools to prevent HIV -- particularly for women -- is an urgent priority," said Dr. Henry Gabelnick, Executive Director of CONRAD. "We are committed to learning as much as possible from the trials of cellulose sulfate, and will use that knowledge to continue searching for compounds and collecting evidence to find a successful microbicide. Continued support for microbicide research is critical to our eventual success."
Cellulose Sulfate: Clinical Trial History (Safety and Efficacy)
Overview:
Prior to initiating two HIV prevention trials, CONRAD sponsored 11 clinical trials of cellulose sulfate (CS) involving 518 women and 48 men in the CS arms. These studies fall into four categories as follows:
* Safety studies in women -- 5
* Safety studies in men -- 2
* Other (safety of CS when used with a diaphragm and MRI imaging)- 2
* Contraceptive effectiveness studies - 2
Most of the trials were undertaken in the United States (7), one was done in Europe, and three in countries where the HIV prevention trials were expected to be carried out. The contraceptive effectiveness trials were carried out in the United States in mutually monogamous populations at low risk for STIs in which condom counseling was not required.
The safety studies in women and men varied in terms of control group (inactive sexual lubricant such as K-Y? Jelly or active spermicidal gel such as Conceptrol®), frequency of use (once, twice, or four times daily), duration of use (6-14 days), sexual activity (abstinent or active), and HIV status of participants (infected or uninfected). Endpoints included signs and symptoms of genital irritation, colposcopic findings, changes in vaginal microflora and, in some cases, vaginal inflammatory markers, and responses on acceptability questionnaires. The contraceptive studies used the prevention of pregnancy as the primary endpoint. The results of these studies have indicated that CS was as safe, acceptable, and effective as marketed spermicides and sexual lubricants.
The initial safety study was begun in 1999 and the contraceptive effectiveness trial was completed in July, 2006. The results of all eleven clinical studies to date have indicated that CS was as safe, acceptable, and effective as marketed spermicides and sexual lubricants.
###
CONRAD is a cooperating agency of USAID committed to improving reproductive health by expanding the contraceptive choices of women and men and by helping to prevent the transmission of HIV/AIDS and other sexually transmitted diseases. CONRAD is administered through the Department of Obstetrics and Gynecology at Eastern Virginia Medical School (EVMS) in Norfolk, VA and headquartered in Arlington, VA.
Contact: Annette Larkin
CONRAD
African-American Women Who Have Received HIV Treatment Are Sought To Participate In GRACE Study
The GRACE study (Gender, Race And Clinical Experience) is now recruiting participants for the largest clinical study to date in treatment-experienced adult women with HIV to evaluate gender and race differences in response to an HIV medication. On the occasion of the seventh annual National Black HIV/AIDS Awareness Day on February 7, the study's sponsor, Tibotec Therapeutics Clinical Affairs, a division of Ortho Biotech Clinical Affairs, LLC, is seeking to raise awareness among African-American women of the trial and its importance to the treatment of HIV.
Today, women account for nearly one-third of new HIV diagnoses in the U.S., and rates of HIV infection are particularly high among women of color. African-American women, who represent only 13% of the U.S. female population, account for 64% of female AIDS cases.
"We expect GRACE will be an historic study because HIV treatment trials in treatment-experienced populations have traditionally included small numbers of women and people of color, especially in the earliest studies of new antiretroviral agents. We know that there are gender- and race-specific complications associated with HIV disease. However, we do not know a great deal about how gender and race impact the efficacy and side effects of HIV medications," said Debbie Hagins, M.D., Clinical Director of Outpatient Services, a Ryan White funded clinic in Savannah, GA, and an investigator in the GRACE study.
GRACE, a multi-center, open-label Phase IIIb trial, will compare gender differences in the efficacy, safety and tolerability of PREZISTA (darunavir) tablets administered with ritonavir and other antiretroviral agents over a 48-week treatment period. The study also will explore racial differences in treatment outcomes. Eligibility is open to men and women of all races.
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. PREZISTA received accelerated approval based on the 24- week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) studies. Longer-term data will be required before the FDA can consider traditional approval for PREZISTA (see the full indication and important safety information below).
"As an African-American woman living with HIV for more than 20 years, I am encouraged to see studies like GRACE that are designed to learn more about HIV treatment in treatment-experienced African-Americans and women in the U.S." said Rae Lewis-Thornton, a renowned AIDS activist and Emmy Award-winning journalist. "GRACE is an example of the steps that need to be taken to address the evolving HIV epidemic in the African-American community, and those who participate in GRACE will play a very important role in advancing the understanding of HIV treatment in women and people of color."
The GRACE study will include approximately 50 sites in the United States, Mexico and Canada, and will seek to enroll approximately 420 participants, 70 percent of whom will be women. Participants must be of 18 years or older, have a viral load of 1000 copies/mL or greater and have previous intolerance or failure to prior therapy consisting of a protease inhibitor and/or non- nucleoside reverse transcriptase inhibitor-based highly active antiretroviral treatment regimen of at least 12 weeks. All participants will receive PREZISTA/r (600/100mg twice a day) with an optimized background regimen chosen by the investigator and based on resistance testing and prior treatment history.
Indication
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.
This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled trials of PREZISTA/rtv in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy with PREZISTA/rtv:
-- Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA/rtv.
-- The use of other active agents with PREZISTA/rtv is associated with a greater likelihood of treatment response.
-- The risks and benefits of PREZISTA/rtv have not been established in treatment-naГЇve adult patients or pediatric patients.
Important Safety Information
PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
PREZISTA is contraindicated in patients with known hypersensitivity to any of its ingredients.
Coadministration of PREZISTA/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and have a narrow therapeutic index (e.g., astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, midazolam, or triazolam) and for which elevated plasma concentrations are associated with serious and/or life- threatening events. Coadministration is not recommended with carbamazepine, phenobarbital, phenytoin, rifampin, lopinavir/ritonavir, saquinavir, lovastatin, pravastatin, simvastatin, or products containing St. John's wort (Hypericum perforatum).
Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA/rtv. This list of potential drug interactions is not complete.
PREZISTA must be co-administered with 100 mg ritonavir and food to exert its therapeutic effect. Failure to correctly administer PREZISTA with ritonavir and food will result in reduced plasma concentration of darunavir that will be insufficient to achieve the desired antiviral effect. Please refer to ritonavir prescribing information for additional information on precautionary measures.
Severe skin rash, including erythema multiforme and Stevens-Johnson Syndrome, has been reported in subjects receiving PREZISTA during the clinical development program. In some cases, fever and elevations of transaminases have also been reported. In clinical trials (n=924), rash (all grades, regardless of causality) occurred in seven percent of subjects treated with PREZISTA; discontinuation due to rash was 0.3 percent. Rashes were generally mild-to-moderate, self-limiting and maculopapular. PREZISTA should be discontinued if severe rash develops.
PREZISTA should be used with caution in patients with known sulfonamide allergy.
New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. A causal relationship between protease inhibitors and these events has not been established.
PREZISTA should be used with caution in patients with hepatic impairment. There are no data regarding the use of PREZISTA in patients with varying degrees of hepatic impairment; therefore, specific dosage recommendations cannot be made.
Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long- term consequences of these events have not been established.
Immune reconstitution syndrome has been reported in patients treated with ARV therapy.
The potential for HIV-cross-resistance among protease inhibitors has not been fully explored in PREZISTA/rtv treated patients.
PREZISTA should be used during pregnancy only if the potential benefit justifies the potential risk. There are no adequate and well-controlled studies in pregnant women. The effects of PREZISTA on pregnant women or their unborn babies are not known.
In the pooled analysis of POWER 1 and 2 studies, the most frequently reported drug-related adverse events of at least moderate to severe intensity in patients receiving PREZISTA/rtv-containing regimen were headache (3.8 percent), diarrhea (2.3 percent), abdominal pain (2.3 percent), constipation (2.3 percent), and vomiting (1.5 percent).
Please see full Prescribing Information for more details.
About PREZISTA
PREZISTA was developed by Tibotec Pharmaceuticals Ltd. and is marketed in the U.S. by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.
About Tibotec Pharmaceuticals Ltd.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Tibotec Pharmaceuticals is developing a Global Access Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The Global Access Program includes access pricing, registration, medical education for appropriate use and voluntary licensing.
Tibotec Therapeutics
http://www.tibotectherapeutics.com
Today, women account for nearly one-third of new HIV diagnoses in the U.S., and rates of HIV infection are particularly high among women of color. African-American women, who represent only 13% of the U.S. female population, account for 64% of female AIDS cases.
"We expect GRACE will be an historic study because HIV treatment trials in treatment-experienced populations have traditionally included small numbers of women and people of color, especially in the earliest studies of new antiretroviral agents. We know that there are gender- and race-specific complications associated with HIV disease. However, we do not know a great deal about how gender and race impact the efficacy and side effects of HIV medications," said Debbie Hagins, M.D., Clinical Director of Outpatient Services, a Ryan White funded clinic in Savannah, GA, and an investigator in the GRACE study.
GRACE, a multi-center, open-label Phase IIIb trial, will compare gender differences in the efficacy, safety and tolerability of PREZISTA (darunavir) tablets administered with ritonavir and other antiretroviral agents over a 48-week treatment period. The study also will explore racial differences in treatment outcomes. Eligibility is open to men and women of all races.
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. PREZISTA received accelerated approval based on the 24- week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) studies. Longer-term data will be required before the FDA can consider traditional approval for PREZISTA (see the full indication and important safety information below).
"As an African-American woman living with HIV for more than 20 years, I am encouraged to see studies like GRACE that are designed to learn more about HIV treatment in treatment-experienced African-Americans and women in the U.S." said Rae Lewis-Thornton, a renowned AIDS activist and Emmy Award-winning journalist. "GRACE is an example of the steps that need to be taken to address the evolving HIV epidemic in the African-American community, and those who participate in GRACE will play a very important role in advancing the understanding of HIV treatment in women and people of color."
The GRACE study will include approximately 50 sites in the United States, Mexico and Canada, and will seek to enroll approximately 420 participants, 70 percent of whom will be women. Participants must be of 18 years or older, have a viral load of 1000 copies/mL or greater and have previous intolerance or failure to prior therapy consisting of a protease inhibitor and/or non- nucleoside reverse transcriptase inhibitor-based highly active antiretroviral treatment regimen of at least 12 weeks. All participants will receive PREZISTA/r (600/100mg twice a day) with an optimized background regimen chosen by the investigator and based on resistance testing and prior treatment history.
Indication
PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/r) and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.
This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled trials of PREZISTA/rtv in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy with PREZISTA/rtv:
-- Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA/rtv.
-- The use of other active agents with PREZISTA/rtv is associated with a greater likelihood of treatment response.
-- The risks and benefits of PREZISTA/rtv have not been established in treatment-naГЇve adult patients or pediatric patients.
Important Safety Information
PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
PREZISTA is contraindicated in patients with known hypersensitivity to any of its ingredients.
Coadministration of PREZISTA/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and have a narrow therapeutic index (e.g., astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, midazolam, or triazolam) and for which elevated plasma concentrations are associated with serious and/or life- threatening events. Coadministration is not recommended with carbamazepine, phenobarbital, phenytoin, rifampin, lopinavir/ritonavir, saquinavir, lovastatin, pravastatin, simvastatin, or products containing St. John's wort (Hypericum perforatum).
Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA/rtv. This list of potential drug interactions is not complete.
PREZISTA must be co-administered with 100 mg ritonavir and food to exert its therapeutic effect. Failure to correctly administer PREZISTA with ritonavir and food will result in reduced plasma concentration of darunavir that will be insufficient to achieve the desired antiviral effect. Please refer to ritonavir prescribing information for additional information on precautionary measures.
Severe skin rash, including erythema multiforme and Stevens-Johnson Syndrome, has been reported in subjects receiving PREZISTA during the clinical development program. In some cases, fever and elevations of transaminases have also been reported. In clinical trials (n=924), rash (all grades, regardless of causality) occurred in seven percent of subjects treated with PREZISTA; discontinuation due to rash was 0.3 percent. Rashes were generally mild-to-moderate, self-limiting and maculopapular. PREZISTA should be discontinued if severe rash develops.
PREZISTA should be used with caution in patients with known sulfonamide allergy.
New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. A causal relationship between protease inhibitors and these events has not been established.
PREZISTA should be used with caution in patients with hepatic impairment. There are no data regarding the use of PREZISTA in patients with varying degrees of hepatic impairment; therefore, specific dosage recommendations cannot be made.
Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long- term consequences of these events have not been established.
Immune reconstitution syndrome has been reported in patients treated with ARV therapy.
The potential for HIV-cross-resistance among protease inhibitors has not been fully explored in PREZISTA/rtv treated patients.
PREZISTA should be used during pregnancy only if the potential benefit justifies the potential risk. There are no adequate and well-controlled studies in pregnant women. The effects of PREZISTA on pregnant women or their unborn babies are not known.
In the pooled analysis of POWER 1 and 2 studies, the most frequently reported drug-related adverse events of at least moderate to severe intensity in patients receiving PREZISTA/rtv-containing regimen were headache (3.8 percent), diarrhea (2.3 percent), abdominal pain (2.3 percent), constipation (2.3 percent), and vomiting (1.5 percent).
Please see full Prescribing Information for more details.
About PREZISTA
PREZISTA was developed by Tibotec Pharmaceuticals Ltd. and is marketed in the U.S. by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.
About Tibotec Pharmaceuticals Ltd.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Tibotec Pharmaceuticals is developing a Global Access Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The Global Access Program includes access pricing, registration, medical education for appropriate use and voluntary licensing.
Tibotec Therapeutics
http://www.tibotectherapeutics.com
Preclinical Trial Results Of GeoVax's Vaccines Demonstrate Potential To Protect Against Development Of AIDS
GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta-based biotechnology company, today reported successful results from a preclinical trial using GeoVax's vaccines for the therapeutic treatment and prevention of Acquired Immunodeficiency Disease Syndrome ("AIDS") in non-human primates. The data demonstrate the effectiveness of GeoVax's DNA/MVA vaccines in controlling the Simian ("SIV") AIDS virus through immune responses raised by the vaccines. These promising results have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's vaccines.
In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines.
The reduction of virus levels in the blood stream of these AIDS virus- infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.
"The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS," said Don Hildebrand, CEO of GeoVax Labs. "Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines."
The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.
The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.
These studies were conducted at Emory University and were supported by funding from the National Institutes of Health.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
GeoVax Labs, Inc.
http://www.geovax.com/
In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines.
The reduction of virus levels in the blood stream of these AIDS virus- infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.
"The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS," said Don Hildebrand, CEO of GeoVax Labs. "Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines."
The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.
The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.
These studies were conducted at Emory University and were supported by funding from the National Institutes of Health.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
GeoVax Labs, Inc.
http://www.geovax.com/
Demand For Male Circumcision As HIV Prevention Method Growing In Swaziland
The demand for male circumcision is beginning to "sweep" across Swaziland as people seek ways prevent to the spread of HIV, AFP/Mail and Guardian reports (Blandy, AFP/Mail and Guardian, 2/2). Data from two studies conducted in Kenya and Uganda released in December 2006 by NIH indicate that routine male circumcision could reduce a man's HIV infection risk through heterosexual sex by about 50%. According to researchers, male circumcision eliminates the cells most vulnerable to HIV. In addition, a circumcised penis develops thicker skin that is resistant to HIV infection. The results of the Uganda and Kenya studies were similar to the results of a study conducted in South Africa in 2005 (Kaiser Daily HIV/AIDS Report, 1/19). To try to meet the growing demand, doctors at the government hospital in the capital, Mbabane, are being trained and are requested to assist in special "circumcision days," when men can undergo the procedure at no cost. On those days, roughly 40 men get circumcised, but up to 100 additional men regularly are turned away because of the lack of professional medical staff available to perform the procedure. According to urologist Adam Groenevald, circumcising 200,000 men will require 40,000 operations to be performed annually for the next five years. In addition, there are "deeper-rooted and more cultural barriers" to circumcision in Swaziland, as boys in the country traditionally are not circumcised, AFP/Mail and Guardian reports. Swaziland's health ministry is waiting for advice from the World Health Organization before rolling out a mass circumcision program. "We have to make the medical establishment and policymakers ready for the go ahead," Groenevald said, adding, "If we are not ready and the go ahead comes, there will be chaos. A number of unqualified people will start offering circumcisions, and we need to avoid that at all costs." According to Faith Dlamini of the National Emergency Response Council on HIV/AIDS, the government would focus initially on circumcisions among boys and men ages 15 to 30 who are most vulnerable to HIV transmission. UNICEF estimates that HIV prevalence among men ages 20 to 30 in the country is almost 50%, which is higher than the national adult prevalence (AFP/Mail and Guardian, 2/2).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
WHO Cautions Thailand Against Issuing Compulsory License For Abbott's Antiretroviral Kaletra
The World Health Organization on Thursday cautioned the Thai government on its decision to allow the country to produce a lower-cost version of Abbott Laboratories' antiretroviral drug Kaletra by granting a compulsory license for the drug, the Bangkok Post reports (Treerutkuarkul, Bangkok Post, 2/2). Thailand's Ministry of Public Health last week said that it had broken a patent on Kaletra by issuing a compulsory license and Health Minister Mongkol na Songkhla announced that the compulsory license was signed into law and took effect on Jan. 26. World Trade Organization regulations allow governments to declare a "national emergency" and issue compulsory licenses without consulting the foreign patent owner. Thailand, which has 580,000 people living with HIV/AIDS, has won international recognition for its quick launch of a national drug program that treats more than 82,000 HIV-positive people. However, the government's commitment to providing universal access to care is facing increasingly high drug costs. The compulsory license could save the country as much as $24 million annually (Kaiser Daily HIV/AIDS Report, 1/30). WHO Director-General Margaret Chan during a visit to Thailand's National Health Security Office said the country should negotiate the price of Kaletra with Abbott before issuing a compulsory license and encouraged the nation's public health ministry to improve its relationship with drug companies. "I'd like to underline that we have to find a right balance for compulsory licensing," Chan said, adding, "We can't be naive about this. There is no perfect solution for accessing drugs in both quality and quantity." Nimit Tienudom, president of Thailand's AIDS Access Foundation, said that Chan's position was "disappointing" and that WHO "should have supported drug access and promoted the study of quality and inexpensive drugs for the sake of the global population rather than supporting pharmaceutical giants." Mongkol did not comment on Chan's position, according to the Post. Approximately 108,000 of people living with HIV/AIDS in Thailand depend on GPO-VIR, a generic, first-line antiretroviral produced by the country's Government Pharmaceutical Organization. About 20,000 HIV-positive people have developed resistance to the drug and require Kaletra. The country's Pharmaceutical Research and Manufacturers Association has said that it disapproves of the license and that it could lead to Thailand's isolation from the global biotechnology community, the Post reports (Bangkok Post, 2/2).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
AIDS Memorial Quilt Should Be Displayed In Entirety To Raise Profile, Understanding Of HIV/AIDS, Letter To Editor Says
The Atlanta-based Names Project Foundation -- which is involved in a lawsuit over the AIDS Memorial Quilt with Cleve Jones, who started the quilt in 1987 and served as its spokesperson for 15 years -- should "let go" of the quilt and "assist in displaying it in its entirety" to raise the profile and understanding of HIV/AIDS in the U.S., Jerry Clark, founder and CEO of the not-for-profit We Care Minnesota, writes in a New York Times letter to the editor in response to a Jan. 31 Times article (Clark, New York Times, 2/4). Jones and NPF in December 2005 reached an agreement on the issue of returning a portion of the quilt to San Francisco. Under the agreement, Jones will receive 35 blocks of the quilt after he creates a San Francisco-based organization to oversee them. According to the agreement, Jones was required to establish a "501(c)(3) nonprofit organization that will have the name of San Francisco Bay Area Friends of the AIDS Memorial Quilt" by Dec. 31, 2006. The settlement stipulated that if the deadline was not met, the foundation would be "relieved of any obligation to supply blocks of the quilt to the nonprofit." Jones said that he established a not-for-profit by the deadline through the San Francisco-based Tides Center, which oversees more than 200 projects. The dispute arises from the Tide Center's Web site, which states that it is "legally and financially responsible for all Tides Center projects and activities" and that "[p]rojects are not separate entities or affiliated organizations -- projects are Tides Center." An attorney for NPF in January said Jones has not met the requirement (Kaiser Daily HIV/AIDS Report, 1/31). "If the quilt were displayed in its entirety, the country might just wake up" to the impact of HIV/AIDS, Clark writes, adding that increased funding for research and prevention efforts "would be a natural result of raising the profile and understanding of this terrible disease" (New York Times, 2/4).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
New Washington, D.C., HIV/AIDS Administration Director Pane Announces Initiatives To Fight City's Epidemic
The director of Washington, D.C.'s Administration for HIV Policy and Programs, Gregg Pane, who replaced Marsha Martin in January, has announced plans to launch a series of "critical tasks" within the next 90 days aimed at addressing the district's HIV/AIDS epidemic, the AP/Washington Examiner reports (AP/Washington Examiner, 2/4). District Mayor Adrian Fenty in January confirmed that he would not reappoint Martin as director of the city's HIV/AIDS administration. Martin's 16-month tenure as director of the HIV administration earned mixed reviews. Although she was lauded for increasing awareness about HIV/AIDS in the district, she was criticized for her method of collaborating and coordinating with the HIV/AIDS community (Kaiser Daily HIV/AIDS Report, 1/4). Pane's HIV/AIDS initiatives include developing response and prevention plans, increasing condom distribution and enhancing HIV/AIDS case tracking, according to the AP/Examiner. Under the campaign, the administration by mid-February will distribute 250,000 condoms to 60 not-for-profits, and HIV rapid test kits will be distributed to physicians. The administration also is developing a comprehensive HIV prevention plan that will target young people, assess grant management and conduct oversight visits of the government's service providers. In addition, Pane said that the administration plans to enter 1,200 backlogged HIV surveillance cases into city databases, which are needed to accurately record the extent of the epidemic and apply for federal grant money, the AP/Examiner reports. "I felt action was needed," Pane said last week, adding, "We're all saying it's a crisis. Let's do something. Shake it up and set some goals." The DC Appleseed Center for Law and Justice contributed to planning the initiatives, Pane said. Appleseed Center Executive Director Walter Smith said, "My reaction is it's a very good thing that Dr. Pane this quickly is trying to get organized and give this thing high priority, high visibility" (AP/Washington Examiner, 2/4).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
March 5, 2007
Texas AG Abbott Rules That State Law Permits Prison Officials To Mandate HIV Testing Among State Prisoners
Texas Attorney General Greg Abbott (R) on Thursday ruled that state law permits the Texas Board of Criminal Justice to mandate HIV testing among inmates upon entry to state prisons, the Houston Chronicle reports (Babineck, Houston Chronicle, 2/2). The state prison system in August 2006 had proposed a change to its HIV testing policy from saying new inmates "should be tested" upon entering prison to saying they "shall be tested" unless they opt out of testing. State Sen. Rodney Ellis (D) in August 2006 asked Abbott to rule whether current state law allows mandatory HIV testing for prisoners upon entry. Ellis -- who with state Rep. Yvonne Davis (D) sponsored legislation approved last year that requires inmates to be tested for HIV before departing prison -- said if Abbott ruled that current law does not allow mandated entry tests, he would sponsor a bill that would include such a requirement. About 80% of inmates have agreed to take an HIV test upon entering prison since the state began its testing program, and prison system statistics show more than 38,700 inmates received HIV tests in 2005. Of those, 372 tested HIV-positive. Texas law mandates that HIV test results are confidential and that HIV-positive inmates are not separated from HIV-negative inmates. Advocates for mandatory HIV testing upon entry into the prison system say it would help prison officials properly treat HIV-positive people, would provide more accurate data on the spread of the disease and could help officials estimate how many people are becoming HIV-positive in prison. July 2006 statistics show that of 154,000 prisoners in Texas, 2,627 are HIV-positive (Kaiser Daily HIV/AIDS Report, 8/24/06). Abbott's opinion, which leaves the decision regarding mandatory testing up to the Texas Department of Criminal Justice, says that TBCJ is "authorized to adopt a rule or policy requiring mandatory" HIV testing among "incoming offenders in both the institutional division and the state jail division." According to TDCJ spokesperson Jason Clark, there is no indication that the department is planning to make HIV testing among incoming prisoners mandatory anytime soon. Ellis did not comment on Abbott's ruling, the Chronicle reports (Houston Chronicle, 2/2).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
26 Years And HIV/AIDS Continues Unchecked
February marks the seventh annual observance of National Black HIV/AIDS Awareness Day (NBHAAD). This national mobilization effort is designed to encourage African Americans nationwide to become more knowledgeable about the human immunodeficiency virus (HIV) infections and the Acquired Immunodeficiency Syndrome (AIDS) disease, to get tested to know one's HIV status, and to seek treatment for HIV/AIDS. African Americans represent an estimated 13 percent of the U.S. population, yet the Centers for Disease Control and Prevention (CDC) reports 49 percent of those currently living with AIDS in this country are African American.
"Special events such as free HIV/AIDS testing, town hall meetings, candlelight vigils and faith-based programs are being held throughout the country. However, we must do more to stop the spread of this disease," said Albert W. Morris, M.D., president of the National Medical Association (NMA).
Despite 26 years of dealing with the disease, HIV/AIDS continues to be a critical health crisis for African Americans. The NMA strongly recommends that everyone be tested for HIV because there are a significant number of individuals who are unaware that they are infected and have never been diagnosed. "What is most disturbing regarding this epidemic is that we continue to diagnose African Americans at an advanced stage at their initial diagnosis. These individuals do not receive the benefits from early treatment which can prolong their lives," said, Dr. Virginia Caine, director, Marion County Health Department (Indiana) and NMA member.
According to the National Center for Health Statistics 2006 Report, HIV/AIDS is one of the top ten leading causes of death for African Americans. In the same year, African Americans accounted for more than half (54 percent) of the estimated new HIV infections in the United States. "It is clear that African Americans have been ravaged by this disease," says Los Angeles physician and director of the OASIS Clinic, Dr. Wilbert Jordan.
"The NMA supports the CDC recommendations and strongly recommends that physicians and other healthcare professionals offer routine HIV testing to their patients," concluded Dr. Morris. To support the NMA's call-to-action, Dr. Bennett Desdaier, president of the NMA affiliate, Aesculapian Medical Society in Indianapolis, Indiana; Dr. Wilbert Jordan, Los Angles; Dr. Robert Cater, Indianapolis; Dr. Mercy Obeime, Indianapolis; and Dr. Rodney Hood, San Diego are but a few of NMA physicians offering HIV testing from their offices to patients.
While NBHAAD is a nationwide effort, organizers have issued a Call to Action to cities, (e.g., Washington, DC; Atlanta, GA; Newark, NJ; Gary, IN; East St. Louis, IL; Baltimore, MD and others with high incidences of HIV and AIDS for African Americans) to host a "RE-Sound the Alarm" to ensure that Black communities realize that the epidemic continues to spread.
For additional information on National Black HIV/AIDS Awareness Day 2007, see http://www.blackaidsday.org. For additional information on HIV/AIDS see http://www.cdc.gov. The NMA is oldest and largest organization which represents the interests of over 30,000 Black physicians and their patients. For additional information, visit http://www.NMAnet.org.
National Medical Association
http://www.NMAnet.org
"Special events such as free HIV/AIDS testing, town hall meetings, candlelight vigils and faith-based programs are being held throughout the country. However, we must do more to stop the spread of this disease," said Albert W. Morris, M.D., president of the National Medical Association (NMA).
Despite 26 years of dealing with the disease, HIV/AIDS continues to be a critical health crisis for African Americans. The NMA strongly recommends that everyone be tested for HIV because there are a significant number of individuals who are unaware that they are infected and have never been diagnosed. "What is most disturbing regarding this epidemic is that we continue to diagnose African Americans at an advanced stage at their initial diagnosis. These individuals do not receive the benefits from early treatment which can prolong their lives," said, Dr. Virginia Caine, director, Marion County Health Department (Indiana) and NMA member.
According to the National Center for Health Statistics 2006 Report, HIV/AIDS is one of the top ten leading causes of death for African Americans. In the same year, African Americans accounted for more than half (54 percent) of the estimated new HIV infections in the United States. "It is clear that African Americans have been ravaged by this disease," says Los Angeles physician and director of the OASIS Clinic, Dr. Wilbert Jordan.
"The NMA supports the CDC recommendations and strongly recommends that physicians and other healthcare professionals offer routine HIV testing to their patients," concluded Dr. Morris. To support the NMA's call-to-action, Dr. Bennett Desdaier, president of the NMA affiliate, Aesculapian Medical Society in Indianapolis, Indiana; Dr. Wilbert Jordan, Los Angles; Dr. Robert Cater, Indianapolis; Dr. Mercy Obeime, Indianapolis; and Dr. Rodney Hood, San Diego are but a few of NMA physicians offering HIV testing from their offices to patients.
While NBHAAD is a nationwide effort, organizers have issued a Call to Action to cities, (e.g., Washington, DC; Atlanta, GA; Newark, NJ; Gary, IN; East St. Louis, IL; Baltimore, MD and others with high incidences of HIV and AIDS for African Americans) to host a "RE-Sound the Alarm" to ensure that Black communities realize that the epidemic continues to spread.
For additional information on National Black HIV/AIDS Awareness Day 2007, see http://www.blackaidsday.org. For additional information on HIV/AIDS see http://www.cdc.gov. The NMA is oldest and largest organization which represents the interests of over 30,000 Black physicians and their patients. For additional information, visit http://www.NMAnet.org.
National Medical Association
http://www.NMAnet.org
UNAIDS To Introduce HIV Testing Guidelines In India That Recommend Provider-Initiated Testing, Counseling
UNAIDS in March plans to introduce new HIV testing guidelines in India that recommend health care providers initiate testing and counseling, the Hindustan Times reports. Under the country's current HIV testing policy, tests are provided only when people request them. Requests for HIV tests in general are low, and about one in 10 HIV-positive people in India are aware of their status, the Times reports. The new guidelines emphasize informed consent and counseling before an HIV test can be administered, according to the Times. Denis Broun, UNAIDS India coordinator, said the group does not "support mandatory testing. Testing must be confidential, include counseling and occur only with informed consent." He added that no one will be "forced into testing, as the rules of opting out are very clear." In addition, the new testing guidelines will "phenomenally" increase the number of people receiving HIV tests in the country, Broun said, adding that the guidelines "aim to reach the nine in 10 undiagnosed [HIV-positive] people who miss out on treatment." However, some human rights advocates have said that India does not have the health infrastructure to provide treatment and care for the thousands of people who will test positive for HIV, the Times reports. "The government cannot test people and send them away," Anjali Gopalan, executive director of Naz Foundation India Trust, said, adding, "India first needs to ensure proper counseling, upgrade voluntary testing and counseling centers, and set up the required facilities in states that have no health infrastructure or social security for people to fall back on." Loon Gangte, president of the Delhi Network of Positive People, said, "Before scaling up HIV testing, the government must ensure there is no stigma and discrimination" against HIV-positive people. He added that the government "must also provide assured access to treatment and care services." According to Broun, provider-initiated testing has increased the number of people receiving HIV tests in several East African countries, including Botswana, Malawi and Uganda (Sharma, Hindustan Times, 2/1).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Boston Globe Reports On Internal Investigation Of Global Fund Practices
The Boston Globe on Monday reported on an internal inspector general investigation into the business expense practices of the executive director of the Global Fund To Fight AIDS, Tuberculosis and Malaria. According to the Globe's description of the investigation, which was completed in August 2006, Global Fund Executive Director Richard Feachem has "made extensive use of a little-known private bank account, spending hundreds of thousands of dollars on limousines, expensive meals, boat cruises and other expenses." According to the Globe, a separate investigation by the World Health Organization also "raised concerns" over use of the account. Global Fund spokesperson Jon Liden said, "These expenses are reasonable and necessary for carrying out the business of the Global Fund," adding that the report is of "extraordinarily poor quality in terms of accuracy, context and fairness. We have nothing to hide." (Donnelly, Boston Globe, 2/5) The Global Fund in a release on Monday provided comments and clarifications on a "number of untrue or misleading statements" made in the Globe article (Global Fund release, 2/5).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Few HIV-Positive Parents Make Formal Guardianship Arrangements For Their Children
Few unmarried parents who are HIV-positive have made legally documented arrangements for who would care for their children if the parents die, according to a survey by the RAND Corporation.
RAND, a non-profit research organization, analyzed interviews with 222 unmarried parents with a total of 391 children from a nationally representative sample of HIV-infected adults. Of those parents:
* 12 percent had not identified a guardian for their children.
* 6 percent had identified a guardian but hadn't discussed their preference with the guardian.
* 53 percent said the guardian had agreed to be the guardian. * Only 28 percent had prepared legal documentation of their guardianship choice.
Studies have found that children who lose a parent to HIV/AIDS have higher rates of depression, risky sexual behaviors and other emotional and behavioral problems, making them vulnerable.
If parents have guardianship arrangements solidly in place - through a will or standby guardianship - they could help ease the trauma their children would suffer when losing a parent, because a guardianship plan can reduce the chances that children would be separated from their siblings or spend long periods of time in foster care.
"Ideally, we hope our findings will make physicians, especially pediatricians treating children who have HIV-positive parents, more aware of the guardianship issue, and more likely to talk to parents about the importance of making formal arrangements," said lead author Burton O. Cowgill. Cowgill is a researcher at the UCLA/RAND Center for Adolescent Health Promotion and a Ph.D candidate in the Department of Health Services in the School of Public Health at UCLA.
"All parents - not just parents with HIV or other, chronic illnesses - should consider a guardianship plan," Cowgill said. "By identifying who you want to be the guardian, you reduce the possibility of your children ending up with someone you don't want them to be with."
The RAND Health study, "Guardianship Planning Among HIV-Infected Parents in the United States," appears in the February issue of the journal Pediatrics. It was funded by the National Institute of Child Health and Human Development and the U.S. Centers for Disease Control and Prevention.
"I think parents often assume that if anything happens to them, then grandma, an uncle, or a close friend who spends a lot of time with their children will become the guardian, but the legal system doesn't always function the way parents assume it will," said Dr. Mark A. Schuster, senior author of the study and director of health promotion and disease prevention at RAND.
"Parents in two-parent families don't always consider that something could happen to both parents, and then the child can get caught in a tug-of-war among surviving family members," said Schuster, who is also professor of pediatrics and public health at UCLA's Mattel Children's Hospital.
One study of cancer patients who were single parents found that the children of 40 percent of them eventually became wards of people who the deceased parents would have opposed.
HIV-infected parents were most likely to have formalized guardianship arrangements if they were in poor health or were living with no other adults. The study also found that the age of the child had no impact on whether guardianship plans were more fully developed.
Among parents who identified a guardian, 36 percent listed a grandparent, followed by another relative (34 percent), the other biological parent (17 percent), a friend (7 percent), a spouse/partner who was not the biological parent (2 percent), an unrelated adoptive or foster parent (1 percent), and "other" (3 percent). Fathers were less likely than mothers to choose non-relatives.
The study used two waves of data from January 1996 to April 1997 and follow-up interviews from December 1996 through June 1997. The study drew on data collected for the HIV Cost and Services Utilization Study, a landmark study conducted by RAND.
Although the data are a decade old, Cowgill said the study is still relevant for several reasons, including the fact that it was drawn from a national probability sample of mothers and fathers, giving a more comprehensive picture. Past studies have been based on regional data, or were race- or gender-specific.
Also, the use of highly active antiretroviral therapy - which allows HIV-positive people to live longer with HIV - has become more common in the years since the data were collected. Since the study found that healthier parents were more likely to have no formal guardianship arrangements, it is likely that even fewer HIV-positive parents are making formal arrangements today.
Schuster said there were several reasons why HIV-positive parents might fail to make sure a legal guardianship was in place. Parents may have assumed that relatives or friends would step in and no one else would challenge the arrangements.
Parents also may fail to make formal guardianship arrangements because of distrust of the legal system, depression, fear that they can't afford a lawyer and not being aware of free or reduced fee legal services, or fear of being judged negatively due to their HIV-positive status. There's also the very human tendency to procrastinate and reluctance to face one's own mortality, Schuster said.
Other authors of the study are Marc N. Elliott, Megan K. Beckett, and Annie J. Zhou, all of RAND; Rosalie Corona, of Virginia Commonwealth University; and Michelle T. Parra, of the Los Angeles Department of Health Services.
RAND Health, a division of the RAND Corporation, is the nation's largest independent health policy research program, with a broad research portfolio that focuses on quality, costs and delivery, among other topics.
About the RAND Corporation
The RAND Corporation is a nonprofit research organization providing objective analysis and effective solutions that address the challenges facing the public and private sectors around the world.
Contact: RAND Office of Media Relations
RAND Corporation
RAND, a non-profit research organization, analyzed interviews with 222 unmarried parents with a total of 391 children from a nationally representative sample of HIV-infected adults. Of those parents:
* 12 percent had not identified a guardian for their children.
* 6 percent had identified a guardian but hadn't discussed their preference with the guardian.
* 53 percent said the guardian had agreed to be the guardian. * Only 28 percent had prepared legal documentation of their guardianship choice.
Studies have found that children who lose a parent to HIV/AIDS have higher rates of depression, risky sexual behaviors and other emotional and behavioral problems, making them vulnerable.
If parents have guardianship arrangements solidly in place - through a will or standby guardianship - they could help ease the trauma their children would suffer when losing a parent, because a guardianship plan can reduce the chances that children would be separated from their siblings or spend long periods of time in foster care.
"Ideally, we hope our findings will make physicians, especially pediatricians treating children who have HIV-positive parents, more aware of the guardianship issue, and more likely to talk to parents about the importance of making formal arrangements," said lead author Burton O. Cowgill. Cowgill is a researcher at the UCLA/RAND Center for Adolescent Health Promotion and a Ph.D candidate in the Department of Health Services in the School of Public Health at UCLA.
"All parents - not just parents with HIV or other, chronic illnesses - should consider a guardianship plan," Cowgill said. "By identifying who you want to be the guardian, you reduce the possibility of your children ending up with someone you don't want them to be with."
The RAND Health study, "Guardianship Planning Among HIV-Infected Parents in the United States," appears in the February issue of the journal Pediatrics. It was funded by the National Institute of Child Health and Human Development and the U.S. Centers for Disease Control and Prevention.
"I think parents often assume that if anything happens to them, then grandma, an uncle, or a close friend who spends a lot of time with their children will become the guardian, but the legal system doesn't always function the way parents assume it will," said Dr. Mark A. Schuster, senior author of the study and director of health promotion and disease prevention at RAND.
"Parents in two-parent families don't always consider that something could happen to both parents, and then the child can get caught in a tug-of-war among surviving family members," said Schuster, who is also professor of pediatrics and public health at UCLA's Mattel Children's Hospital.
One study of cancer patients who were single parents found that the children of 40 percent of them eventually became wards of people who the deceased parents would have opposed.
HIV-infected parents were most likely to have formalized guardianship arrangements if they were in poor health or were living with no other adults. The study also found that the age of the child had no impact on whether guardianship plans were more fully developed.
Among parents who identified a guardian, 36 percent listed a grandparent, followed by another relative (34 percent), the other biological parent (17 percent), a friend (7 percent), a spouse/partner who was not the biological parent (2 percent), an unrelated adoptive or foster parent (1 percent), and "other" (3 percent). Fathers were less likely than mothers to choose non-relatives.
The study used two waves of data from January 1996 to April 1997 and follow-up interviews from December 1996 through June 1997. The study drew on data collected for the HIV Cost and Services Utilization Study, a landmark study conducted by RAND.
Although the data are a decade old, Cowgill said the study is still relevant for several reasons, including the fact that it was drawn from a national probability sample of mothers and fathers, giving a more comprehensive picture. Past studies have been based on regional data, or were race- or gender-specific.
Also, the use of highly active antiretroviral therapy - which allows HIV-positive people to live longer with HIV - has become more common in the years since the data were collected. Since the study found that healthier parents were more likely to have no formal guardianship arrangements, it is likely that even fewer HIV-positive parents are making formal arrangements today.
Schuster said there were several reasons why HIV-positive parents might fail to make sure a legal guardianship was in place. Parents may have assumed that relatives or friends would step in and no one else would challenge the arrangements.
Parents also may fail to make formal guardianship arrangements because of distrust of the legal system, depression, fear that they can't afford a lawyer and not being aware of free or reduced fee legal services, or fear of being judged negatively due to their HIV-positive status. There's also the very human tendency to procrastinate and reluctance to face one's own mortality, Schuster said.
Other authors of the study are Marc N. Elliott, Megan K. Beckett, and Annie J. Zhou, all of RAND; Rosalie Corona, of Virginia Commonwealth University; and Michelle T. Parra, of the Los Angeles Department of Health Services.
RAND Health, a division of the RAND Corporation, is the nation's largest independent health policy research program, with a broad research portfolio that focuses on quality, costs and delivery, among other topics.
About the RAND Corporation
The RAND Corporation is a nonprofit research organization providing objective analysis and effective solutions that address the challenges facing the public and private sectors around the world.
Contact: RAND Office of Media Relations
RAND Corporation
Washington County Records Four Cases Of Drug-Resistant HIV
Four men in King County, Washington, have been diagnosed with a strain of HIV that is resistant to at least two types of antiretroviral drugs, and health officials on Thursday said they are concerned the strain could spread, the Seattle Times reports. According to the Times, a third antiretroviral has limited effectiveness against the strain (King, Seattle Times, 2/2). Officials said that the same genetic strain of HIV was recorded within 15 months among the men, who were diagnosed with the drug-resistant strain as soon as they tested HIV positive. The men used methamphetamine and had multiple anonymous sexual partners, including men. None of the men was known to have had sex with any of the other three, according to officials (AP/Houston Chronicle, 2/2). Some of the men's partners have been identified, none of whom has tested positive for the resistant strain, Bob Wood, HIV/AIDS program director for the Seattle-King County Public Health Department, said. There is no information about how easily this strain might be transmitted or whether it was spread to Seattle from another city. The agency plans to distribute fliers in gay bars and bathhouses about the HIV strain, and physicians are being asked to test all newly diagnosed HIV cases for drug resistance and report them to the health department, Wood said. According to physicians, it is unlikely the drug-resistant HIV strain will cause the men to progress more rapidly to AIDS; however, once they do progress to the disease, treating them will be more difficult (Seattle Times, 2/2). Health officials as of last week had recorded 12 cases of multidrug-resistant HIV in the county, but none of the cases was as resistant to antiretrovirals as the most recent four, the AP/Chronicle reports (AP/Houston Chronicle, 2/2). About 350 to 400 new HIV cases are reported in King County annually, and about 8,000 county residents are living with the virus. Wood said the new cases should serve as an early warning because "they show there is some ongoing transmission" (Seattle Times, 2/2). Wood added, "This is mostly about behavior. Men who have sex with men need to know that drug-resistant strains can and are being transmitted and may be much less treatable" (Paulson, Seattle Post-Intelligencer, 2/2).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Bush FY 2008 Budget Proposal Would Allocate $5.4B For PEPFAR
President Bush on Monday released his $2.8 trillion fiscal year 2008 budget proposal, which would allocate $5.4 billion for the President's Emergency Plan for AIDS Relief, the Wall Street Journal reports (Phillips, Wall Street Journal, 2/6). Bush's budget proposal would allocate $4.2 billion for treatment, prevention and care initiatives to PEPFAR's 15 focus countries, as well as an additional $1.2 billion for global HIV/AIDS programs, disease research and contributions to partner organizations (President's FY 2008 budget, 2/5). Included in the PEPFAR budget, Bush has asked for $300 million for the Global Fund To Fight AIDS, Tuberculosis and Malaria and $491 million for other activities, including TB programs (PEPFAR.gov release, 2/2). In addition to the PEPFAR funding, the budget proposal would provide $300 million for the President's Malaria Initiative and ongoing malaria programs worldwide (President's FY 2008 budget, 2/5). The budget proposal also calls for $3 billion for the Millennium Challenge Corporation, a program meant to encourage economic and political reforms in developing countries, VOA News reports (VOA News, 2/5). Bush's budget proposal comes a week after the House voted 286-140 to approve a $463 billion spending resolution (HJ Res 20) for FY 2007 that includes a $1.3 billion increase for PEPFAR. The resolution would bring the total for PEPFAR to $4.5 billion and would allocate $724 million for the U.S. contribution to the Global Fund. In addition, $248 million would be allocated to expand programs under PMI, an increase of $149 million. The Senate is expected to consider the bill this week (Kaiser Daily HIV/AIDS Report, 2/2). "The Global fund will need $1.4 billion from the U.S., as well as added funding from the rest of the world," Friends of the Global Fight President Jack Valenti said, adding, "We are concerned that without additional funds, a lot of people will die. In the upcoming year, I look forward to working with the [Bush] administration and Congress to fully fund the Global Fund and the president's programs" (Friends of the Global Fight release, 2/5).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Chinese Authorities Prevent HIV/AIDS Advocate From Coming To U.S. To Accept Award
Chinese HIV/AIDS advocate and retired physician Gao Yaojie last week was put under house arrest by Chinese authorities to prevent her from visiting the U.S. next month to accept an award from the group Vital Voices Global Partnership, the New York Times reports (Yardley, New York Times, 2/6). According to Gao's friend and Beijing-based AIDS advocate Hu Jia, Chinese authorities from the eastern province Henan told Gao not to attend the Vital Voices awards ceremony, the AP/Washington Post reports. When Gao refused, she was put under house arrest to prevent her from traveling to Beijing to apply for a U.S. visa, Hu said. Gao's friends and family were blocked from visiting her or were questioned before being given permission to visit, and her daughter is under police surveillance, Hu said (Olesen, AP/Washington Post, 2/4). A spokesperson for the U.S. Embassy in Beijing said the embassy had "raised the issue [of Gao's house arrest] with the Chinese Ministry of Foreign Affairs" but did not give details, according to Reuters UK (Reuters UK, 2/5). Gao in the 1990s alerted people in Henan of HIV cases that occurred through tainted blood transfusions (AP/Washington Post, 2/4). Gao also distributed material warning people of HIV and the risks of donating blood, Reuters UK reports (Reuters UK, 2/5). In addition, Gao has distributed medicine to HIV-positive people, provided cared for AIDS orphans and hosted people living with HIV/AIDS in her home. She also has written a book about the HIV/AIDS epidemic in China, the AP/Post reports (AP/Washington Post, 2/4). Chinese authorities in 2001 and 2003 prevented Gao from traveling abroad to accept awards for her work, Reuters UK reports (Reuters UK, 2/5). "We would like to believe that this is a misunderstanding because Dr. Gao has been publicly recognized by the Chinese government many times," Wenchi Yu Perkins, Vital Voices' human rights program director, said, adding, "We are talking to our contacts in China to understand what is happening." Chinese Foreign Ministry spokesperson Jiang Yu on Tuesday said that she is not aware of Gao's situation. China is a "country ruled by law" that "protect[s] the rights of all citizens," she said, adding, "Nobody has the right to be above the law" (Olesen, AP/Forbes, 2/6).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Preclinical Results Of Geovax's AIDS Vaccines Demonstrate Potential To Protect Against Disease
GeoVax Labs, Inc. (OTC BB: GOVX), an Atlanta-based biotechnology company, have reported successful results from a preclinical trial using GeoVax's vaccines for the therapeutic treatment and prevention of Acquired Immunodeficiency Disease Syndrome ("AIDS") in non-human primates. The data demonstrate the effectiveness of GeoVax's DNA/MVA vaccines in controlling the Simian ("SIV") AIDS virus through immune responses raised by the vaccines. These promising results have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's vaccines.
In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines.
The reduction of virus levels in the blood stream of these AIDS virus-infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.
"The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS," said Don Hildebrand, CEO of GeoVax Labs. "Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines."
The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.
The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.
###
These studies were conducted at Emory University and were supported by funding from the National Institutes of Health.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
Contact: Melanie Nimrodi
Financial Relations Board
In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines.
The reduction of virus levels in the blood stream of these AIDS virus-infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.
"The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS," said Don Hildebrand, CEO of GeoVax Labs. "Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines."
The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.
The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.
###
These studies were conducted at Emory University and were supported by funding from the National Institutes of Health.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
Contact: Melanie Nimrodi
Financial Relations Board
AVAC Applauds Commencement Of First HIV Vaccine Efficacy Trial In Africa
The AIDS Vaccine Advocacy Coalition (AVAC) heralds today's launch of the first African efficacy trial of an experimental HIV vaccine as a critical, strategic and historically- significant step in the search for an AIDS vaccine.
The trial, which is known as Phambili (a Xhosa word meaning "moving forward") or HVTN 503, was launched today in South Africa by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN) of the US National Institutes of Health.
"South Africa and the partner agencies in this study are demonstrating tremendous leadership. With the stakes as high as they are in the epidemic, accelerating large-scale efficacy trials in the countries and communities that need an HIV vaccine the most is the kind of forward-looking, strategic decision-making that the field needs and should embrace," said Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC).
The same vaccine candidate, which has been developed by Merck Research Laboratories, is currently being tested in another efficacy trial being conducted in various sites in North and South America, the Caribbean and Australia. The data from this study, known as the Step Study, are not yet known. Phambili has been initiated before the conclusion of the Step Study to help speed the progress of gathering additional important data in sub-Saharan Africa.
"The timing of the Phambili trial launch is a bold decision," said Warren. "There is an urgent need to identify new AIDS prevention strategies as quickly as possible; this sequence of trials will help move the field forward as quickly as possible. These two trials will combine to shed light on whether this vaccine candidate has the potential to be a truly global vaccine that can eventually be used in both developed and developing countries."
"As this trial moves forward, AVAC also hopes that this vaccine candidate will also be studied among adolescents. Adolescents are at great risk of HIV infection, and AVAC strongly supports the inclusion of adolescents in future trials so that we can get answers as quickly as possible for this priority population," Warren said.
"Finding an effective AIDS vaccine will not happen in one isolated sector or country, but from international collaborations between industry, government agencies, academia, and public-private partnerships. Phambili is an excellent example of putting public funds to good use to test a promising vaccine candidate," Warren said.
While there have been a significant number of small and mid-size safety studies conducted in sub-Saharan Africa, Phambili is the first study that is designed to provide information on whether or not a vaccine protects against HIV infection or helps to blunt HIV disease. Neither the Step Study nor the Phambili trial has been designed as the final study of this vaccine candidate; if there are indications of efficacy, additional studies will be conducted to confirm this preliminary finding.
About AVAC: Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other prevention options. For more information, visit http://www.avac.org.
AIDS Vaccine Advocacy Coalition
http://www.avac.org
The trial, which is known as Phambili (a Xhosa word meaning "moving forward") or HVTN 503, was launched today in South Africa by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN) of the US National Institutes of Health.
"South Africa and the partner agencies in this study are demonstrating tremendous leadership. With the stakes as high as they are in the epidemic, accelerating large-scale efficacy trials in the countries and communities that need an HIV vaccine the most is the kind of forward-looking, strategic decision-making that the field needs and should embrace," said Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC).
The same vaccine candidate, which has been developed by Merck Research Laboratories, is currently being tested in another efficacy trial being conducted in various sites in North and South America, the Caribbean and Australia. The data from this study, known as the Step Study, are not yet known. Phambili has been initiated before the conclusion of the Step Study to help speed the progress of gathering additional important data in sub-Saharan Africa.
"The timing of the Phambili trial launch is a bold decision," said Warren. "There is an urgent need to identify new AIDS prevention strategies as quickly as possible; this sequence of trials will help move the field forward as quickly as possible. These two trials will combine to shed light on whether this vaccine candidate has the potential to be a truly global vaccine that can eventually be used in both developed and developing countries."
"As this trial moves forward, AVAC also hopes that this vaccine candidate will also be studied among adolescents. Adolescents are at great risk of HIV infection, and AVAC strongly supports the inclusion of adolescents in future trials so that we can get answers as quickly as possible for this priority population," Warren said.
"Finding an effective AIDS vaccine will not happen in one isolated sector or country, but from international collaborations between industry, government agencies, academia, and public-private partnerships. Phambili is an excellent example of putting public funds to good use to test a promising vaccine candidate," Warren said.
While there have been a significant number of small and mid-size safety studies conducted in sub-Saharan Africa, Phambili is the first study that is designed to provide information on whether or not a vaccine protects against HIV infection or helps to blunt HIV disease. Neither the Step Study nor the Phambili trial has been designed as the final study of this vaccine candidate; if there are indications of efficacy, additional studies will be conducted to confirm this preliminary finding.
About AVAC: Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other prevention options. For more information, visit http://www.avac.org.
AIDS Vaccine Advocacy Coalition
http://www.avac.org
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