Friday, January 30, 2009

The spectrum of kidney disease in patients with AIDS in the era of antiretroviral therapy


With prolonged survival and aging of the HIV-infected population in the era of antiretroviral therapy, biopsy series have found a broad spectrum of HIV-related and co-morbid kidney disease in these patients. Our study describes the variety of renal pathology found in a prospective cohort of antiretroviral-experienced patients (the Manhattan HIV Brain Bank) who had consented to postmortem organ donation.

Nearly one-third of 89 kidney tissue donors had chronic kidney disease, and evidence of some renal pathology was found in 75. The most common diagnoses were arterionephrosclerosis, HIV-associated nephropathy and glomerulonephritis. Other diagnoses included pyelonephritis, interstitial nephritis, diabetic nephropathy, fungal infection and amyloidosis.

Excluding 2 instances of acute tubular necrosis, slightly over one-third of the cases would have been predicted using current diagnostic criteria for chronic kidney disease. Based on semi-quantitative analysis of stored specimens, pre-mortem microalbuminuria testing could have identified an additional 12 cases.

Future studies are needed to evaluate the cost-effectiveness of more sensitive methods for defining chronic kidney disease, in order to identify HIV-infected patients with early kidney disease who may benefit from antiretroviral therapy and other interventions known to delay disease progression and prevent complications.

Heterosexual risk of HIV-1 infection per sexual act


Thelancet did a systematic review and meta-analysis of observational studies of the risk of HIV-1 transmission per heterosexual contact.

43 publications comprising 25 different study populations were identified. Pooled female-to-male (0·04% per act [95% CI 0·01—0·14]) and male-to-female (0·08% per act [95% CI 0·06—0·11]) transmission estimates in high-income countries indicated a low risk of infection in the absence of antiretrovirals.

Low-income country female-to-male (0·38% per act [95% CI 0·13—1·10]) and male-to-female (0·30% per act [95% CI 0·14—0·63]) estimates in the absence of commercial sex exposure (CSE) were higher. In meta-regression analysis, the infectivity across estimates in the absence of CSE was significantly associated with sex, setting, the interaction between setting and sex, and antenatal HIV prevalence.

The pooled receptive anal intercourse estimate was much higher (1·7% per act [95% CI 0·3—8·9]). Estimates for the early and late phases of HIV infection were 9·2 (95% CI 4·5—18·8) and 7·3 (95% CI 4·5—11·9) times larger, respectively, than for the asymptomatic phase. After adjusting for CSE, presence or history of genital ulcers in either couple member increased per-act infectivity 5·3 (95% CI 1·4—19·5) times versus no sexually transmitted infection. Study estimates among non-circumcised men were at least twice those among circumcised men. Low-income country estimates were more heterogeneous than high-income country estimates, which indicates poorer study quality, greater heterogeneity of risk factors, or under-reporting of high-risk behaviour.

Efforts are needed to better understand these differences and to quantify infectivity in low-income countries.

Use of Saliva as a Lubricant in Anal Sexual Practices Among Homosexual Men

Objectives: Compared with other sexually active adults, men who have sex with men (MSM) are more frequently infected with several pathogens including cytomegalovirus, hepatitis B virus, and Kaposi sarcoma-associated herpesvirus. Because one common element between these organisms is their presence in saliva, we evaluated saliva exposure among MSM in a heretofore relatively unrecognized route-via use of saliva as a lubricant in anal sex.

Methods: MSM in a San Francisco population-based cohort were interviewed regarding use of saliva by the insertive partner as a lubricant in various anal sexual practices.

Results: Among 283 MSM, 87% used saliva as a lubricant in insertive or receptive penile-anal intercourse or fingering/fisting at some point during their lifetime; 31%-47% did so, depending upon the act, in the prior 6 months. Saliva use as a lubricant was more common among younger men and among HIV-infected men when with HIV-infected partners. Even among MSM following safe sex guidelines by avoiding unprotected penile-anal intercourse, 26% had anal exposure to saliva via use as a lubricant.

Conclusions: Among MSM, use of saliva as a lubricant is a common, but not ubiquitous, practice in anal sex. The findings provide the rationale for formal investigation of whether saliva use in this way contributes to transmission of saliva-borne pathogens in MSM.

Short-Term and Long-Term Effects of Highly Active Antiretroviral Therapy on the Incidence of Herpes Zoster in HIV-Infected Children

Levin, Myron J MD*; Anderson, Jeffrey P MPH†‡; Seage, George R III ScD†‡; Williams, Paige L PhD†§; for the PACTG/IMPAACT 219C Team

From the *Department of Pediatrics, University of Colorado at Denver Health Sciences Center, Aurora, CO; †Center for Biostatistics in AIDS Research; ‡Department of Epidemiology; and §Department of Biostatistics, Harvard School of Public Health, Boston, MA.

Received for publication July 1, 2008; accepted November 14, 2008.

Supported by funding from the Statistical and Data Analysis Center at Harvard School of Public Health, under the National Institute of Allergy and Infectious Diseases cooperative agreement #5 U01 AI41110 with the Pediatric AIDS Clinical Trials Group and #1 U01 AI068616 with the International Maternal Pediatric Adolescent AIDS Clinical Trials Group. Overall support for International Maternal Pediatric Adolescent AIDS Clinical Trials was provided by the National Institute of Allergy and Infectious Diseases [U01 AI068632] and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

A portion of this analysis was presented at the 13th Conference on Retroviruses and Opportunistic Infections, February 5-8, 2006, Denver, CO.

All of the authors made substantial contributions to the conception, design, acquisition of data, and analysis and interpretation of data for this article; contributed substantially to the drafting and revision of this article; and have given final approval for submission of this article.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health.

Background: Highly active antiretroviral therapy (HAART) has reduced herpes zoster (HZ) incidence in HIV-infected children, yet it remains common.

Methods: We evaluated perinatally HIV-infected youth with varicella infection enrolled between 1993 and 2006 in a prospective cohort study. Incidence rates (IRs) and 95% confidence intervals of HZ were estimated by calendar year, age group, and HAART use. The effect of initiating HAART was also evaluated by fitting Cox survival models adjusted for potential confounders.

Results: Among 536 perinatally infected children with documented prior varicella (median follow-up = 6.8 years), 116 (22%) developed HZ (IR = 3.2 events/100 person-years, confidence interval: 2.6 to 3.8). IRs increased from 1993 to 1996 and then declined significantly through 2006 (P <>

Conclusions: Although HAART has markedly reduced the IR of HZ, it remains a frequent complication in HIV-infected children. The risk of HZ is similar in the 90 days before and after initiating HAART.



Thursday, January 22, 2009

Monitoring AIDS Treatment By Physical Symptoms Is Effective

When millions of HIV-infected people in poor countries began receiving advanced drug therapies, critics worried that patient care would suffer because few high-tech laboratories were available to guide treatments.

But according to a study being published in The Lancet, these concerns are as yet unfounded.
In fact, the study indicates that when clinicians use simple physical signs of deteriorating health - such as weight loss or fever - these doctors can provide therapies almost as effective as those relying on the most advanced laboratory analysis.

"The results of this study should reassure clinicians in Africa and Asia, who are treating literally millions of people without these laboratory tests, that they are not compromising patient safety," said a coauthor of the paper, Dr Charles Gilks, who is the Coordinator of Antiretroviral Treatment (ART) and HIV Care at WHO in Geneva. "In fact, the outcome of their treatment is almost as good as of those patients in the USA and Europe where laboratory-guided treatment is the norm."

The aim of the study was to look at the medium and long-term consequences of different approaches to monitoring antiretroviral therapy in a resource-limited setting: using clinical signs and symptoms alone as recommended in WHO guidelines; or more sophisticated and costly but far less accessible immunological and virological load tests. The scientists used a model that had been tried and tested in London, and shown accurately to predict the course of the epidemic in the UK over 20 years, but with various changes to reflect realities on the ground.

According to the study authors, survival rates for individuals assessed for clinical symptoms alone were almost identical to survival rates for those who underwent laboratory monitoring. The 5-year survival rate was 83% for individuals monitored for viral load, 82% for CD4 (a critical immune component) monitoring, and 82% for clinical monitoring alone. Corresponding values over a 24-year period were 67%, 64% and 64% respectively.

Although the survival rate was slightly higher with viral load monitoring, study authors pointed out it was not the most cost-effective strategy in the poorest countries. The study also examined whether clinical observation alone was effective in determining when to switch patients from WHO-recommended first-line treatments to more costly second-line medicines. Again, diagnosis based on an assessment of clinical symptoms was almost as effective as those relying on expensive laboratory tests.

Study authors concluded that for patients on the WHO first-line regimen of stavudine, lamivudine and nevirapine, the benefits of CD4 count or viral load monitoring were only modest at best.

The study, conducted by a prominent group in the United Kingdom working with WHO scientists, employed mathematical models which were designed to identify emerging problems and problems that might appear after long-term use of ART. But more work must be done. The study is based on mathematical projections and not on real-world patients. While there is little real-world data yet available because these drugs have been used for such a short time in these countries, the little existing information does support the findings. Other studies are ongoing and more results should be available soon.

Monkeys Able To Fend Off AIDS Like Symptoms With Enhanced HIV Vaccine

Researchers at the University of Pennsylvania School of Medicine have discovered that using an immune system gene to enhance a vaccine used to study HIV in macaque monkeys provides the animals with greater protection against simian HIV (SHIV) than an unmodified vaccine. This multi-year study found that the addition of a molecule called Interleukin-15 effectively boosts the effects of a vaccine derived from the DNA of simian HIV. The study illustrates that DNA vaccine effectiveness can be improved by the inclusion of specific immune adjuvants, or helpers.

The findings are published in last week's online edition of the Proceedings of the National Academy of Sciences.

"DNA vaccine technology has great promise for the development of vaccines and immune therapeutics for a variety of infectious diseases and cancers," says senior author David B. Weiner, PhD, Professor of Pathology and Laboratory Medicine at Penn. While previous studies have established that the technology can induce immune responses safely, "improving the immune potency of this platform is critical for further development in humans."

The research builds on previous work aimed at engineering a more potent immune response to SHIV DNA vaccine technology. Mouse model studies previously showed that the cytokine IL-15 -- a substance that can improve the body's natural response to infection and disease -- helps better immune responses and protection, while this study mirrors those findings in a larger, non-human primate species.

In this study, the group of macaques that was injected with the vaccine containing a loop of DNA enabling them to make IL-15 developed no signs of AIDS-like symptoms when exposed to live SHIV, compared to four animals in the control group that received only the DNA vaccine. The modified vaccine appeared to help suppress viral replication among the IL-15 group.

Next, Weiner's team will study the protected macaques to determine the actual mechanism of their protection, and seek out any pockets of the virus that may be hiding in specific immune compartments. The approach will also be tested for safety and immunogenicity in humans through the HIV Vaccine Trials Network.

The lead author of the study is Dr. Jean Boyer, of the University of Pennsylvania. Co-authors include researchers from the National Cancer Institute, the Southern Research Institute in Frederick, MD, the National Institute of Allergy and Infectious Diseases in Bethesda, MD, Genomix (San Diego, CA) and Wyeth (Pearl River, N.Y.). The research was supported by the National Institutes of Health and the Intramural Research Program of the NIH.

PENN Medicine is a $3.5 billion enterprise dedicated to the related missions of medical education, biomedical research, and excellence in patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System.

Penn's School of Medicine is currently ranked #3 in the nation in U.S.News & World Report's survey of top research-oriented medical schools; and, according to most recent data from the National Institutes of Health, received over $379 million in NIH research funds in the 2006 fiscal year. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.

The University of Pennsylvania Health System includes three hospitals its flagship hospital, the Hospital of the University of Pennsylvania, rated one of the nation's "Honor Roll" hospitals by U.S.News & World Report; Pennsylvania Hospital, the nation's first hospital; and Penn Presbyterian Medical Center a faculty practice plan; a primary-care provider network; two multispecialty satellite facilities; and home care and hospice.

Wednesday, January 21, 2009

HIV/AIDS Advocates Protest Novartis' Case Challenge India Patent Law

Some HIV/AIDS advocacy groups are calling on pharmaceutical company Novartis to drop its legal challenge to the Indian government's patent laws, saying that if the company wins the case it could restrict access to anti retroviral drugs for millions of people worldwide, South Africa's Business Day reports.

Novartis is challenging a section of India's Patents Act that aims to restrict certain kinds of patents, according to Business Day. Novartis brought a civil lawsuit against the Indian government after the country in January 2006 rejected the company's attempt to patent a new version of its leukemia drug Gleevec on the basis that the drug is a new formulation of an existing drug (Musgrave, Business Day, 1/25). According to the AP/International Herald Tribune, India's patent law, which went into effect in January 2005, allows patents for products that are new inventions developed after 1995, when India joined the World Trade Organization, or for an updated drug that exhibits improved efficacy. Although some Indian drug companies and groups say that Gleevec is a new formulation of a drug developed before 1995, Novartis says that it is an improved drug (Rabinowitz, AP/International Herald Tribune, 1/29).

Decisions concerning patents on some newer HIV/AIDS drugs in India have not been announced (Business Day, 1/25). If Novartis wins the case, it could potentially set a precedent for other pharmaceutical companies seeking patent protection for drugs, including anti retrovirals, some HIV/AIDS advocates have said (AP/International Herald Tribune, 1/29).

Medecins San Frontieres International Council President Christophe Fournier last month said the organization relies on reduced-cost, quality drugs produced in India to provide treatment to people living with HIV/AIDS worldwide.
According to the group, anti retrovirals produced in India are used to provide treatment to more than 80% of the 80,000 people in more than 30 countries who receive treatment from the organization's projects (Business Day, 1/25). A court in Chennai, India, heard arguments in the case on Monday (AP/International Herald Tribune, 1/29).
According to the New York Times, the court was asked to clarify regulations on patents for new versions of existing drugs whose original patents have expired. Novartis spokesperson John Gilardi said, "We are trying to gain clarity as to what guides India's patent laws. ... This is not about access to medicines.

It is about establishing whether India is going to step up and adopt the minimum international standards required for the protection of intellectual property." Unni Karunakara, medical director of MSF's campaign to broaden access to medicines, said, "Novartis is trying to shut down the pharmacy of the developing world." A decision in the Novartis case is not expected until Feb. 15 (Gentleman, New York Times, 1/30).

Obama, McCain Silent On HIV/AIDS Epidemic Facing The Black Community

The HIV/AIDS "plague has long been the single biggest health issue in poor black communities" in the U.S., which is "all the more reason" for presumptive presidential nominees Sens. Barack Obama (D-Ill.) and John McCain (R-Ariz.) to "speak out on the crisis and spell out just what they will do about it," Earl Ofari Hutchinson, author and political analyst, writes in a New America Media opinion piece, adding, "So far they haven't done that." He writes that the candidates "have given countless speeches on the terrorism fight, the Iraq War, the Iran missile threat, immigration, the housing and banking crisis, a tanking economy and affordable health care," which are "crucial problems" facing the U.S. However, "as devastating as these problems are to many families, they do not pile up bodies and wreak catastrophic havoc on entire sectors of the population, mostly poor black communities" like the HIV/AIDS epidemic does, according to Hutchinson.

"HIV/AIDS is not even mentioned as an item in the detailed health care plan on" McCain's official Web site. Obama and his wife publicly took HIV tests last year, and he subsequently offered a pledge to create a national strategy on AIDS. However, he "hasn't publicly addressed the issue since," Hutchinson writes, noting, "In a campaign position paper Obama has said he will push for more funds for AIDS treatment, education and testing. But much of his emphasis has been on African nations." Hutchinson writes that "even if McCain had boned up on the AIDS crisis and laid out a plan to confront the crisis, and Obama had fleshed out more details about confronting the crisis in African-American communities, it's still no substitute for speaking out on the campaign trail about the crisis and pushing government, health agencies and private donors to do more to combat the AIDS plague."

He concludes that both candidates "should break their silence now" (Hutchinson, New America Media, 8/1).

At 23 Sept 2006 Was registered some efforts In The Fight Against AIDS In Ukraine Joined By Clinton Foundation

President Bill Clinton and two Ukrainian foundations, headed by Elena Franchuk and Victor Pinchuk, signed an agreement of cooperation today that will expand the work against HIV/AIDS in Ukraine.

Under the agreement Ukraine will receive access to the best practices to fight epidemics and the latest know-how in the area of HIV/AIDS prevention, treatment and care. The Elena Franchuk ANTIAIDS foundation will cooperate with Clinton HIV/AIDS Initiative for the next five years in implementing project aimed at reducing HIV/AIDS escalation, care and support of people living with HIV/AIDS in Ukraine. Elena Franchuk and Victor Pinchuk are contributing US$2.5 million toward the project.

The funds will be used during the next five years to pay for programs aimed at slowing the growth of new HIV/AIDS cases, as well as for treatment and support of people living with HIV/AIDS in Ukraine.

"I'm happy to be working with the Elena Franchuk ANTIAIDS Foundation and the Victor Pinchuk Foundation on expanding access to HIV/AIDS prevention, care and treatment services in Ukraine," President Clinton said. "Through their generous support, we will be able to greatly increase the number of people with access to these services, and I am grateful for the partnership."

"The work of Clinton Foundation made tremendous difference in treatment and care of people living with HIV/AIDS in many countries. I am sure that Ukraine will benefit from President Clinton's expertise," Elena Franchuk said. "For the ANTIAIDS Foundation this partnership means an expansion of our activities, which have been centered for the last three years on media campaigns. Now, to change the AIDS situation in Ukraine, the country needs the best international experience and know-how in combating the epidemics."

Work during the first year of the project will be centered on the Dnepropetrovsk region, in the southeast part of Ukraine, which is home to more than 3 million people. The program's initiatives will be replicated in other regions of Ukraine in following years.

Specifically, the programs will work to increase access to rapid testing, improve laboratory capacity, train and mentor health care workers, introduce HIV treatment/substitution therapy and to improve drug procurement processes. The program will also work nationally in Ukraine to expand HIV testing legislation, develop rapid HIV test guidelines, register methadone for use and improve distribution and drug procurement processes and prices.

The agreement is the result of discussions started in 2004, when representatives of The Clinton Foundation visited Ukraine at the invitation of Ms. Franchuk. Following that visit an agreement between the Clinton Foundation and the government of Ukraine was signed, which assisted the government in receiving access to the lowest prices on generic antiretroviral drugs for HIV/AIDS treatment. The agreement allowed more patients in Ukraine to receive access to live-saving therapy as part of the Global Fund to Fight AIDS, TB and Malaria grant.

The work continued in 2005 during President Clinton's visit to Ukraine, with the signing of a memorandum which identified priority directions of cooperation of Clinton Foundation and the Government of Ukraine in the fight against HIV/AIDS. The five year program resulted from that memorandum. The Elena Franchuk "ANTIAIDS" Foundation and the Victor Pinchuk Foundation expressed their readiness to join efforts in the implementation of this project and committed the US$2.5 million.

Former U.N. Special Envoy For HIV/AIDS In Africa Lewis Calls On Canada To Commit $855M To Global Fund

Stephen Lewis, former United Nations special envoy for HIV/AIDS in Africa, on Friday at a press conference called on the Canadian government to commit 900 million Canadian dollars, or about $855 million, during the next three years to the Global Fund To Fight AIDS, Tuberculosis and Malaria, the Toronto Star reports. Lewis also called on Canada's leaders to increase foreign aid contributions as part of the country's membership in the Group of Eight industrialized nations (Black, Toronto Star, 8/11).

Lewis at the press conference said that Canada is decreasing its financial aid commitments aimed at fighting HIV/AIDS in developing countries. Lewis said Canada is "going in reverse" in funding commitments, adding, "It's just delinquency to fall further behind" (CanWest/Calgary Herald, 8/11).

In addition, Lewis at the press conference released the results of a Canadian Coalition for Youth and HIV/AIDS in Africa poll. The poll found that 46% of respondents believe it is "very" important for the government to increase access to treatment for people living with HIV/AIDS in developing countries, while 45% found it "somewhat" important. The coalition - which includes Canadian chapters of CARE, Plan, Save the Children and World Vision - also called on the government to increase funding to fight HIV in developing countries.

According to the poll, nine out of 10 respondents believe HIV/AIDS is a serious problem, and 62% believe it is an international emergency. In addition, 48% of survey participants said the government is spending too little to fight HIV/AIDS in developing countries. Ninety percent of participants said Africa is the most vulnerable area worldwide to HIV/AIDS, and 92% understood that the continent is the hardest hit by the spread of the virus.

The poll also found that 70% of respondents believed they are well-informed about HIV/AIDS, compared with 80% in 2005. The poll was based on a sample of 1,429 adults and has a margin of error of plus or minus 2.6 percentage points, the Star reports (Toronto Star, 8/11).

Thai HIV/AIDS Advocates To Ask Administrative Court For Review Of Ruling That Found Abbott Did Not Violate Trade Laws

HIV/AIDS advocates in Thailand plan to ask the country's Administrative Court to evaluate an Internal Trade Department's decision to not file suit against Abbott Laboratories for allegedly violating trade laws when the company canceled the registration of its anti retro viral Aluvia with the country's Food and Drug Administration, the Bangkok Post reports (Apiradee, Bangkok Post, 1/18).

The Thai government in January 2007 issued a compulsory license to produce a lower-cost version of Abbott's anti re trivial Kaletra. The drug company in May 2007 offered to sell Aluvia, an updated version of Kaletra, at a reduced price in Thailand on the condition that the country agree not to allow generic versions of the drug into the market, Siriwat Thiptaradol, secretary-general of the Thai FDA, said. The Thai Ministry of Public Health in June 2007 confirmed that it would continue with its plan to issue a compulsory license for the drug after Abbott and the health ministry could not reach a price agreement during negotiations. Thailand's FDA in October 2007 completed the registration of a generic version of Aluvia for use under the country's compulsory licensing program. The generic version is manufactured by the Indian generic pharmaceutical company Matrix Laboratories .

According to HIV/AIDS advocates, Abbott canceled registration of Aluvia in Thailand after the government issued a compulsory license for the drug. Advocates have said the move violated section 25 of the country's Trade Competition Act, which stipulates restrictions against a product being dominant in the market.

In addition, the advocates said that the canceled registration violated section 28 of the trade act, which places controls on parent companies' influence on subsidiaries' decisions, the Post reports.

Advocates later petitioned a trade competition panel at the Ministry of Commerce to look into the matter. The panel in late December 2007 ruled that Abbott's withdrawal of Aluvia's registration did not violate trade regulations.
Panel secretary Yanyong Phuangrach said the body determined the market value of Aluvia was too small to dominant the market and thus did not violate trade law.

Saree Ongsomwang - manager of the Foundation for Consumers, which petitioned the ministry panel to examine the issue - said advocates would ask the Administrative Court to review the panel's decision. Nimit Tienudom, chair of the AIDS Access Foundation, petitioned the panel to reveal additional details about its decision. He also proposed that a new panel of neutral academics be convened to examine the issue. Saree said she was "surprised by the panel's decision," adding, "They should have prioritized health problems caused by HIV/AIDS and consider essential lifesaving drugs as a special case rather than protecting the benefits of big pharmaceutical business" (Bangkok Post, 1/18).

GeoVax Reports Progress On Its AIDS Vaccine Technology

GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta based, publicly traded biopharmaceutical company specializing in the prevention and treatment of infectious diseases, provided an operational update on the company's progress towards entering Phase 2 preventative human clinical trial testing and plans to proceed into therapeutic human trials with its AIDS vaccine.

Five successful human trials evaluating GeoVax AIDS vaccines have previously been reported.

Planned Phase 2 Human Clinical Trial for Prevention of AIDS

The Company's Phase 2 trial, conducted by the U.S. National Institutes of Health (NIH) supported HIV Vaccine Trials Network (HVTN), will involve 225 healthy volunteers from the United States and South America, and will further evaluate the safety and immunogenicity of the GeoVax preventative vaccine (vaccine administered prior to infection with the HIV virus). In Phase 1 trials, both 1/10th dose and full dose of the GeoVax vaccine elicited anti-HIV T-cells, whereas the full dose was required to elicit good frequencies of antibody to the HIV Envelope glycoprotein. The larger Phase 2 human trial will broaden the base of safety and immunogenicity data for the full dose of the GeoVax AIDS vaccine with a view to protecting recipients from developing AIDS should they be exposed to the virus. The planned Phase 2 human clinical trial is currently scheduled to start early this fall, subject to FDA approval.

Preclinical Data for Use of Vaccine Technology as an AIDS Therapeutic Human Clinical Trials in Planning Stages GeoVax also announced summary data from a pilot study on therapeutic vaccination in simian immunodeficiency virus (SIV) infected non-human primates with the SIV prototype for the GeoVax AIDS vaccine. In this small pilot study, conducted by Dr. Amara at Emory University, two non-human primates were infected with SIV. At 12 weeks post SIV infection, conventional anti-viral drug therapy was given to the primates to reduce the viral RNA infection levels to very low levels creating a non progressor status for the primate. Then the SIV prototype vaccine for the GeoVax AIDS vaccine was administered. Six weeks following the final vaccination, anti-viral drug treatment was stopped and the animals were monitored to determine whether the vaccine could control the SIV infection during the absence of the drugs.

The outstanding results from the study revealed the vaccine controlling the infection in the absence of drugs. In one primate, the reduction in viral levels over pre-drug treatment and vaccination levels was 1000 times. In the other, the reductions in viral levels were 100 times. The excellent control of the virus infection in the absence of drug treatment was associated with the vaccine raising the types of CD4 and CD8 T cells that are found in the rare individuals who spontaneously control their HIV infections.

Based on these excellent results, planning for a therapeutic trial in infected and drug treated humans has been initiated. The intent of therapeutic vaccination is for the vaccine to "control" HIV virus levels in infected individuals to very low levels thus blocking the development of AIDS. Successful therapeutic AIDS vaccination programs with GeoVax vaccines would lead to reduction in the use of costly anti-HIV medications and their often harmful side effects.

Dr. Harriet Robinson, GeoVax Co-founder and Senior V.P. of Research and Development, commented, "I had not anticipated the extent of vaccine control that was achieved in the already infected non-human primates. These are highly promising results that need to be extended into infected humans to see if the vaccine can be used to reduce the need for taking drugs. The results also warrant more extended studies in already infected non-human primates to explore parameters that both limit and enhance the ability for a vaccine to displace the need for drugs."

Dr. Robert McNally, CEO and President of GeoVax Labs, Inc., emphasized, "It is noteworthy to mention that the GeoVax AIDS vaccines being tested in the preclinical therapeutic trial is the same basic vaccine administered in the Company's human trials testing for a preventative use of the vaccine, vaccinating people before infection to prevent the development of AIDS should they become infected. Thus, a "one for two" vaccine could be a breakthrough solution for the company and the world, saving millions of dollars in redundant development costs and years of testing time by utilizing safety data already achieved in Phase 1 preventative human trials. More important, time to market could be significantly reduced, saving lives much sooner than otherwise."

Further, GeoVax's management is pleased to report that the company is currently engaged in negotiations with a NIH sponsored trial network to administer, conduct and co-sponsor GeoVax's Therapeutic human trial program. Management expects to receive approval for undertaking formal protocol development in the near future and will report more detailed plans accordingly.

"From an operational standpoint, we are very pleased with the overall progress of the company," stated Dr. Robert McNally. "Progress with ongoing preventative vaccine trials and now the potential to address therapeutic use of the vaccine gives GeoVax an expanding role in the fight to control AIDS."

About GeoVax Labs, Inc.

GeoVax Labs, Inc. is a biotechnology company, established to develop, manufacture, license and commercialize human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents. GeoVax's AIDS vaccine technology is the subject of 20 issued or filed patent applications. GeoVax AIDS vaccines are designed for use in uninfected people to prevent Acquired Immunodeficiency Disease (AIDS), caused by the virus known as HIV-1, should the person ever become infected. GeoVax AIDS vaccines also may be effective as therapeutics, treatment of people already infected with AIDS virus.

GeoVax's core AIDS vaccine technologies were developed by Dr. Harriet Robinson, Senior V.P. of Research and Development, through a collaboration of colleagues at Emory University's Vaccine Center, the National Institutes of Health (NIH), The Centers for Disease Control and Prevention (CDC) and GeoVax.

GeoVax AIDS vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials Network (HVTN) based in Seattle, Washington. The HVTN, funded through a cooperative agreement with the National Institutes of Health (NIH), is the largest worldwide clinical trials program dedicated to the development and testing of AIDS vaccines. Preclinical work enabling evaluation of GeoVax DNA and MVA vaccines was funded and supported by NIAID, which provided additional support to GeoVax AIDS vaccine development program with a $15 million IPCAVD grant awarded in late 2007.

Safe Harbor Statement: All statements in this news release, not statements of historical fact, are forward-looking statements. These statements are based on expectations and assumptions on 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. Risks and uncertainties include, but are not limited to, whether: GeoVax can develop and manufacture these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent AIDS in humans, vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, 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 limitation, risks detailed in the Company's Securities and Exchange Commission filings and reports.