Press Release

Study of Microbicide Gel Shows Reduced Risk of HIV & Herpes Infections in Women

“This is a historic day for HIV prevention research. The CAPRISA 004 results are the first clinical evidence that a microbicide gel can help to prevent sexual transmission of HIV infection,” said AVAC Executive Director Mitchell Warren, reacting to the results of the landmark microbicide trial presented today at the International AIDS Conference in Vienna.

“We believe that the most responsible plan of action now is to quickly and efficiently articulate the sequence of steps necessary for confirmation and follow-up of these results, while also aggressively planning for potential roll-out of a licensable product.”

“It will take time and resources to fully analyze and understand the data, but this proof of concept demands immediate action both in South Africa where there are a range of key, context-specific issues—and on a global level where this new evidence will energize and redirect the microbicide field as well as the broader arena of prevention strategies based on anti-HIV drugs. Simultaneous efforts on many fronts are needed to eventually realize the public health potential suggested by these data.”

“We congratulate the trial sponsors, scientific collaborators, and partners who conducted this trial, and especially want to thank the nearly 900 South African women whose altruism and commitment as trial volunteers made this effort possible. These volunteers and their communities have made an inestimable contribution to HIV prevention research and to the eventual development of new ways for women and men all over the world to protect themselves from HIV. We owe them an enormous debt of gratitude,” Warren said.

“As we move forward in our search for microbicides and other new HIV prevention options, researchers will need the collaboration of tens of thousands more men and women around the world in additional trials. Right now, the VOICE trial is working in four countries, including South Africa, to evaluate both 1% tenofovir gel and oral pre-exposure prophylaxis—this study is more important than ever, as are additional trials that have yet to be planned.”

As the trial team reported in Vienna today, CAPRISA 004 provided the first evidence that the use of the antiretroviral (ARV) drug tenofovir in the form of a vaginal gel can reduce the risk of HIV infection in women. The overall rate of effectiveness reported in the trial was 39 percent. The “test of concept” trial tested the effectiveness of 1% tenofovir gel, used before and after sex, among urban and rural South African women at high risk of HIV via vaginal sex.

“These results move us one step closer to finding much needed new HIV prevention options for women and men,” said Warren. “We look forward to working with the field to further examine the great wealth of data this trial has produced. These data will help guide decisions about further studies needed as well as provide important information to help design implementation programs if additional research indicates that we have a licensable product.”

AVAC calls on the trial sponsors, researchers, funders and others in the field to work quickly, and cooperatively to boldly to translate these findings into development of a scientific action plan to attempt to confirm these results and answer other outstanding questions. Such a plan must be well resourced and swiftly implemented, and it must ensure that additional supplies of tenofovir gel can be quickly manufactured to meet the needs of follow-up studies.

“As exciting as this result is—and as important as it is to follow it up without delay—the reality is that this product will not be available for widespread introduction tomorrow. Its critical to manage expectations while maintaining urgency. This challenging but necessary work falls on the shoulders of all stakeholders involved in AIDS prevention and treatment. At the same time, we must ensure that all stakeholders reaffirm their commitments to work that will lead to eventual access to effective microbicides for everyone who needs them,” Warren said.

Additional relevant information will also come from the ongoing research on other, related antiretroviral-based prevention strategies in HIV negative people. These include trials of pre- exposure prophylaxis, or PrEP, which is evaluating the use of oral ARVs to reduce HIV risk in HIV negative people. There is also one other ongoing effectiveness trial known as MTN 003, or VOICE, that is evaluating daily use of 1% tenofovir gel (a different dosing strategy from CAPRISA 004) along with oral use of tenofovir or tenofovir/emtricitabine. The positive finding from CAPRISA 004 increases hope that there will be benefit in some of these other trials—but it is no guarantee. Ongoing and additional research is needed to clarify the full potential of ARV-based prevention.

“This is an astonishing scientific achievement and a great boost to the microbicide field. At the same time, the results are complicated, and we will need to work hard to make sure that women and their partners understand what these results do and do not mean for the immediate future and in the long-term,” said Warren. “We are committed to working with communities to understand the results and the next steps.”

“The CAPRISA 004 results add immensely to the drive for a comprehensive response to HIV,” Warren added. “That means ensuring access for all who need it to existing HIV prevention and treatment options, including male and female condoms, behavior change counseling, male circumcision, clean needles, harm reduction and antiretroviral drugs; ensuring continued research to find effective new options, including microbicides, PrEP and vaccines; and planning for integrating these new interventions into combination programs.”

CAPRISA 004 was led by the Centre for the AIDS Programme of Research in South Africa (CAPRISA) at the University of KwaZulu-Natal and FHI and CONRAD in the US, and sponsored by the US Agency for International Development (USAID) and TIA, a biotechnology agency of the South African government’s Department of Science and Technology.

An AVAC report, A Cascade of Hope and Questions: Anticipating the results of upcoming ARV-based prevention trials and additional information about CAPRISA 004 and other upcoming results are available online at center;”>###

Press Release

Turning the Page to a New Era in HIV Prevention Research: AVAC Report warns promising developments in biomedical HIV prevention could be undermined by current conditions of the global AIDS response

New York, NY, 14 July 2010 – A new report from AVAC surveys the state of biomedical HIV prevention research, including the first evidence of vaccine-induced protection in humans and the emergence of ARV-based prevention—and provides strategic recommendations for moving forward in a time of constrained resources and faltering commitment to ending AIDS.

Turning the Page, AVAC’s 13th annual report on the state of the HIV prevention research field, offers unique context and a timely critique for issues that will be center stage at the upcoming AIDS 2010 Conference in Vienna. These issues are also central to the AIDS response outlined in the first ever US National HIV/AIDS Strategy, released Tuesday.

As the report describes, scientific developments in several arenas of biomedical prevention research have re-energized the search for additional strategies. In the vaccine field this includes the first evidence of vaccine-induced protection and strides in identification of new potent, HIV-specific neutralizing antibodies. Antiretroviral-based prevention also shows potential, and the report provides context for the upcoming results of the CAPRISA 004 microbicide trial, the first effectiveness trial of an ARV-based prevention strategy in HIV-negative people.

The biomedical prevention research field must now develop strategies for pursuing new scientific leads and following through on promising developments without the guarantee of expanded financial resources. In addition, the implications of recent breakthroughs need to be explained clearly to diverse audiences. As the report describes, the next phase of human clinical trials will involve complex designs and questions, and their success will depend on the support of all stakeholder groups. It will be difficult to execute this ambitious research agenda in the context of fiscal constraint—and the field needs to address this head on.

“We face yawning gaps in funding for proven prevention and treatment and a crisis in financial and political will,” said Mitchell Warren, AVAC Executive Director. “There is skepticism about whether disease-specific funding for AIDS is cost effective and skepticism about whether limited funds for AIDS should include funding for AIDS prevention research.”

“The recent report from UNAIDS that proven HIV prevention is having a demonstrable impact on the epidemic in many African countries is good news. But to really have an impact on the epidemic we need additional funding and political commitments for AIDS treatment and prevention programs AND more funding for HIV prevention research,” Warren added.

“The AVAC Report makes the critical point that to capitalize on recent breakthroughs in HIV prevention, we must find smart and innovative ways to make the best use of available funding,” said Chris Collins, AVAC Board Member and Vice President and Director, Public Policy at amfAR, The Foundation for AIDS Research.

The HIV prevention research field has been buoyed by major breakthroughs in recent months and Turning the Page calls for researchers, funders and others to prioritize collaboration and nimble and adaptive planning for replenishing the pipeline with new products and designing clinical trials that will yield the most information to move the field forward.

In recent years, the HIV prevention research agenda has broadened beyond vaccines and microbicides to include antiretroviral-based prevention, including pre-exposure prophylaxis, and, more recently, efforts to understand the role of treatment as prevention. At the same time, HIV treatment programs—once thought to be impossible to implement in developing countries—have expanded to reach millions of people around the world.

“The HIV prevention research agenda must take into account the new realities of the fight against AIDS. We believe that new prevention programs cannot be built while current treatment programs are faltering,” Warren said. “To reach the goal of universal access to healthcare—which includes comprehensive AIDS treatment and prevention—advocates, researchers, health care providers, funders and policy makers must speak with one voice.”

Turning the Page lays out the critical components of a response to AIDS that unites treatment and prevention, including:

Sustain and expand current treatment and care programs: Funding restrictions are beginning to take a damaging toll on AIDS treatment programs at the precise moment that data are emerging to show that ARV treatment prevents deaths, lowers health care costs and can reduce the risk of HIV transmission. Donors and policy makers must take the critical steps needed to forestall further damage and put treatment programs back on track.
Actively explore treatment as prevention: There is compelling evidence that earlier initiation of antiretrovirals in HIV-positive people can reduce the risk that they will infect sexual partners with HIV. Additional data will come from an ongoing clinical trial, but the world should begin exploring the practical approaches and implications of scaling up HIV treatment as prevention that can help guide policy makers’ decision-making about potential introduction of treatment as prevention when the data become available.
Plan for ARV-based prevention: Neither oral PrEP nor topical ARV-based microbicides have yet been proven to have benefit. But, if they do, they will need to be delivered strategically, in programs that provide clear, integrated messages about the risks and benefits of ARVs for prevention in HIV-negative people. Results from CAPRISA 004, the first ARV-based microbicide effectiveness trial, will be delivered next week at AIDS 2010 and results from initial PrEP effectiveness trials are expected in the next 12 months. The field needs to be prepared to address the many questions that will emerge from these results and develop rational plans for ensuring the best use of the potential new options.

“We must also be ready to be surprised. The greatest advances in the fight against AIDS have come about because people and institutions refused to accept conventional wisdom about what was possible,” Warren said. “In 15 years of advocating for AIDS vaccines, we at AVAC have witnessed many moments when an AIDS vaccine was deemed a scientific impossibility. Yet, a trial that had been all but discounted by many provided evidence that a preventive AIDS vaccine is possible. And AIDS treatment programs and their clients have flourished in every possible context around the globe in the face of those who said it was impossible.”

“Now is the best time to invest in an expanded response to the AIDS epidemic. AVAC stands with the global community of advocates for HIV prevention, treatment, research and implementation to expect and demand an extraordinary response to this unprecedented epidemic—our only hope of closing the book on AIDS,” Warren added.

Turning the Page and other AVAC publications, including an upcoming report on anticipating the results of ARV-based prevention trials are available online at www.avac.org.

Contacts: Mitchell Warren, +1 (914) 661-1536, mitchell@avac.org / Kay Marshall, +1-347-249-6375, kay@avac.org

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Press Release

AVAC Says MDP 301 Microbicide Trial Results Disappointing, But Researchers and 9,400 Trial Volunteers Deserve Praise for Successful Trial

Funding and Support for HIV Prevention Research Must Continue

Press Release

AVAC Praises Thai AIDS Vaccine Trial Collaborators and Volunteers for Historic Study

New York, NY, September 24, 2009 , “Today marks an historic milestone in the search for an AIDS vaccine; we now have evidence that it is possible to reduce the risk HIV infection with a vaccine,” said AVAC executive director Mitchell Warren, reacting to the results of the first AIDS vaccine trial to ever show efficacy at preventing HIV. “It will take time and resources to fully analyze, understand and validate the data, but there is little doubt that this finding will energize and redirect the AIDS vaccine field as all of us begin the hard work to translate this landmark result into true public health benefit.”

“We congratulate the trial sponsors, scientific collaborators and partners who conducted this trial, and especially want to thank the more than 16,400 Thai men and women whose altruism and commitment as trial volunteers made this effort possible. These volunteers and their communities have made an inestimable contribution to HIV prevention research. We all owe them a debt of gratitude,” Warren said. “As we move forward in our search for vaccines and other new HIV prevention interventions, researchers will need the collaboration of tens of thousands more volunteers around the world in additional trials. We are confident that many more communities and individuals will follow in their footsteps.”

As the trial team reported in Bangkok today, the Thai prime-boost trial found that rates of HIV infection were roughly 30 percent lower among volunteers who received the vaccine versus those who received the placebo. This is the first evidence of an AIDS vaccine providing any level of protection against HIV infection. Statistical analyses presented as part of this initial announcement support the validity of the finding. It is important to remember that the trial was a “test of concept” study designed to identify initial signs of promise in a product. The trial sponsors and implementers, led by the US Military HIV Research Program and funded by the National Institutes of Allergy and Infectious Diseases (NIAID), have been clear that additional studies would be needed to further understand any positive result. There is now an imperative on the trial team and the field as a whole to determine what those steps will be and to implement them with all due haste. Additional analysis of the trial data are expected to be presented at the annual AIDS vaccine meeting that will take place in October.

The trial looked at vaccine impact on risk of infection and on viral load among vaccine and placebo recipients who received the vaccine and went on to acquire HIV. The vaccines themselves are not capable of causing infection. There was no evidence of an impact on viral load, a goal that has been embraced by many vaccine stakeholders as more realistic and attainable than an impact on risk of infection.

“These results move us one step further along in the marathon journey of AIDS vaccine research that continues. They also demonstrate that the scientific process is remarkable and unpredictable, and underscores the need for testing strategies in human efficacy trials. We look forward to more data from the trial in the coming weeks that will help guide the decisions about the design of additional trials of this strategy, and the impact of this finding on broader AIDS vaccine research,” Warren said.

“AVAC calls on the trial sponsors, vaccine manufacturers, researchers, funders and others in the field to work quickly, cooperatively and boldly to translate these results into development of a scientific action plan, a plan for community engagement in Thailand and around the world, and a broader communication effort to convey both the promise and limitations of this result. Above all, we must ensure that all stakeholders, including private industry, which played a critical role in this trial, reaffirm their commitments to work that will lead to eventual access to an effective vaccine for people around the world, ” Warren said.

The trial team and Thai collaborators held extensive consultations to determine next steps in various scenarios and determined that a vaccine effect of 50% or higher would trigger a licensure application in Thailand. This finding does not reach this threshold. The same consultations determined that a modest effect, such as was reported today, would trigger additional discussions about the way forward. These new consultations are an essential next step and should include a range of stakeholders including members of communities that might use such a vaccine.

Stakeholders within Thailand and around the world must recognize and rise to the challenge of explaining the promise of this proof of concept as well as the rationale for proceeding with a thorough consultative process and data analysis before making any decisions about future access.

It is important to note that the two vaccines tested in the Thai trial contain synthetic fragments of subtype E, one of the most common HIV strains circulating in Thailand and Southeast Asia. The regimen also contains subtype B, which is most common in North America and Europe. Therefore this result estimates the level of protection conferred by a vaccine that includes genetic fragments matched to the common circulating subtype. Scientists do not know whether a vaccine that is effective against the strains that are found in a given geographical area will also be effective in other areas and against other strains of HIV. The trial collaborators and other experts are already planning follow-up studies to confirm and elaborate on this and other findings from this trial.

“This is an astonishing scientific achievement, well beyond the expectations of many scientists. It starts a new chapter in the search for an HIV vaccine: to make highly protective vaccines that can be made available to all who need them. There is a great deal of work to be done on many fronts at once, and AVAC is fully committed to hastening that day. We need to enlist a larger number of new vaccine advocates to keep the process moving productively as quickly as feasible,” said Bill Snow, an AIDS vaccine activist since 1991, and a co-founder of AVAC in 1995.

There are also still other HIV vaccine strategies in laboratory and human testing. Furthermore, other HIV prevention options, particularly microbicides and pre-exposure prophylaxis, or PrEP, are being tested in efficacy trials which will yield results in the next few years. In the last few years, clinical trials have also shown that medical male circumcision can be effective at reducing the risk of HIV infection in heterosexual men.

“This step adds immensely to the drive for comprehensive HIV prevention,” Warren added. “That means perfecting methods and ensuring access for all who need it to existing HIV prevention and treatment options, including male and female condoms, behavior change counseling, male circumcision, clean needles, harm reduction and antiretroviral drugs; ensuring continued research to find effective new options, including vaccines, microbicides, and PrEP; and planning for integrating these new interventions into combination programs.”

More information about the Thai trial results is available on the AVAC website at http://www.avac.org/thaitrial.htm. Additional information will be added as it becomes available.

Contact: Mitchell Warren, +1 (914) 661-1536, mitchell@avac.org; Kay Marshall, +1 (347) 249-6375

Press Release

Shifting Scientific, Health Priorities and Global Economic Downturn Impact Investment in HIV Prevention R&D

Cape Town — A new report on investment in HIV prevention research in 2008 finds that HIV vaccine research funding levels decreased for the first time since investment trends have been tracked. This may have been influenced by shifts in scientific priorities, the declining economy and competing priorities in the larger global health agenda. Despite this decrease, the overall trend since 2000 has been of increasing investment for experimental biomedical prevention strategies.

The report, Adapting to Realities: Trends in HIV Prevention Research Funding 2000 to 2008, was released at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Cape Town South Africa by the HIV Vaccine and Microbicide Resource Tracking Working Group. It is available online at http://hivresourcetracking.org/.

The report identified investments of almost $1.2 billion in HIV prevention research in 2008, of which $868 million supported vaccine R&D, and $244 million supported microbicide R&D, while other HIV prevention R&D received much lower levels of funding. AIDS vaccine research declined for the first time since 2000, falling by ten percent from 2007 levels. At the same time, funding for both microbicides and preexposure prophylaxis (PrEP) increased by eight and 13 percent, respectively.

Funding for HIV prevention research remains a relatively small percentage of the overall response to HIV/AIDS. A recent report released by the Kaiser Family Foundation and UNAIDS documented commitments from the developed world for HIV/AIDS treatment and prevention programs in developing countries of $8.7 billion in 2008, up from $6.6 billion the previous year.

“Research to develop new HIV prevention tools and strategies is essential to prevent new infections, and an HIV vaccine still holds the greatest hope to ending the epidemic,” said Michel Sidib�, Executive Director of UNAIDS “It is vitally important that investments into research for HIV prevention be sustained and increased for as long as it takes to reach those goals.”

The Resource Tracking Working Group identified a critical need in this time of shifting budget priorities and economic uncertainty for the HIV prevention research field to identify funding needs and put in place scientific plans to help guide research decisions. These steps will ensure that there is no duplication of efforts and that funding can be linked efficiently to scientific priorities.

“Support and interest in HIV prevention research from public, private and philanthropic funders over the last decade has supported key R&D priorities, moved the field forward and brought us closer to new HIV prevention options,” said Mitchell Warren, executive director of AVAC. “We face tremendous challenges — both scientific and economic — over the coming years, but we must not lose the momentum we have gained. The field needs sustained support from a range of funders. The AIDS epidemic shows no signs of slowing, and the desperate need for new HIV prevention options will not change.”

Levels of funding in 2008 reflected key shifts in the HIV prevention research field. The halting in late 2007 of the Step and Phambili vaccine trials, which were testing a candidate vaccine developed by Merck, ended one of the only pharmaceutical company partnerships for HIV vaccine R&D. This slowing in industry involvement is reflected by a decline in industry funding levels in 2008. Pharmaceuticals and biotech companies in 2008 accounted for only four percent of HIV vaccine research funding. Levels were even lower across other HIV prevention research priorities. Nevertheless, the commercial sector contributes to the development of HIV prevention research in a number of ways through pharmaceutical company support. A number of companies have provided ARV compounds for development as potential microbicides, and as oral PrEP, along with technical support to microbicide product developers.

“The worldwide economic crisis has fueled debate about the best way to invest in global health, with some arguing that AIDS takes up resources at the expense of efforts to deal with other diseases and to improve health systems in the developing world. But given that AIDS is the number one killer in sub-Saharan Africa, and number four in the world, it is imperative that we reverse this pandemic, and that can only be done through improved methods of prevention, including a vaccine. If we can conquer AIDS, we will be able to invest resources in other pressing priorities,” said Seth Berkley, President and CEO of the International AIDS Vaccine Initiative.

It is important to note that HIV vaccine research and development is continuing to move forward. Just today, the South African AIDS Vaccine Initiative announced the start of a trial to study a vaccine candidate developed by local South African scientists. Results are also expected later this year from the largest vaccine trial ever, which successfully enrolled more than 16,000 participants. In addition, researchers around the world are developing new vaccine approaches and conducting basic research to inform vaccine development.

The report notes that increased investment in microbicide R&D may reflect increased interest in research on antiretroviral (ARV)-based candidates. Investment increased in microbicides overall at the same time that the field intensified its focus on ARV-based approaches to microbicide development.

“Increased funding for microbicide R&D over the past decade has fostered a major expansion for the field; clinical trials of microbicide candidates have been conducted in 27 countries around the world; and pre-clinical research has yielded important scientific information. Support from public, private and philanthropic funders is essential to increase R&D for new microbicide candidates,” said Polly Harrison, Director of the Alliance for Microbicide Development.

The U.S. government was once again the primary funder for HIV prevention research, supporting 71 percent of HIV vaccine R&D, 63 percent of microbicide R&D, and providing 46 percent of funding for PrEP prevention research in 2008. A decrease in investment from the U.S. National Institutes of Health contributed to the overall decline of funding for HIV vaccine R&D. The U.S. government investment fell by $39 million, a six percent decrease. Other governments also decreased funding for HIV vaccine research in 2008: European government funding fell by 13 percent and total funding from other countries (including Brazil, Canada, India, South Africa, and Thailand) fell by 16 percent.

The report authors caution that while it is too early to attribute all of the funding decreases to the financial crisis, there is concern that a prolonged global recession could have a major impact on public investment in all HIV/AIDS programs. A recent report from UNAIDS and the World Bank found that the economic crisis has already affected levels of funding for treatment and prevention programs in some developing countries.

The Working Group also reported on investment in operational research related to proven biomedical HIV prevention research interventions — medical male circumcision and ARVs for prevention of vertical transmission of HIV from mother to child. These efforts are being funded at much lower levels that other HIV prevention research, with $11 million supporting research related to rollout of male circumcision and $21 million supporting operations research for prevention of vertical transmission.

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Press Release

Piecing Together the HIV Prevention Puzzle: AVAC Report Assesses Progress in AIDS Vaccine, Microbicide and PrEP Research and Calls for Urgent Coordination and Leadership in Advance of Upcoming Results

New York, NY — “It’s an exciting time in HIV prevention research. We will see results from a number of critically important HIV prevention research trials this year, as well as see the start of new trials around the world that will yield important answers in the years to come,” said Mitchell Warren, AVAC executive director, at the release of AVAC’s 13th annual report of the field.

“But scientific, community and political leaders must act now to plan for continued research and implementation of effective strategies, or this excitement will be wasted.”

The report — Piecing Together the HIV Prevention Puzzle — looks at AIDS vaccine research, where there is an energized focus on discovery, innovation and basic science and looks at the broader HIV prevention field, particularly the implications of pre-exposure prophylaxis (PrEP) and other strategies in efficacy trials today.

This analysis of the HIV prevention field comes in a year that has already brought disappointment as well as intriguing results from various prevention studies. At the same time, even trials that failed to show overall benefit, such as the Step Study of the Merck HIV vaccine candidate, have continued to generate new, valuable information and questions that would not otherwise exist.

These trials have succeeded as a result of increasingly robust partnerships between researchers and communities grappling with HIV, including gay men around the world and heterosexual women in Africa. These partnerships, along with the persistently high rates of new infections, are a continual reminder of the global commitment to and need for continuing the search for new prevention for as long as it takes.

“We hope to have new prevention intervention pieces to add to the puzzle in the next few years,” said Warren. “But as the slow implementation of male circumcision to reduce heterosexual men’s risk of HIV infection reminds us, we need extensive planning and guidance to ensure research results are translated into real impact against the epidemic. We can’t afford to wait for efficacy results before we begin to plan. We must anticipate and tackle the major hurdles for implementation now.”

The Report identifies major issues for implementation of new prevention options, including:
–   Ongoing global failures to scale up access to HIV testing and counseling services.
–   Persistent inattention to the needs of gay men and other men who have sex with men around the world.
–   Gaps in health care infrastructure that will complicate introduction of any new strategy.

In the Report, AVAC also underscores the importance of WHO and UNAIDS getting involved in planning for the results from PrEP trials before data are available.
“WHO and UNAIDS, along with other stakeholders, need to combine their strengths now to provide leadership and coordination so that the world is ready to work with results from the many ongoing PrEP trials,” said Warren.

Positive results from current vaccine, PrEP and microbicide trials will also present challenges and opportunities for other ongoing and planned HIV prevention trials.

“There has been concern that positive results from PrEP trials would require vaccine or microbicide trials to become larger, longer and more expensive, as PrEP could become a standard of prevention in these trials,” said Warren. “But we believe that success in one trial will open up possibilities and options for research that could combine AIDS vaccines and other interventions as they emerge.”

To help guide efforts in new areas of research and sustain ongoing research, AVAC calls for researchers and trial sponsors to begin planning on how combination strategies can be evaluated.

As the field looks to fit the puzzle pieces together, the AVAC Report also identifies a number of big questions in AIDS vaccine research for 2009 and beyond, focusing on issues such as cell-mediated viral control, HIV genetic diversity, the role of animal models, immune activation, antibodies and adjuvants.

In its analysis of the vaccine field, AVAC also assesses the progress and future potential of the Global HIV Vaccine Enterprise and considers the impact of results from the Thai prime-boost vaccine trial that are expected in September. With over 16,400 participants, this is the largest AIDS vaccine trial ever undertaken.

“In AIDS vaccine and HIV prevention research today, we see a fertile mix of big science and individual efforts, of product-oriented work and of slow and steady basic science,” Warren added.

“What we need now is a quick, strategic, scientific analysis of all the efforts underway, with a goal of identifying gaps and opportunities for synergy both within the AIDS vaccine field and across the vaccine, PrEP, and microbicide fields. AVAC is excited to help move the HIV prevention field toward a collaborative agenda and to prepare now for implementing potential new prevention options.”

Piecing Together the HIV Prevention Puzzle is available at http://www.avac.org/reports.htm.

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Press Release

Clearinghouse on Male Circumcision for HIV Prevention Web Site Launched

The Clearinghouse on Male Circumcision for HIV Prevention – http://malecircumcision.org/ was launched today. The Web site is designed to generate and share authoritative information about the role of male circumcision in HIV prevention.

The Clearinghouse was initiated by the World Health Organization (WHO), the Joint United Nations Programme on HIV/AIDS (UNAIDS), the AIDS Vaccine Advocacy Coalition (AVAC), and Family Health International (FHI).

“The Clearinghouse will serve as a virtual resource that provides a ‘one-stop-shop’ for the most recent news, research, and resources on the use of male circumcision to prevent HIV,” says Dr. Kim Eva Dickson, Medical Officer, HIV Prevention in the Health Sector at WHO in Geneva. “This site will fulfill the needs of the international public health community involved in male circumcision for HIV prevention , including scientists, civil society groups, policy-makers, health providers, and program managers.”

The Clearinghouse will provide evidence-based guidance to support the delivery of safe male circumcision services as one component in a comprehensive approach to HIV-prevention services. “It will be continually updated with emerging information on country progress in expanding access to safe male circumcision services, including lessons learned in implementation,” says Dr. Catherine Hankins, Chief Scientific Adviser to UNAIDS. “Providing access to tools and guidance, the Clearinghouse is an essential Web site aid for all those working on male circumcision for HIV prevention.”

Visitors to the Clearinghouse will find:

A browsable database of hundreds of scientific abstracts and full-text articles
An inventory of research activities on male circumcision
Tools and guidelines for provider training and program scale-up
Evidence-based protocols and guidelines
A compendium of better and best practices
User-friendly summaries of advocacy issues and civil society engagement
An opportunity to sign up for an RSS feed on news related to male circumcision
A global mechanism for exchanging and integrating information on male circumcision programs and associated services

Experts from leading institutions around the world have reviewed information on the Clearinghouse including:
AIDS Vaccine Advocacy Coalition
Family Health International
Harvard University School of Public Health
JHPIEGO (Johns Hopkins Program for International Education in Gynecology and Obstetrics)
London School of Hygiene and Tropical Medicine
UNAIDS
University of Illinois at Chicago School of Public Health
World Health Organization

“Circumcising men is among the most promising public health tools to reduce new HIV infections in areas most affected by the epidemic,” says Al Siemens, PhD, CEO of FHI. “We are proud to have helped produce such a practical and evidence-based resource for health professionals interested in improving men’s access to high-quality male circumcision services as a component of comprehensive HIV-prevention efforts.”

The Clearinghouse also features user-friendly, regularly updated pages on advocacy issues that are tools for community stakeholders. “To optimize the benefits of male circumcision for HIV prevention, advocates, activists, community, and grassroots organizations need to be involved every step of the way,” says Mitchell Warren, Executive Director of AVAC. “This is an exciting and much-needed resource for sharing information, ideas and approaches to an emerging strategy.”

For more information
News media with questions are welcome to contact the Clearinghouse or call Beth Robinson, Deputy Director for Research Dissemination, Family Health International at +1 (919) 405-1461, or Emily Bass, Program Director, AIDS Vaccine Advocacy Coalition, at +1 (212) 367-1279.

World Health Organization (WHO)
WHO is the coordinating authority for health within the United Nations (UN) system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. WHO is the lead organization within the UN system for supporting the scaling up of male circumcision service provision. WHO is working with UNAIDS, UNFPA and UNICEF to assist countries to make evidence-based policy and program decisions to improve the availability, accessibility and safety of male circumcision and reproductive health services as an integral component of comprehensive HIV prevention strategies. WHO and UN partners use their globally accepted, complementary, normative and convening roles to lead policy setting, develop program guidance and coordinate research to guide countries in making decisions on implementing and scaling up safe male circumcision services for HIV prevention based on available and emerging evidence. Key WHO materials on male circumcision are available on the Clearinghouse on Male Circumcision for HIV Prevention site.

Joint United Nations Programme on HIV/AIDS (UNAIDS)
UNAIDS is an innovative joint venture of the United Nations, bringing together the efforts and resources of the UNAIDS Secretariat and ten UN system organizations in the AIDS response. The Secretariat headquarters is in Geneva, Switzerland , with staff on the ground in more than 80 countries. Coherent action on AIDS by the UN system is coordinated in countries through UN theme groups, and joint programmes on AIDS. UNAIDS’ co-sponsors include UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, ILO, UNESCO, WHO and the World Bank. UNAIDS led the preparatory UN work plan on male circumcision and supports WHO as the lead for UN implementation support for the introduction or expansion of safe, voluntary male circumcision services. UNAIDS recommends that male circumcision always be considered as part of a comprehensive HIV prevention package. Key UNAIDS materials on male circumcision are available on the Clearinghouse on Male Circumcision for HIV Prevention site.

AIDS Vaccine Advocacy Coalition (AVAC)
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 HIV prevention options. AVAC’s participation in the Clearinghouse on Male Circumcision for HIV Prevention is one component of its ongoing work on increasing informed civil society input on male circumcision for HIV prevention. AVAC has developed a range of tools for advocates in developing and developed countries and continues to convene civil society conference calls, issue-focused meetings, and electronic dialogues as forums for input on this and other issues in HIV prevention.

Family Health International (FHI)
FHI works to address key public health and development needs in developing countries, including family planning, child and maternal health, infectious diseases such as HIV/AIDS, malaria and tuberculosis, and chronic conditions such as cardiovascular disease. FHI also works to strengthen broader health systems. Through a grant from the Bill & Melinda Gates Foundation, FHI and its international partners , the University of Illinois at Chicago and EngenderHealth , are establishing a Male Circumcision Consortium to improve and expand voluntary male circumcision services in Kenya. FHI serves as the webmaster for the Clearinghouse on Male Circumcision for HIV Prevention, and in partnership with WHO, UNAIDS and AVAC, develops and selects content for the site.

Press Release

New AVAC Report on Pre-Exposure Prophylaxis Calls for Immediate Planning to Anticipate Study Results of Potential New HIV Prevention Option:

Mexico City, Mexico, August 3, 2008 — The AIDS Vaccine Advocacy Coalition (AVAC) today released a new report, Anticipating the Results of PrEP Trials, calling for increased action from governments, global health institutions, donors, researchers, and advocates to prepare for initial results — expected as early as 2009 — from the first trials of antiretroviral drugs being tested for HIV prevention, known as PrEP or pre-exposure prophylaxis. The report also provides the most up-to-date information about ongoing and planned PrEP research, and lays out an agenda for action on key issues that must be addressed as research on this promising HIV prevention intervention moves forward.

The new report is available online at http://www.avac.org/prep08.pdf.

PrEP clinical trials are currently planned or underway in countries in Africa, Asia, Latin America and North America. These studies are looking at the safety and efficacy of PrEP, an unproven strategy in which HIV negative people could take an antiretroviral drug (ARV), or combination of ARVs, on a regular basis in the hopes of reducing their risk of acquiring HIV.

The AVAC report was released today at a special session of researchers, advocates and other stakeholders, held at the XVII International Conference on AIDS in Mexico City to discuss the challenges of translating PrEP and other HIV prevention research into effective policy and practice.

“PrEP trials are taking place within a changing landscape of HIV prevention research,” said AVAC Executive Director Mitchell Warren. “Disappointing results have emerged from recent studies of vaccine and microbicide candidates, while male circumcision was found to be partially effective at preventing HIV transmission in some populations and is being rolled out in some African countries.

“Although still unproven human clinical research, PrEP is considered one of the promising clinical interventions against HIV currently in development,” Warren continued. “By mid-2009, more people will be enrolling in PrEP studies than in both HIV vaccine and microbicide efficacy trials combined. Advocates and communities affected by HIV need to understand PrEP and its implications for the AIDS advocacy and global health agendas, and government and private funders committed to global health must step forward now to ensure that PrEP research is fully funded.”

“We cannot wait for the study results to begin to prepare for the optimal use and delivery of PrEP,” said Pedro Goicochea, an investigator of the iPrEx PrEP study currently underway in Peru and Ecuador “Instead, we should look ahead to consider all of the possible outcomes of these trials and make real plans for making PrEP available to those who can benefit from it, as quickly and safely as possible if it is proven effective.”
Anticipating the Results of PrEP Trials provides an up-to-date status report on current PrEP research; addresses concerns about PrEP, including the possibilities of drug resistance, partial efficacy, and the potential for increased risk behavior and social stigma; looks at the potential impact of PrEP on future HIV prevention research; and considers what questions should we be preparing to ask now based on possible different research outcomes as PrEP studies begin reporting data in the next few years.

“This report provides an important overview of PrEP research and lays out the many difficult issues that are critical for advocates, communities and public health experts to understand as trials continue and report results,” said Warren. “We cannot shy away from discussing issues such as potential drug resistance, the difficulty of adhering to a once-a-day pill regimen for people who are not sick, or the cost of providing PrEP. This report and today’s meeting lay the groundwork for these important discussions.”

AVAC’s report identifies five priority issues that need attention now, including:
1. Ensure that current clinical trials have the best chance of providing results: Clinical trials now underway in Thailand, Africa, Latin American and the U.S. could establish the safety and effectiveness of PrEP, but only if these trials produce clear answers. Trial sponsors, regulatory agencies and the global health community must work together to ensure that these studies are supported to produce the data needed to determine next steps on the possible use of PrEP.

2. Identify and invest in additional research: A plan for launching additional studies — including studies on the safety and efficacy on intermittent PrEP dosing, bridging studies in additional populations, and safety and efficacy of other candidates — is needed now and will require additional funding.

3. Plan now for optimal use of PrEP: A plan of action for using PrEP to maximum public health impact should be developed now. This plan should address the issues set out in a Lancet paper of July 2007, which called for assessing appropriate settings and populations for PrEP use, determining what level of efficacy would warrant widespread delivery and determining where targeted vs. more generalized delivery would be more appropriate.

4. Prepare for global procurement and delivery of PrEP: Plans for PrEP delivery must include a well-planned and resourced campaign to deliver PrEP, an understanding of which global funders will pay for PrEP, plans for rollout, and guidance and support similar to that implemented for male circumcision.

5. Provide adequate financing: Underinvestment in PrEP is hampering progress and must be corrected. Government and private funders committed to global health must step forward now to ensure that PrEP research is fully funded.

AVAC’s Anticipating and Understanding Results series provides timely analysis of trials of new HIV prevention options. For other publications in the series, visit http://www.avac.org/.

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About AVAC: Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is an international nonprofit, 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 HIV
prevention options. For more information, visit http://www.avac.org/.

Press Release

Immunizing Against Misinformation and Shortsightedness: AVAC Report Injects a Dose of Reality into the Debate on the State of AIDS Vaccine Research

New York, NY , The AIDS Vaccine Advocacy Coalition (AVAC) today released a new report that provides a comprehensive review of recent developments in AIDS vaccine research. AVAC Report 2008: The Search Must Continue explores the issues that have been raised in the wake of the failure of Merck’s vaccine candidate and provides context for the events and major changes of the last year in HIV prevention research.

In the Report’s opening letter, AVAC Executive Director Mitchell Warren says “Enough is enough,” with regard to the misinformation that has crept into some of the public conversations about AIDS vaccine research. In the report, AVAC argues that continuing to move forward with AIDS vaccine research and testing is imperative and lays out recommendations for the AIDS vaccine and HIV prevention field.

AVAC’s 11th annual Report on AIDS vaccines also looks at the comparative advantages of major players, including the U.S. National Institutes of Health and the International AIDS Vaccine Initiative, and analyzes the current environment for decision-making about future clinical trials. The report is available online at www.avac.org/reports.htm.

The AVAC Report comes at a critical time for HIV prevention research. Over the past 12 months, several trials, including vaccine, microbicide, cervical barrier method and herpes-treatment trials, have yielded disappointing results of no efficacy. Recently, a slew of editorials and media coverage have spotlighted AIDS vaccine research and, in some instances, included calls to end public funding or to reapportion funding away from AIDS vaccine research toward existing HIV treatment or prevention interventions. At the same time, there are ongoing discussions at the NIH about whether to launch another vaccine efficacy trial using a strategy developed by the NIH’s Vaccine Research Center.

“With recent pessimistic headlines and the creation of na�ve and false dichotomies between research and clinical trials or between treatment and prevention or existing interventions and new research, we at AVAC say enough is enough,” said Mitchell Warren, executive director of AVAC. “An AIDS vaccine is possible, and it is essential.”

“It’s been a challenging year for the AIDS vaccine field and for HIV prevention research generally, but the recent spate of statements that seem to revise the history of the past few years of AIDS vaccine research are deeply troubling,” said Warren. “Now more than ever, we must maintain momentum in AIDS vaccine and other HIV prevention research while simultaneously continuing to ramp up provision of existing treatment and prevention options for all those who need them.”

“We were all disappointed with the results from the trials of Merck’s vaccine candidate last year,” said Pontiano Kaleebu, Assistant Director of the Uganda Virus Research Institute, Chairperson of the African AIDS Vaccine Programme, and an AVAC board member. “But we must now reclaim the narrative of what happened with trials of that vaccine and of what they mean for the future of AIDS vaccines and HIV prevention. Here in Uganda and throughout Africa and the world, we still desperately need an AIDS vaccine and we are committed to continuing the search.”

“There have been major changes in the AIDS vaccine field and in biomedical HIV prevention research in the last year. The AVAC Report provides a comprehensive and sensible guide to where the vaccine field stands now and where it needs to go,” said Alan Bernstein, executive director of the Global HIV Vaccine Enterprise.

In The Search Must Continue, AVAC makes several key recommendations for moving the AIDS vaccine and HIV prevention research fields forward, based on a comprehensive review of recent events in the field and future plans of the major players in AIDS vaccine and HIV prevention research as well as conversations with researchers, funders, policy makers and community representatives. These recommendations include:
Ensure that the scientific data from the STEP trial are fully assessed and used to inform the design of improved immunization strategies.
Articulate the human discovery trials agenda and balance vaccine discovery and development.
Structure the vaccine field so that there are career paths for young investigators.
Prepare for results of the Thai prime-boost vaccine efficacy trial.
Systematically improve community engagement strategies, especially as decisions are made around the design of the PAVE 100 vaccine trial.
Clearly communicate and manage expectations of prevention research trials and results.
Increase support for pre-exposure prophylaxis (PrEP) research as well as community stewardship of this promising area of research.
Engage in meaningful dialogue around the scaling-up of male circumcision programs that adequately address HIV testing and gender-specific issues in program rollout.
Expand community engagement with and critique of the microbicides science agenda.
Reconsider how clinical trials infrastructure is sustained and clinical research agendas are developed, in discussion led by developing country voices.

The Report is being released ahead of HIV Vaccine Awareness Day, May 18th, which commemorates U.S. President Bill Clinton’s call for a concerted effort to develop an AIDS vaccine within a decade. Today, it is a global observance to recognize and thank the thousands of volunteers, community members, health professionals, researchers and scientists who are working together to find a safe and effective AIDS vaccine.

“Yes, we have all been surprised and disappointed in the results of the Merck vaccine candidate,” Warren said. “But that is the nature of the scientific process. To acknowledge failure of a candidate vaccine is in no way to concede overall defeat. We all now have a tremendous opportunity to learn from these setbacks and to be better for them, better, even, than we might have been without them. This year, as we commemorate HIV Vaccine Awareness Day, AVAC remains committed and cautiously optimistic.”

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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 HIV prevention options. For more information, visit http://www.avac.org/.

Press Release

Safety of Trial Volunteers Must Remain Paramount Concern

WedSeattle, Washington, November 7, 2007, The AIDS Vaccine Advocacy Coalition (AVAC) released the following statement today from Executive Director Mitchell Warren in response to the release of new data from the STEP AIDS vaccine study by Merck & Co., the US National Institute for Allergy and Infectious Diseases (NIAID) and the HIV Vaccine Trials Network (HVTN) at a public forum at the HVTN meeting today.

The data from the STEP study released today confirm that the vaccine was not effective at either preventing infection in male volunteers or at reducing viral loads in male vaccine recipients who became infected with HIV during the trial. In addition, the data suggest that the vaccine may have made some volunteers more susceptible to acquiring HIV infection. The vaccine itself does not cause HIV. This trend was specifically observed among male volunteers who had high titers of antibody to adenovirus, the cold virus that was used, in a disabled form, in the MRK-Ad5 vaccine candidate.

“These data are deeply disappointing and troubling, and raise more questions than answers for the field of AIDS vaccine. Today’s discussion of the data underscores the leadership and transparency that Merck, NIAID, and HVTN continue to show in this complex and challenging time. What is clear is that the field must continue to work on this challenge and on the larger goal of finding a safe and effective AIDS vaccine.

“As much as we would like to see a clear answer in these results to whether or not the vaccine made some volunteers more susceptible to HIV infection, the reality is that there is still significant confusion about the underlying explanation for the observed effect.

“As we move forward, the work of analyzing and interpreting the data from the STEP study, and from the companion Phambili study in South Africa, will become even more difficult and even more important.

“In the weeks and months to come, we look to the AIDS vaccine field as a whole to maintain a collaborative spirit and to commit all necessary resources to the critical work of understanding the potential explanations and implications for the trends observed in the STEP study.

“We commend the trial sponsors for their consistent commitment to the safety of the volunteers, which must be the top priority in this and every other HIV prevention trial. At every stage of this difficult process, trial sponsors and site-level staff must continue to clearly communicate key information about the data and the participants’ potential risk to volunteers at every site.

“AVAC recognizes that these data leave the AIDS vaccine field with a range of difficult decisions. Going forward, we believe that the wisest course of action is also the most cautious. To safeguard future trials and volunteers, the trial sponsors and the field as a whole should take as long as is needed to analyze the data and attempt to come to more definitive conclusions about what these new data mean, before beginning efficacy trials of other vaccine candidates.

“In addition, if there is the possibility that unblinding the STEP study and informing every participant about whether he or she received the placebo or the vaccine will provide an additional safeguard for participants, then this is the course of action that should be taken. AVAC believes that ultimately the decision about unblinding the trial should be guided by the participants’ own concerns and priorities.

“Above all, we must continue to see this for what it is: a major setback for the AIDS vaccine field, but one that can and must be overcome through rigorous scientific investigation, open communication with communities, and a firm commitment to the shared goal of reversing the course of the AIDS epidemic in our lifetimes.”

AVAC will continue to provide updates, analysis and resource materials at http://avac.org/pr_step_study.htm as the decision about unbinding the trial is made and as more analyses and data are released.

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