Press Release

AIDS Vaccine Advocacy Coalition Receives $14 Million Grant from Gates Foundation to Develop International HIV Prevention Research Advocacy Network

New AVAC Report on the State of the AIDS Vaccine Field Calls for Accelerated Action in AIDS Vaccine and HIV Prevention Research

Seattle — The AIDS Vaccine Advocacy Coalition (AVAC) announced today at the AIDS Vaccine 2007 Conference that it has received a five-year, $14 million grant from the Bill & Melinda Gates Foundation to create a new international HIV Prevention Research Advocacy Network.  The Advocacy Network will work with civil society, policymakers, and research partners around the world to advance ethical research and development of new HIV prevention interventions, ensure that communities are informed about and involved in prevention research, and ensure that the benefits of research are shared globally.

The new grant broadens AVAC’s advocacy focus beyond AIDS vaccines, to include other new HIV prevention interventions such as microbicides and oral prevention drugs.

“We are entering a new era in HIV prevention research, with more products being tested in efficacy trials than ever before,” said Mitchell Warren, Executive Director of AVAC.  “A coordinated global effort is urgently needed to support the wide range of prevention research, to ensure that the voices of civil society and communities are heard, and to prepare for results from these trials.”

“It is essential to build support for and understanding of how new HIV prevention tools will help accelerate efforts to slow this epidemic,” said Joe Cerrell, Director of Global Health Advocacy for the Gates Foundation.  “AVAC has been an important voice in AIDS vaccine advocacy for the last decade, and we are extremely pleased to support this broadening of its work.”

“This generous grant from the Gates Foundation will allow AVAC to expand our advocacy efforts and build a global network of advocates who will work to promote HIV prevention research and help communities prepare for the use of new HIV prevention options,” said Mike Powell, President of the AVAC Board of Directors.

AVAC remains committed to advocacy for effective AIDS vaccines, and will now be able to expand its work.  The new international HIV Prevention Research Advocacy Network will:
� Develop international advocacy partnerships that support both the needs of communities involved in research and a global advocacy movement for HIV prevention research.
� Translate complex scientific ideas to communities AND translate community needs and perceptions to the scientific community.
� Work to hold both research agencies and advocates accountable for accelerating ethical prevention research and development.
� Help ensure that communities, policymakers, and civil society have realistic expectations about HIV prevention research and specific clinical trials.
� Work closely with other groups conducting HIV prevention research advocacy, including microbicide advocacy groups.

“With so many clinical trials of HIV prevention interventions underway or planned in the next few years, there is an urgent need for a global advocacy network that will expand and support partnerships among the different groups working in the field,” said Lori Heise, Director of the Global Campaign for Microbicides.

Developing and maintaining strong support for clinical research of new HIV prevention interventions can be difficult in many communities and countries, but is necessary if ethical research is to take place in these communities.  The Advocacy Network will link advocates, researchers, and policymakers from around the world and will share information and identify and promote “good practices” for advocacy and clinical research.

“This network will provide an important knowledge base for those of us working on and supporting clinical trials in our communities,” said Manju Chatani, coordinator of the African Microbicides Advocacy Group. “We look forward to working with AVAC and other partners to strengthen HIV prevention research advocacy here in Africa and in communities around the world.”
Resetting the Clock — New AVAC Report Examines State of the AIDS Vaccine Field and Calls for New, Ambitious Deadlines for Vaccine Development

AVAC also released its annual report examining the state of the AIDS vaccine field today at the AIDS Vaccine 2007 Conference.  The new report, entitled Resetting the Clock, outlines the specific deadlines and challenges facing the field in the arenas of AIDS vaccine scientific strategy, clinical trials, and the broader prevention field and provides recommendations for action by researchers, policymakers, industry, funders, civil society, and advocates, including AVAC.

The report also discusses progress and challenges of the Global HIV Vaccine Enterprise, an alliance of independent partners committed to accelerating the development of an AIDS vaccine. AVAC is one of the founding stakeholders of the Enterprise.

“We will soon have data from the test-of-concept studies of novel AIDS vaccine candidates,” said Warren.  “It is time to reset the clock to launch a countdown for meeting new, ambitious deadlines for developing new vaccine concepts and candidates that will be needed whether or not there is evidence of benefit from these first test-of-concept trials.”

Key features of Resetting the Clock include:
� New Countdowns looks at progress and barriers in funding and strategy-setting for the vaccine field, addresses key questions about what needs to be done as we wait for the results from current trials, and looks at the responsibilities of key institutions.  It also includes an updated industry survey.
� Racing Against Time examines clinical trials issues and finds that the field is already in danger of slipping behind on several fronts, including clinical trials capacity, consensus on standards of prevention and levels of care, and new funding structures for US prevention research networks.
� Wake Up Call explores the critical lessons to be learned from responses to male circumcision and HPV vaccine introduction.  It also includes a survey of advocates from other areas of the AIDS response about prevention research.
“This report shows that the current state of HIV prevention research is troubling and challenging.  It is time for all AIDS advocates to re-exam�ine their messages, their missions, and their goals for the next five to ten years,” said Warren.  “We at AVAC remain committed to our advocacy for an effective AIDS vaccine and are excited about expanding the scope of our work to include the broader field of HIV prevention research and working with new partners around the globe to ensure that the world finds a way to defeat HIV/AIDS.”

Resetting the Clock is available online at http://www.avac.org/reports.htm.

# #

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

AIDS Vaccine Advocacy Coalition calls for renewed commitment to vaccine research on anniversary of President Clinton’s 10-year challenge

Call for new urgency, targets and leadership to accelerate research on HIV Vaccine Awareness Day

New York, NY — On May 18, 1997, US President Bill Clinton called for a concerted effort to develop an AIDS vaccine within a decade. This year we mark the 10th anniversary of that call for action with a global AIDS epidemic that rages on, and without a preventive HIV vaccine.

“Over the past decade, we have seen great progress in AIDS vaccine development, and we now see signs of great hope for development of a vaccine,” said Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC). “But we have fallen short of the goal set out by President Clinton. Critical elements of the accelerated, comprehensive effort that we need to deliver on the promise of an AIDS vaccine are missing.”

In its special HIV Vaccine Awareness Day report, “The Countdown Continues” (available at http://avac.org/pdf/hvad_the_countdown_continues.pdf), AVAC identifies key issues and obstacles to an accelerated, comprehensive approach to AIDS vaccine development and challenges vaccine researchers, advocates, and funders to:

�    Accelerate and better coordinate research and testing of vaccines and other potential new HIV prevention technologies.
�    Sustain clinical trial capacity internationally, especially in communities where the HIV epidemic is most severe.
�    Develop bold and well-resourced plans for vaccine research and community education in all populations at high risk for HIV infection, not only those who are “easier” to reach.
�    Prepare for results of current AIDS vaccine efficacy trials by examining different efficacy scenarios.
�    Ensure that research results of all current trials are widely shared in order to help develop better next generation AIDS vaccine candidates.
�    Urgently expand access to proven HIV prevention options and treatment for all who need them.
�    Bring new, young investigators into AIDS vaccine research.

Ten years ago, President Clinton said, “[W]ith the strides of recent years, it is no longer a question of whether we can develop an AIDS vaccine, it is simply a question of when.”  While the dream of having that vaccine in the first decade of the 21st century has not come true, the world has, nonetheless, made tremendous advances in the past decade.
Global resources for AIDS vaccine development, while still short of what is needed, have quadrupled; the number of countries with clinical trials capacity has expanded from North and South America and Europe to include Asia and Africa; and more than 25,000 brave men, women, and children have stepped forward to volunteer for AIDS vaccine trials around the world.

On this anniversary, AVAC reaffirms its commitment to advocacy for a new clinical trials paradigm that recognizes the need for partnerships that include those from scientific and non-scientific domains. These partnerships both improve research and ensure that communities can immediately benefit from the conduct of clinical trials whose ultimate goal , an AIDS vaccine , may still be years away.

“If we are to sustain the necessary momentum to develop and distribute an AIDS vaccine, advocates, activists, scientists, trial volunteers and concerned citizens must work together to create a new paradigm for AIDS vaccine research and development. We must get better at answering the �question of when,’ and be able to explain why it is taking so long to develop a vaccine. And we must also take every step necessary to ensure that delays are avoided, whether in product development, regulatory decisions, or manufacturing,” said Warren.
“If one candidate fails, we must ensure that communities everywhere know this is not the end of the road. We must be sure that there is another candidate moving steadily forward into clinical trials,” he added. “We will ultimately measure the search for an AIDS vaccine in decades, but both President Clinton’s sense of urgency and optimism must remain with us as we continue the countdown to a day when the AIDS epidemic is over.”

# # #

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 www.avac.org.

About HIV Vaccine Awareness Day:
Each year on May 18th, people around the world commemorate HIV Vaccine Awareness Day, an 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 HIV vaccine. It is also a day to educate our communities about the importance of HIV vaccine research and development. More information at http://avac.org/hvad.htm.

Press Release

AIDS Vaccine Advocacy Coalition Calls for Strategic Leadership and Urgency in the Implementation of Male Circumcision for HIV Prevention

New York, NY — Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC) today issued the following statement regarding the new recommendations from the World Health Organization (WHO) and UNAIDS on male circumcision as an HIV prevention strategy.  

“AVAC welcomes the new recommendations from WHO and UNAIDS on the range of policy, operational and ethical issues that will help guide countries about where and how male circumcision can be best implemented, promoted, and safely performed. These normative recommendations are essential to ensuring successful rollout of male circumcision to protect against HIV infection.

“Adding the offer of safe, sterile, voluntary male circumcision to existing HIV prevention programs could avert many infections and save many lives. These programs could also provide a new way to reach men and adolescent boys who are frequently under-represented in health clinics and HIV prevention programs.
 
“As important as the new recommendations are, though, they are only a first step in translating research findings into real public health impact. This international guidance document must now be complemented by funding, technical assistance and operational research at the country level to help national governments and health ministries develop and implement policies and programs to ensure that male circumcision is as part of a comprehensive package of prevention interventions.

“If these resources are not immediately forthcoming, there is a real risk that the benefits of male circumcision will be negated by complications relating to unsafe surgeries performed by unskilled practitioners seeking to profit from demand, which is likely to increase as news of these data spread through communities around the world.

“It is also absolutely critical to recognize the unanswered questions about male circumcision, including: whether it is safe for HIV-positive men and their partners; whether it provides any protective benefit to women who are sexual partners of circumcised, HIV-positive men; and whether it has any protective benefit in the context of anal sex.

“But not having all the answers should not stop us from making the first big steps of using the overall finding to help reduce new infections. Making and resourcing clear plans for filling in these gaps must be given equal priority to rollout based on what we know today.

“The benefits of male circumcision can only be realized if male circumcision is offered in programs that contain clear, cultural and context-specific messages and that explain the benefits and limitations of the procedure for men and their sexual partners and the importance of proper wound healing before resuming sexual activity.

“Policymakers will face complex decisions as they seek to implement these recommendations. Decisions about targeting high-risk men should be made with the utmost care, and it is also essential that circumcision not become falsely viewed as an indicator of HIV-negative serostatus. Programs must develop communications strategies and packages of services that counter this impression and meet the needs of HIV-negative men, HIV-positive men, and especially their partners.

“Research and dialogue are also needed now to explore the feasibility of rolling out infant circumcision. This approach will not show immediate benefits in terms of HIV incidence but can minimize risks and could be a highly cost-effective implementation strategy over the long term.”

AVAC’s report on understanding the results of the male circumcision trials as well as a detailed statement on research priorities for male circumcision and advocacy fact sheets for civil society in the US and in sub-Saharan Africa are available at www.aidsvaccineclearinghouse.org/MC.

About AVAC: Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other prevention options.

Press Release

AVAC Applauds Commencement of First HIV Vaccine Efficacy Trial in Africa

New York, New York — The AIDS Vaccine Advocacy Coalition (AVAC) heralds today’s launchof the first African efficacy trial of an experimental HIV vaccine as a critical, strategic and historically-significant step in the search for an AIDS vaccine.

The trial, which is known as Phambili (a Xhosa word meaning “moving forward”) or HVTN 503, was launched today in South Africa by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN) of the US National Institutes of Health.

“South Africa and the partner agencies in this study are demonstrating tremendous leadership. With the stakes as high as they are in the epidemic, accelerating large-scale efficacy trials in the countries and communities that need an HIV vaccine the most is the kind of forward-looking, strategic decision-making that the field needs and should embrace,” said Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC).

The same vaccine candidate, which has been developed by Merck Research Laboratories, is currently being tested in another efficacy trial being conducted in various sites in North and South America, the Caribbean and Australia. The data from this study, known as the Step Study, are not yet known. Phambili has been initiated before the conclusion of the Step Study to help speed the progress of gathering additional important data in sub-Saharan Africa.

“The timing of the Phambili trial launch is a bold decision,” said Warren. “There is an urgent need to identify new AIDS prevention strategies as quickly as possible; this sequence of trials will help move the field forward as quickly as possible. These two trials will combine to shed light on whether this vaccine candidate has the potential to be a truly global vaccine that can eventually be used in both developed and developing countries.”

“As this trial moves forward, AVAC also hopes that this vaccine candidate will also be studied among adolescents. Adolescents are at great risk of HIV infection, and AVAC strongly supports the inclusion of adolescents in future trials so that we can get answers as quickly as possible for this priority population,” Warren said.

“Finding an effective AIDS vaccine will not happen in one isolated sector or country, but from international collaborations between industry, government agencies, academia, and publicprivate partnerships. Phambili is an excellent example of putting public funds to good use to test a promising vaccine candidate,” Warren said.

While there have been a significant number of small and mid-size safety studies conducted in sub-Saharan Africa, Phambili is the first study that is designed to provide information on whether or not a vaccine protects against HIV infection or helps to blunt HIV disease. Neither the Step study nor the Phambili trial has been designed as the final study of this vaccine candidate; if there are indications of efficacy, additional studies will be conducted to confirm this preliminary finding.

About AVAC: Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a 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 prevention options. For more information, visit www.avac.org.

Press Release

Leading advocates express support for microbicide research, despite disappointing clinical trial results

HIV prevention advocates from three major civil society organizations today emphasized the importance of continued research into new HIV prevention options, despite the recent discontinuation of the Phase III effectiveness trials of the microbicide candidate, cellulose sulfate (CS).

CS was one of the four microbicide candidates in Phase III effectiveness trials for prevention of HIV and other sexually transmitted infections. CONRAD, a reproductive health research organization, was conducting Phase III trials to assess its effectiveness in Benin, India, South Africa, and Uganda. Another Phase III trial of CS sponsored by Family Health International was underway in Nigeria. Both sponsors are not-for profit research groups dedicated to advancing health in developing countries.

At the recommendation of their respective Data Safety Monitoring Boards both sponsors chose to discontinue their CS trials after findings from the CONRAD trial suggested that CS might be contributing to an increased risk of HIV infection. Although review of the data from the Nigerian trial found no evidence of increased risk, FHI felt that the only responsible course of action was to halt its study also.

“Of course we wish the results had been different, but learning what doesn’t work can be just as important to progress as learning what does work,” observed Lori Heise, Director of the Global Campaign for Microbicides (GCM). “It’s also reassuring that the independent Data Safety and Monitoring Committees, put in place to identify problems early on in a trial, appear to have worked well. Advocates have been instrumental in pushing for extra mechanisms to help protect participant safety.”

African advocates are following the trials conducted in their countries particularly closely, reported Manju Chatani, Coordinator of the African Microbicide Advocacy Group (AMAG).  “Scientists scrutinized the data available on cellulose sulfate before the Phase III trials started, including safety results from 11 clinical trials done in Africa, India and the US. All the data suggested that the product was safe and should proceed into Phase III trials,” she said.

“This is a setback but it does not detract from the issue that women still don’t have the tools they need to protect themselves from HIV”, Chatani added. “And African women, especially, urgently need more prevention options. So while we need concrete answers to why this happened as soon as possible, we must continue to research new options so women don’t have to ask for permission to protect themselves”

Dr. Kim Dickson, an African physician who serves on the boards of both GCM and AMAG, noted that care and treatment of trial participants are among the top concerns of both groups, along with clinical trial ethics. “At civil society’s insistence, the trial investigators forged written agreements in advance to assure that any women who sero-converted while enrolled in the trial would get ongoing care and treatment, including anti-retroviral drugs as needed”, she said. “Our priority now is to make sure that advocates’ and community questions about this trial and future research are heard and addressed as soon as possible.”

Adding his perspective, Director of the AIDS Vaccine Advocacy Coalition (AVAC) Mitchell Warren observed that “Getting a negative result for one product certainly doesn’t signal failure for the microbicide field or broader biomedical HIV prevention research effort as a whole. The nature of research is that the information gathered is cumulative”, he continued. “Each trial result is a puzzle piece and, together, they make up the complex picture that will show us how to develop successful new HIV prevention tools.”

Heise concluded by noting that “The real heroines and heroes in this are the people who enroll in clinical trials because they know how urgently new prevention tools are needed. In Benin, South Africa, and Uganda, the African countries in which the CS trials were being done, between one third and one half of all women of reproductive age are already HIV positive”, she added. “It is essential to build on what has been learned here and proceed with the research as rapidly as possible. Millions of women’s lives are at stake.”

# # #

The Global Campaign for Microbicides is an international movement of activists, citizens and not for profit organizations dedicated to accelerating access to new HIV prevention tools, especially for women. www.global-campaign.org. Dr. Kim Dickson. +41 (22) 791 4548; cell: + 41 79 368 6259.

The African Microbicides Advocacy Group (AMAG) is a coalition of microbicide advocates from organisations and institutions based and/or working in various African countries. www.globalcampaign.org/amag.htm. Contact: [email protected]; + 233 21 225 180; cell: +233-244-503026

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.
www.avac.org.
Contact: [email protected], +1 212 367 1084.

Contact for Family Health International: Beth Robinson, + 1 919 405 1461, [email protected],
http://www.fhi.org/en/AboutFHI/Media/index.htm

Contact for CONRAD: Annette Larkin, +1 202 429 4929, cell: +1 703 772 6427,
[email protected]

Press Release

HIV Vaccines and Microbicides Resource Tracking Working Group Releases Preliminary Data and Launches New Website

The HIV Vaccines and Microbicides Resource Tracking Working Group was established in 2004 to generate and disseminate high-quality, detailed and comparable data on annual investments in preventive HIV vaccine and microbicide research and development (R&D), and policy and advocacy activities. These data can be used to monitor current levels of effort; identify trends in investment, spending, and research focus; identify areas needing more resources and effort; assess the impact of public policies aimed at increasing investment in new prevention technologies (NPTs); and provide a fact base for policy advocacy on R&D investments and allocations.

The Working Group is comprised of the AIDS Vaccine Advocacy Coalition (AVAC), the Alliance for Microbicide Development (AMD), the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS).

To coincide with the current UNGASS review taking place this month, the Working Group has generated new estimates of public sector investment in HIV vaccine and microbicide research, development, and advocacy in 2005.

According to a preliminary report, the public sector invested an estimated US $654 million in preventive HIV vaccines and about US$ 139 million in microbicides in 2005. A full report on global investment in these technologies – including funding from philanthropic institutions and private industry – will be available in August 2006.

We have launched a new website at http://www.hivresourcetracking.org/ has this latest report as well as the reports published on each technology in 2005 along with PowerPoint slide presentations with the report results.

For more information on HIV vaccines, please contact the AIDS Vaccine Advocacy Coalition ([email protected]) or the International AIDS Vaccine Initiative([email protected]).

For more information on microbicides, please contact the Alliance for Microbicide Development ([email protected]).

For more information on UNAIDS resource tracking activities, please contact the UNAIDS Resource Tracking Unit ([email protected]).

Press Release

Launch of AIDS Vaccine Clearinghouse

The AIDS Vaccine Advocacy Coalition (AVAC) is delighted to announce the launch of its new AIDS Vaccine Clearinghouse, a comprehensive and interactive source of AIDS vaccine information on the Internet. The website, http://www.aidsvaccineclearinghouse.org/, provides a gateway to information and a link to people and organizations interested in AIDS vaccine advocacy, research and global delivery.

The Clearinghouse is divided into separate content sections that each provides an overview, frequently asked questions and “top picks” of other sources to go to for further information on a particular topic. The site covers a wide variety of issues, all of which greatly affect the work of advocates, community members, researchers and policymakers as we work to develop an AIDS vaccine. The Clearinghouse includes both original content and annotated links to other helpful resources. The following sections are included:
� General & Introductory Information
� Vaccine Science, Research & Development
� Clinical Trials Around the World, including a list of clinical trials and trial sites with contact details to get more information
� Communities and Cohorts, with special sections dedicated to issues related to adolescents, women, gay men, sex workers, injecting drug users (IDUs) and African- Americans.
� Participation in a Trial
� Ethics & Human Rights
� Community Involvement
� Vaccine Advocacy
� Policy
� Global Access
� Comprehensive Response to AIDS, which discusses shared issues among AIDS treatment, prevention, and research advocates.
� Global HIV Vaccine Enterprise
� PrEP Watch, which provides comprehensive information on pre-exposure prophylaxis research

In addition, AVAC is simultaneously launching a new Advocates’ Network – an electronic resource for organizations and individuals interested or already involved in advocacy for the development of vaccines for HIV/AIDS. Linked to the Clearinghouse, the Advocates’ Network will provide regular electronic announcements, updates and notices of events or activities related to AIDS vaccine and other prevention research. Advocates can also submit events and activities to be included in the Advocates’ Network Calendar – a calendar of AIDS vaccine related activities around the world. You can join the Network by sending an e-mail to [email protected].

The Clearinghouse and the companion electronic “Advocates’ Network” are being launched in conjunction with the 9th annual HIV Vaccine Awareness Day, a day designed to educate communities about the importance of HIV vaccine research and thank the thousands of volunteers who have participated in clinical trials.

Press Release

AIDS Vaccine Advocacy Coalition Issues Report on Tenofovir Prevention Trials: Calls for coordinated response to ensure trials continue

 NEW YORK – The AIDS Vaccine Advocacy Coalition (AVAC) today released a report on issues surrounding clinical testing of the antiretroviral drug tenofovir as pre-exposure prophylaxis (PREP) – a possible once-a-day pill for prevention of HIV.

Legitimate ethical concerns raised by some advocates have led to cancellations and delays in some of the PREP trials. The AVAC report, “Will a Pill a Day Prevent HIV? Anticipating the Results of the Tenofovir “PREP” Trials,” examines the issues surrounding the tenofovir trials and makes recommendations for ensuring that trials are carried out ethically and that provisions are made for dealing with the results of the trials when they are available. The report also calls for more concerted coordination and advance planning to accelerate evaluation, licensing and access to PREP.

“The concerns raised about the trials are serious, and there is a need for thorough and unbiased investigation,” said Mitchell Warren, AVAC Executive Director. “But all of the concerns raised are solvable. AVAC calls on researchers, communities and advocates to work together to ensure that ethical concerns are addressed, solutions are found, and the trials go forward.”

The AVAC report calls for a coordinated effort from the World Health Organization, UNAIDS, the trial sponsors and other organizations to ensure that research and trials are coordinated and progress in an accelerated fashion, and that additional research is carried out in an expedited fashion, to ensure that we will know as soon as possible if tenofovir is a safe and effective biomedical prevention intervention.

Warren added, “We need as many HIV prevention tools as possible, so research on vaccines, microbicides and other potential interventions must also be accelerated whether or not tenofovir proves appropriate for PREP.” “AVAC remains committed to our mission of accelerating development of an AIDS vaccine, but we are also committed to working in partnership with other advocates and researchers to advance ethical prevention research and ensure that the benefits are shared globally.”

The report is available online at www.avac.org and in print on request from [email protected].

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 vaccines against HIV/AIDS.

This special report and AVAC’s continuous policy analysis, advocacy, education and outreach work are made possible by the dedicated labor of AVAC advocates and support from the Bill & Melinda Gates Foundation, Broadway Cares/Equity Fights AIDS, the Ford Foundation, the International AIDS Vaccine Initiative, the Overbrook Foundation, Until There’s a Cure Foundation, the WHO-UNAIDS HIV Vaccine Initiative, and many generous individuals who have become AVAC Members. AVAC is an IRS-certified 501(c)3 tax exempt organization, and donations are tax deductible.

Press Release

A public statement from the Global Campaign for Microbicides and the AIDS Vaccines Advocacy Coalition on the impact of stopping Tenofovir trials in Cambodia and Cameroon

Recently clinical trials have been launched in Africa, Asia and the United States to explore the potential use of oral Tenofovir as a “once a day” pill to prevent HIV in uninfected individuals – an intervention known as pre-exposure prophylaxis (PREP). Yet concerns from a few activists opposed to these efforts have resulted in government decisions to halt the trials in Cambodia and Cameroon.

The decisions to halt the trials have generated a firestorm of controversy in the HIV/AIDS treatment, prevention, advocacy, and research communities. In both countries, the public allegations criticizing the trials were not completely evidence-based, and the media’s coverage was highly provocative. As a result, government decisions to stop the trials may have been premature.

Left unchecked, these forces threaten to undermine future trials. The cost is paid in people’s lives – the lives of those who might benefit from new technologies or treatments. This is not to say that unethical research should proceed. But derailing trials without high levels of evidence to support the claim that they are unethical, is a costly practice.

The Global Campaign for Microbicides and the AIDS Vaccines Advocacy Coalition (AVAC) are international networks of advocates who have worked to forge meaningful collaborations between researchers, communities and activists. Both organizations are committed to ensuring that as science proceeds, the public interest is protected and the rights and interests of trial participants, users, and communities are fully represented and respected. Good prevention research must be accelerated, must be ethical, must involve communities and must result in products accessible and acceptable to the people who need them most.
We are convinced that the concerns raised by those who oppose the trials are solvable and need not have resulted in stopping trials. Issues can and should be addressed by researchers and sponsors working collaboratively with local communities and governments. Controversy over the ethics of research is an opportunity to engage communities in partnership. As Gregg Gonsalves of Gay Men’s Health Crisis recently noted, shutting down an HIV prevention study “is not a victory – it is a defeat. A victory would have been to be able to craft a solution to fix the local study.”

In this spirit, the Global Campaign and AVAC are planning to generate various materials that accurately reflect current events, assist all stakeholders with working though these issues and provide specific recommendations to accelerate ethical development of new technologies. Among the materials we will produce are:
�    A fact-sheet designed to correct some of the common misperceptions and errors of fact that have been made in the course of public discussion of these trials. This fact sheet will be available on our websites (http://www.global-campaign.org/ and http://www.avac.org/) in the next few weeks.
�    A background document that attempts to articulate the basics about Tenofovir, the current PREP studies and the various issues involved will be available in early March.
�    Two on-the-ground case studies to document what actually happened in Cambodia and Cameroon from each sector’s perspective, to identify lessons learned that could help prevent similar situations in the future. This project is already underway, and we hope to have these materials available in the coming three months.

The following key principles are pivotal:
1.    The HIV pandemic creates an incredibly urgent demand for additional safe and effective tools with which to treat HIV infection and stop transmission. This can only be achieved by responsible, credible scientific studies.
2.    Research to create these tools must be done in a way that protects the rights of vulnerable populations and contributes to overcoming the global imbalance in access to health care resources.
3.    Communities affected by research must be actively involved in its conceptualization and implementation.
4.    The rights of trial participants should be respected and participants should be admired for their contribution to helping others.
5.    Researchers and funding agencies must be held accountable for their studies, and advocates must demand that problems be resolved.
6.    AVAC and the Global Campaign are dedicated to developing effective collaborations among a broad range of civil society actors, researchers and sponsors.
We cannot combat AIDS effectively without research and development of new technologies. Without clinical trials, we cannot know what does and does not work – or how different drugs and interventions work in various populations and settings. This means wrestling, collectively and collaboratively, with the complexities of designing trials that are simultaneously ethical and scientifically rigorous. Simply objecting to existing trial designs and shutting down trials is not a solution. We must, instead, proceed with the much harder job of shaping a research standard we can support and then demanding that trials be designed and adequately funded to meet that standard.

For more information:
�    AIDS Vaccine Advocacy Coalition (AVAC): Mitchell Warren, Executive Director, [email protected], +1 (212) 367-1084, http://www.avac.org/

�    Global Campaign for Microbicides: Lori Heise, Executive Director, [email protected], +1 (202) 822-0033, http://www.global-campaign.org/

Press Release

AIDS Advocates Partner to Involve African Americans in search for an AIDS vaccine

LOS ANGELES and NEW YORK, February 7, 2005 — In recognition of National Black HIV/AIDS Awareness Day, the AIDS Vaccine Advocacy Coalition (AVAC) and the Black AIDS Institute (the Institute) are pleased to announce the release of Myths About HIV Vaccines and Vaccine Research, a fact sheet that addresses misconceptions in African American communities about the search for a preventive HIV vaccine.

This fact sheet is part of a partnership between the Institute and AVAC to ensure that African Americans are involved in research efforts to develop vaccines for HIV/AIDS. The fact sheet is available on-line at http://www.blackaids.org/.

The US Centers for Disease Control and Prevention (CDC) reported 69% of women who tested HIV-positive between 2000 and 2003 were African American. Similarly, African American men had the highest rate of new HIV/AIDS diagnosis among all other racial/ethnic groups in 2003, seven times that of their white counterparts. For African Americans and all communities highly impacted by HIV/AIDS, an effective vaccine could make the difference between life and death.

“One thing we clearly learned from the first large-scale clinical trial of an experimental vaccine for HIV was that African Americans and other communities of color highly impacted by HIV must be represented,” said Edd Lee, AVAC’s Director of Community Education & Outreach.

Recognizing this, AIDS vaccines have been a core component of the Institute’s African American HIV University (AAHU) curriculum, ensuring African American AIDS experts are informed and prepared to tackle the issues of HIV vaccine research.

“This is a great example of how strategic partnerships can create needed resources for communities — AVAC brings expertise in AIDS vaccine research, we bring expertise in African American HIV capacity building, and in the end it is the community that benefits,” said Antonne Moore, Director of Programming for the Institute.

AAHU is a comprehensive training and internship program to decrease stigma and misperception and increase HIV science literacy in Black communities. The Institute is currently accepting applications for the next AAHU session. The deadline for submissions is February 11, 2005, and applications can be found at http://www.blackaids.org/.

About the Black AIDS Institute: The Institute’s mission is to stop the AIDS pandemic in Black communities by engaging and mobilizing Black institutions and individuals in efforts to confront HIV. The Institute interprets public and private sector HIV policies, conducts trainings, offers technical assistance, disseminates information and provides advocacy from a uniquely and unapologetically Black point of view.

About the AIDS Vaccine Advocacy Coalition (AVAC): AVAC is a not-for-profit, non-partisan community organization dedicated to accelerating the ethical development and global delivery of vaccines for HIV/AIDS. For more information, visit http://www.avac.org/.