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

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March 24, 2005

 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 avac@avac.org.

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.