AVAC: MDP 301 effectiveness trial finds no evidence that PRO 2000 microbicide reduces HIV infection

Funding and Support for HIV Prevention Research Must Continue

The Microbicides Development Programme announced earlier today that its MDP 301 effectiveness trial, which was conducted among almost 9,400 women in four African countries, found no evidence that the PRO 2000 microbicide reduces the risk of HIV infection.

Reacting to today's announcement, AVAC executive director Mitchell Warren said, "Of course, we are disappointed to hear these results, since we always hope that such a trial will actually prove effectiveness. Yet we are confident that MDP 301, because it was so well implemented, provides vital information to help researchers and communities move forward in the search for safe and effective microbicides."

Although this product had looked promising in animal studies and in earlier human studies, the MDP 301 trial provided a clear answer that this product does not work. "But it is just as clear that this is by no means the end of the line for microbicide research," Warren added. "Around the world today, thousands of researchers and trial participants are continuing the important work of discovering and testing other, more potent microbicide candidates as well as additional biomedical prevention options. Scientists, funders, advocates and others in the field must now ensure that key lessons learned from this trial are incorporated into developing better products and into planning for new trials."

A trial of this complexity and magnitude is a great accomplishment in the effort to stem the tide of the HIV pandemic. Everyone involved, especially the trial staff and volunteers, deserve thanks and credit for their dedicated efforts and important contributions.

"We especially want to thank the more than 9,300 heroic women who have participated in this trial. Each one of these volunteers and their communities made a significant contribution to HIV prevention research," Warren said. "As we move forward in our search for new HIV prevention options, researchers will need the help of tens of thousands more volunteers around the world. We hope that many more communities and individuals will follow in the footsteps of the MDP 301 trial participants."

While this trial did not result in an effective product, it was a successful trial - it gave a clear result, even if that result is disappointing. In many ways, this trial should serve as a model for future HIV prevention trials as it will provide critical scientific information as well as important lessons from the extensive social science component and the comprehensive community engagement and preparation undertaken by the trial staff. The principal investigators and trial staff developed several innovative integrated approaches for working with participants and communities to ensure retention in the trial and to track women's use of the product.

"The HIV prevention field must now take the lessons learned from this trial and apply those systematically to a rational plan for future microbicide development", said Polly Harrison, Director of the Alliance for Microbicide Development, an AVAC partner. "Such a plan must include broadening the pipeline of candidate microbicides; making strategic decisions about which candidates should go forward in human trials; and ensuring that there is adequate funding for the additional trials that will be needed in the coming years."

Warren and Harrison agree that the entire HIV prevention research field must commit to working together to share knowledge, new information and innovative ideas, and to ensuring that there is coordination across prevention research disciplines and among researchers, implementers and communities.

Today, there are many more HIV prevention options in large-scale trials, including vaccines, other microbicides with different mechanisms of action and oral pre-exposure prophylaxis (PrEP) - antiretroviral drugs being tested for prevention. Important results from these trials are anticipated in 2010 and beyond. In addition, in the last few years, clinical trials have also shown that medical male circumcision can be effective at preventing HIV infection in heterosexual men. More recently, in October, results from a large clinical trial with over 16,000 participants in Thailand provided evidence for the first time that it is possible to reduce the risk of HIV infection with a vaccine.

"We need to continue the drive for comprehensive HIV prevention," Warren added. "That means perfecting methods and ensuring access for all who need them 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, vaccines and PrEP; and planning to integrate these new interventions into combination programs."