|
|
|||
|
Family Health International |
|||
FHI Statement: Study Shows Microbicide Gel May Prevent HIV in Women -- February 9, 2009 |
|||
|
MONTREAL, Canada — The "HPTN 035" clinical trial, designed to assess the safety of two microbicide candidates and involving more than 3,000 women in southern Africa and the United States, has demonstrated for the first time the promise of a vaginal gel for preventing HIV infection in women. Women who used the gel, PRO 2000, were 30 percent less likely to become infected with the virus than those using no gel or an unmedicated (placebo) product, according to findings presented today at the Conference on Retroviruses and Opportunistic Infections (CROI). Although this finding was not statistically significant, the study is an important step forward for HIV prevention research. The clinical trial, conducted by African and US researchers in South Africa, Zimbabwe, Zambia, Malawi and the United States, was designed to assess the safety of PRO 2000 and BufferGel and to determine whether they showed sufficient promise for testing in a larger Phase III clinical study. "The entire field of HIV prevention research has been given a boost," said Ward Cates, MD, MPH, President of Research at Family Health International (FHI), which helped design and launch the trial in 2001. "This is the first major study to show that a vaginal gel may prevent HIV infection in women. As with any initial scientific finding, additional clinical data are needed to fully demonstrate the effectiveness of this product." Microbicides are intended to reduce or prevent the sexual transmission of HIV and other sexually transmitted infections when applied topically inside of the vagina or rectum. Several candidate microbicides are being tested in clinical trials, although none is yet approved or available for use. Earlier trials have yielded disappointing results or were stopped early. The study also found that PRO 2000 (at a 0.5 percent dose) was safe and that BufferGel was safe but had no detectable effect on preventing HIV infection. All participants were counseled on safe sex practices, provided with condoms, and tested and treated for sexually transmitted infections throughout the study. Study participants are being informed of the findings and counseled on the continued need to follow safe sex practices in order to avoid possible HIV exposure. The HPTN 035 study was conducted by researchers affiliated with the HIV Prevention Trials Network (HPTN) and the Microbicide Trials Network (MTN), international clinical trials networks established and funded in 1998 and 2006, respectively, by the National Institute of Allergy and Infectious Diseases (NIAID) with co-funding by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH) to evaluate HIV prevention interventions. Family Health International (FHI), based in Research Triangle Park, NC, served as the central coordinating and operations center for the study, which was designed and launched with the principal investigator, Dr. Salim S. Abdool Karim, pro vice-chancellor for research at the University of KwaZulu-Natal in Durban, South Africa, and director of the Center for the AIDS Program of Research in South Africa and other network partners. Family Health International developed the trial protocol and other study materials, helped obtain ethical and regulatory approvals, trained site study staff, and worked with the research team to assure study quality. In addition to Dr. Abdool Karim, other authors of the study presented February 9 at CROI were: Anne S. Coletti, Family Health International, Research Triangle Park, NC; Barbra Richardson, University of Washington, Seattle, WA; Benoit Mâsse, Fred Hutchinson Cancer Research Center, Seattle, WA; Gita Ramjee, South African Medical Research Council, Durban, South Africa; Irving Hoffman, University of North Carolina at Chapel Hill School of Medicine; Dr. Mike Chirenje, University of Zimbabwe; Taha Taha, Johns Hopkins University Bloomberg School of Public Health; Muzala Kapina, Centre for Infectious Disease Research in Zambia; Lisa Maslankowski, University of Pennsylvania; Estelle Piwowar-Manning, Johns Hopkins University; and Lydia Soto-Torres, NIAID, Division of AIDS. Currently, women comprise half of all people worldwide living with HIV. In sub-Saharan Africa, women represent nearly 60 percent of adults living with HIV, and in several southern African countries young women are at least three times more likely to be HIV-positive than young men. In most cases, women become infected with HIV through sexual intercourse with an infected male partner. Although correct and consistent use of male condoms has been shown to prevent HIV infection, women often cannot negotiate condom use with their male partners. An effective microbicide would provide women with an HIV prevention method they could initiate. For more information about the HPTN 035 clinical study, click here or here. About Family Health International |
|||
|
|||
