Washington : A vaginal gel to prevent HIV infection has shown encouraging results in a clinical trial conducted on women in Africa and the US.
Findings of the recently concluded study, funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, were presented at the Conference on Retroviruses and Opportunistic Infections underway in Montreal.
Investigators found microbicide gel PRO 2000 safe and approximately 30 percent effective, as gel, foam or cream, which when applied to vaginal or anal orifice, may prevent male-to-female sexual transmission of HIV infection.
“Although more data are needed to conclusively determine whether PRO 2000 protects women from HIV infection, the results of this study are encouraging,” said NIAID director Anthony S. Fauci.
The Phase II/IIb clinical trial, which enrolled more than 3,000 women, is NIH’s first large clinical study of a microbicide.
“The study, while not conclusive, provides a glimmer of hope to millions of women at risk for HIV, especially young women in Africa,” added lead investigator Salim S.A. Karim, from the Centre for the AIDS Program of Research in South Africa.
“It provides the first signal that a microbicide gel may be able to protect women from HIV infection,” he said.
Currently, women make up 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, said an NIAID release.
A separate clinical study sponsored by the Medical Research Council (MRC) and the Department for International Development of Britain that is currently testing PRO 2000 (0.5 percent dose) in preventing HIV infection among women in Africa could provide further insight into the microbicide’s effectiveness.
That Phase III study involving nearly 9,400 women is set to conclude in August 2009.