For Immediate Release
October 25, 2010
FDA and CONRAD Chart U.S. Regulatory Path for 1% Tenofovir Gel for
Collaborative meeting held with key stakeholders
Arlington, VA – – The U.S. Food and Drug Administration (FDA) held an end-of-Phase II
meeting to determine the next steps required for U.S. licensure of 1% tenofovir gel, a
microbicide product recently found to be effective at reducing the rate of HIV and herpes infection
in women when used before and after sex.
The meeting, held on October 20, 2010, was requested by CONRAD, a division of the Eastern
Virginia Medical School in Norfolk, VA. CONRAD was one of the partners in the Phase II
study, “CAPRISA 004,” which evaluated 1% tenofovir gel in prevention of male-to-female HIV
transmission in 889 women in South Africa. USAID provided funding for the trial, conducted
by the Centre for Programme Research for AIDS in South Africa and U.S. based FHI, which was
the first study to show that a vaginal gel can reduce the risk of HIV and herpes infection in
women. CONRAD manufactured and provided the tenofovir gel for the study.
Tenofovir gel was found to be 39% effective in reducing a woman’s risk of becoming infected
with HIV during sex and 51% effective in preventing genital herpes infections in the women
participating in the trial. Results of the CAPRISA 004 clinical trial were reported in July 2010
and represent the first “proof of concept” for a vaginal microbicide.
A number of key stakeholders contributed to the collaborative meeting with the FDA, including
representatives from the U.S. National Institutes of Health, the U.S. Agency for International
Development, Gilead Sciences, Microbicides Trial Network (MTN), South African clinical
investigators, the International Partnership for Microbicides (IPM) and FHI.
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