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On Tuesday, South African and US officials announced a bilateral initiative to support a Phase III trial of a microbicide that contains the AIDS drug tenofovir. The Technology Innovation Agency, which is licensing the African rights to the microbicide from the US research group CONRAD, plans to manufacture and distribute the product, if proved effective, with the local firm Cipla Medpro.
The confirmatory Phase III trial seeks to build on the results of a study of 900 women from two sites in KwaZulu-Natal province. That trial showed that a gel containing 1 percent tenofovir, used before and after sex, reduced HIV transmission risk by 39 percent. In addition, the microbicide halved the risk of acquiring herpes, an STD that increases vulnerability to HIV.
However, those results had a wide margin of error, and HIV protection efficacy was estimated to range from 6 percent to 60 percent, said professor Helen Rees, protocol chair of the Follow-on African Consortium for Tenofovir Studies (FACTS), which hopes to build on last year’s study and satisfy regulators of the microbicide’s safety and efficacy.
FACTS is being funded by $18 million from the US Agency for International Development and 70 million rand (US $10.2 million) from the South African Department of Science and Technology.
Pharmaceutical imports are the fifth-largest contributor to South Africa’s trade deficit, so the government is eager to see more of these goods produced domestically.
The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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