Trial of HIV-prevention gel enters final phase
The final 24-month trial of a gel that researchers hope will help prevent HIV transmission is expected to start at the end of July or early August.
Wits Professor Helen Rees, of the university’s reproductive health and HIV institute, said in Pretoria that the R300-million trial will involve about 2 200 sexually active women at seven locations countrywide.
The tenofovir gel study—known as the Follow-on African Consortium for Tenofovir Studies (Facts)—is a follow-up to the Caprisa 004 study that showed a highly consistent use of the microbicide by women resulted in a 59% reduction in the risk of HIV infection.
The Facts study will see the participants, aged between 18 and 30, using the gel 12 hours before intercourse and within 12 hours after intercourse.
The results of the study are expected to be released by the end of 2013. It is being funded by the department of science and technology, the United States government and various other organisations, including the Bill and Melinda Gates Foundation.
The Facts study aims to confirm the findings of the Caprisa 004 study, which involved a smaller sample of women at only two locations.
The Caprisa (Centre for the Aids Programme of Research in South Africa) study began in May 2007, was completed in December 2009, and the data collected from the study was published in March 2010.
US ambassador to South Africa Donald Gips announced that his government will contribute R129-million over the next three years toward the study, while Deputy Minister of Science and Technology Derek Hanekom said his department will be contributing R70-million to the study. These are the two largest contributors but several other organisations are also funding the project.
Hanekom said that because South Africa has the highest HIV infection rate it also needs to be at the forefront of research to prevent the spread of the virus.
Rees said that women who are pregnant will not be participating in the trial, but it is an area that needs to be researched because they are at an increased risk of contracting the disease. “Most pregnant women do not think of using a condom,” she said.—Sapa