Experts gathered for UNAIDS, WHO meeting recommend follow-up studies of ARV-containing microbicide gel start soon

Sep 8 2010

Experts gathered at a joint meeting of UNAIDS and the WHO last week called for two additional clinical trials to test the effectiveness and safety of a microbicide vaginal gel containing the antiretroviral tenofovir, which previous studies have shown reduces the risk of HIV transmission in women who used it before and after sex by 39 percent, PANA/Afrique en ligne reports (9/5).

"The results of the first trial of the tenofovir-based gel, [conducted by the Centre for the AIDS Programme of Research in South Africa (CAPRISA)] … announced in July at the XVIII International AIDS Conference in Vienna, must be confirmed before the product can be made available for general use," U.N. News Centre reports.

The follow-up trials will build off of "[t]he CAPRISA study [which] was conducted in South Africa with women aged 18 to 40 years who used the gel once during the 12 hours before sex and once during the 12 hours after sex," the news service continues. One of the two trials, which will also be held in South Africa, will test the effectiveness of the microbicide in "sexually active 16- and 17-year-olds in settings where HIV incidence is high," according to the U.N. News Centre.

"The other study will be conducted in other African countries and examine if a different dosing schedule is safe and effective. It will test if a single application of the gel before sex, or failing that immediately after, is equally effective and safe as the original two-dose regimen," the news service adds (9/3).

According to VOA News, "The first trials are likely to get under way early next year. The next phase of the research is estimated to cost $100 million." The article includes comments by UNAIDS Chief Scientific Adviser Catherine Hankins (Schlein. 9/3).

Pharma Times, also reporting on the meeting, writes, "An ongoing trial being conducted by the Microbicides Trial Network, which is evaluating the same gel used daily, will generate additional data on safety and product use. Research in the communities where the CAPRISA 004 trial was carried out will look at how to best promote, distribute and monitor gel use through existing family planning facilities." The news service continues, "While participants at the meeting in Johannesburg agreed on research priorities for the tenofovir gel, concerns were expressed over the limited funding committed so far to carry forward the next phase of research" (Mansell, 9/7).

The New York Times reports that "about $58 million of the $100 million needed for follow-up research has been pledged, according to UNAIDS." The newspaper explores the perception that donor nations are rethinking their commitments because of "shifting global health priorities and tight finances," and how "[e]xperts say investing in AIDS prevention is fiscally far preferable to the costs for lifelong treatment." The article includes quotes from Stefano Bertozzi of the Bill & Melinda Gates Foundation, Nomfundo Eland of Treatment Action Campaign, Hankins of UNAIDS, and Mead Over of Center for Global Development (Dugger, 9/3).