PRETORIA, South Africa—With the entire adult entertainment industry embroiled in conflict over whether adult content performers in California will be forced to use condoms, dental dams, rubber gloves and face shields during the production of sexually explicit material, there's welcome news on the horizon: A second trial study has begun on Tenofovir gel, a microbicide which has shown promise in preventing transmission of HIV and Herpes Simplex 2 during genital/genital contact.
During the International AIDS Conference held in July, 2010 in Vienna, the Centre for the AIDS Programme of Research in South Africa (CAPRISA) had announced that a gel containing 1 percent Tenofovir which the program had been testing had been shown to be 39 percent effective in preventing the transmission of HIV to female receptive partners. Better still, last October, the U.S. Food and Drug Administration agreed that with the release of full data from the CAPRISA study, the agency would "fast track" approval of the drug for use in the U.S..
The "fast track" designation means that a new drug application for use of the product can be submitted as a "rolling review," meaning that a researcher conducting clinical trials can submitted his/her results for FDA review in sections as they are completed, rather than being forced to wait until all sections of the application's review process are completed. This could result in the gel being made available to the public months or years more quickly than the usual review process.
However, the FDA requires two well-controlled studies before approving a product, and the second Tenofovir gel study has just been commenced at the University of Pretoria in South Africa.
That study, known as the Follow-on African Consortium for Tenofovir Studies (FACTS) study, is being funded by the university's science and technology department, the U.S. government and several other organizations, including the Bill and Melinda Gates Foundation, and is being conducted by Prof. Helen Rees of the university's Reproductive Health and HIV Institute. The study will involve about 2,200 sexually active South African women, aged 18-30, who will use the gel 12 hours befor eintercourse and within 12 hours afterwards. It is expected to be completed sometime in 2013.
During an interview, Prof. Rees noted an interesting side-effect of the study of another anti-HIV gel, which proved to be unsuccessful in preventing transmission, but which improved participants' sexual pleasure.
"One of the big messages we got was, many women said, 'We liked this'," Prof. Rees stated.
It is unknown whether the Tenofovir gel will produce similar pleasurable results.