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Gay Star News reported that Thailand’s Research Institute for Health at Chiang Mai University was conducting a phase II human extended safety study to determine if an anal lubricant containing anti-HIV drugs could prevent HIV transmission among men who have sex with men and transgender people in Thailand. South Africa, Bangkok, Peru, and the United States also would conduct trials to confirm the effectiveness of the regimen.
Study participants would receive three, eight-week HIV prevention regimens with a one-week gap between each regimen over the six-month trial. The first regimen would provide pre-exposure prophylaxis with oral doses of Truvada. The second regimen would provide daily doses of a glycerin and tenofovir rectal gel that made the rectum a “hostile environment for the HIV virus.” The third regimen would provide a microbicide rectal gel for participants’ use between 12 hours before and after sex. No participants would receive placebo during any phase of the trial.
Research coordinator Pongpun Saokhieo emphasized that investigators counseled potential participants to ensure they understood the risks inherent in the trial. The study required participants to answer correctly at least 80 percent of a quiz designed to test their understanding of the trial. Participants could opt out of the trial at any time and would receive immediate treatment if any participants contracted HIV during the study. The trial would provide a mobile phone helpline staffed by nurse counselors who could answer participants’ questions.
The study already has recruited 13 lesbian, gay, bisexual, transgender, or intersex (LGBTI) participants and would enlist another 11 prior to the trial’s beginning in October. Researchers aimed to complete the trial by the end of March in 2015. Many Asian countries reported approximately 5 percent HIV prevalence among LGBTIs, and some countries estimated up to 30 percent HIV prevalence among LGBTIs.