A new rectal microbicide gel is being tested among men-who-have-sex-with-men and transgender people in Thailand to see if it can halt the spread of HIV.
The phase II human extended safety study began in Chiang Mai province in Thailand in February and is being conducted by the Research Institute for Health at Chiang Mai University and will be backed up by further trials in Bangkok, South Africa, Peru and in the United States.
Participants in the study will be given three different HIV prevention regimes with a one week gap between each regime.
The regimes are eight weeks of Pre-Exposure Prophylaxis (PrEP) with oral doses of Truavada, eight weeks of daily doses of a rectal gel containing glycerin and tenofovir designed to make the rectum a hostile environment for the HIV virus, and eight weeks of using a microbicide rectal gel designed to be used between 12 hours before and after sex.
The length of the trial for each participant is six months and there is no placebo group in the study given the dangers of contracting HIV.
Anyone who contracts HIV during the study will be given immediate treatment and any participant can opt out of the study at any point.
Research coordinator Pongpun Saokhieo told Citizen News Service that participants were also quizzed to ensure they understood the full risks of participating in the trial.
‘They also have to take a “test of understanding” – a set of 20 questions – and answer correctly at least 80% of them,’ Saokhieo said.
‘This ensures that they really understand the study and nurse counselors are available round-the-clock on [a] mobile phone helpline with whom they can seek help if any concern arises’
The phase II study will involve 24 LGBTI participants, with 13 of those already recruited and another 11 to be found by October.
Researchers hope to finish the study by the end of the first quarter of 2015.
If the gel proves successful it could be a game changer in fighting the spread of HIV among LGBTIs in Asia where in many countries the rate of infection among LGBTIs is around 5% and in some countries as high as 30%.