biomedical HIV prevention trials

The iPrEx trial results from 11 sites in six countries (Peru, Ecuador, Brasil, USA, Thailand, and South Africa) provide proof of concept of the safety and partial effectiveness of oral antiretroviral drugs in preventing HIV acquisition in men who have sex with men. This study shows the potential effects of combination prevention approaches—combining consistent condom use, frequent HIV testing, counselling, and treatment of sexually transmitted infections with pre-exposure prophylaxis (PrEP) for maximum prevention gains. Drug levels confirmed that excellent pill-taking behaviour was clearly critical to protection. The trial was built on genuine, transparent, meaningful participatory processes with study participants and communities during the entire life-cycle of the trial, in line with published good participatory practice guidelines and ethical standards for biomedical HIV prevention trials. [UNAIDS/AVAC Good participatory practice guidelines for biomedical HIV prevention trials and UNAIDS/WHO Ethical considerations in biomedical HIV prevention trials]. In a rollover study that will commence soon, all study participants, including those in the placebo group, will now have access to the drug combination while researchers gather information, including about factors influencing pill-taking behaviour and how to improve it. Four other trials currently underway with people who inject drugs, women at higher risk of HIV exposure, and serodiscordant couples (where one partner is HIV-positive and the other is HIV-negative) will yield their results between 2011 and 2013. Many questions remain unanswered about the role that pre-exposure prophylaxis, whether in oral tablet from as in iPrEx or for topical application as in the 1% tenofovir gel tested in CAPRISA 004, could play in HIV prevention programming. UNAIDS and WHO are convening modelling groups, supporting 8 country consultations and, in partnership with Georgetown University and Imperial College, organising 5 regional consultations to explore the potential impact and acceptability of these new prevention technologies.