Table 2.
Trial | Study population | Preexposure prophylaxis | Current status |
---|---|---|---|
Bangkok Tenofovir Study (CDC1) | 2400 IVDU in Bangkok, Thailand | Oral daily TDF | Fully enrolled. Trial results expected in 2012 |
iPrEx Rollover Study (NIH,2 BMGF3) | 2500 MSM in multiple countries | Oral daily FTC/TDF in all HIV-negative patients from original iPrEx | 44% reduced risk of infection in FTC/TDF group. Rollover study results expected early 2013 |
TDF2 (CDC) | 1200 heterosexual men and women in Botswana | Oral daily FTC/TDF | TDF with 62% protective efficacy. Full data awaiting publication |
Partners PreP (BMGF) | 4700 serodiscordant heterosexual couples in Kenya and Uganda | Oral daily TDF or oral FTC/TDF | TDF with 62% protection efficacy and FTC/TDF with 73% protection efficacy. Full results expected 2013 |
VOICE4 (MTN5 003) | 4200 heterosexual women in various countries in Africa | Topical TDF vaginal gel* or oral TDF** or oral FTC/TDF | Results expected 2013 |
PreP in Young MSM (ATN6 082) | 99 young MSM | Oral FTC/TDF | Data collected. Analysis ongoing. |
ADAPT (HPTN7 067) | 360 participants (MSM and heterosexual women) in South Africa and Thailand | Oral FTC/TDF (daily dosing, time-driven dosing, event-driven dosing) | Enrolling (phase II trial) |
HPTN 069 | 400 MSM in the United States | MVC or MVC/FTC or MVC/TDF or FTC/TDF | In development (phase II trial) |
IPERGAY (ANRS8) | 300 MSM in France and Canada | Oral FTC/TDF with intermittent dosing | Enrolling |
Notes: Vaginal gel arm discontinued early due to review of interim data showing predicted lack of efficacy compared to placebo;
TDF arm discontinued early due to review of interim data showing predicted lack of efficacy compared to placebo.
Abbreviations: CDC, Centers for Disease Control; IVDU, intravenous drug user; TDF, tenofovir; NIH, National Institute of Health; BMGF, Bill and Melinda Gates Foundation; MSM, men who have sex with men; FVC, emtricitabine; VOICE, Vaginal and Oral Interventions to Control the Epidemic; MTN, Microbicide Trials Network; ADAPT, Alternative Dosing to Augment PrEP pill-Taking; ATN, Adolescent Trials Network; HPTN, HIV Prevention Trials Network; ANRS, Agence Nationale de Recherches sur le Sida et les Hépatites Virales.