Table 1.
Current Clinical Trials of PrEP
| Trial Name | Population | Location | Drug | Means of Administration |
Sample Size |
Expected Results |
|---|---|---|---|---|---|---|
| US Extended Safety Trial (CDC* 4323) | Gay men; MSM | United States | TDF | Daily oral | 400 | TDF is safe and well-tolerated as PrEP for MSM |
| iPrEX | Gay men; MSM | Brazil, Ecuador, Peru, South Africa, Thailand, United States | TDF/FTC | Daily oral | 2500 | Fully enrolled 2009; results probable by late 2010 |
| Bangkok Tenofovir Study (CDC 4370) | Injecting drug users | Thailand | TDF | Daily oral | 2400 | Completed enrollment 2010; possible results 2010/early 2011 |
| CAPRISA 004 | Heterosexual women | South Africa | TDF | Coitally dependent topical vaginal gel | 1000 | First demonstration of the efficacy of tenofovir gel |
| TDF2 (CDC 4940) | Heterosexual men and women | Botswana | TDF/FTC | Daily oral | 1200 | Enrollment stopped 2009; safety data likely 2010 |
| Partners PrEP | Serodiscordant heterosexual couples | Kenya, Uganda | TDF and TDF/FTC | Daily oral | 3900 | Enrolling; data expected 2012 |
| FEM-PrEP | Heterosexual women | Kenya, Malawi, South Africa, Tanzania, Zambia | TDF/FTC | Daily oral | 3900 | Enrolling; data expected 2013 |
| VOICE (MTN 003) | Heterosexual women | South Africa, Uganda, Zambia, Zimbabwe; additional sites to be determined | TDF; TDF/FTC | Daily oral (TDF, TDF/FTC) Daily topical vaginal gel (TDF) |
5000 | Enrolling; data expected 2013 |
| ATN 082 | High-risk young MSM | United States | TDF/FTC | Daily dosing with or without a behavioral intervention | 100 | Enrolling; results in 2011 or 2012 |
| Studies Involving Intermittent PrEP (i-PrEP) | ||||||
| IAVI E001 and E002 | Serodiscordant couples and at-risk men and women | Kenya, Uganda | TDF/FTC | Daily oral; intermittent oral (twice weekly + coital dosing) | 150 | Full enrollment expected 2010 |
| HPTN 066 | Low-risk men and women | United States | TDF/FTC | Different dosing strategies planned | 48 | Intense pharmacokinetic study; full enrollment expected 2010 |
| HPTN 067 | High-risk women and MSM | Thailand, South Africa | TDF/FTC | Fixed interval vs coitally dependent | 360 | In planning stages |
*
CDC denotes Centers for Disease Control and Prevention; FTC, emtricitabine; MSM, men who have sex with men; TDF, tenofovir; IAVI, the International AIDS Vaccine Initiative; and HPTN, the HIV Prevention Trials Network.