Table 3.
Ongoing PrEP trials
| Location | Sponsor/Funder | Population (Mode of exposure) | PrEP being tested | Status (Expected completion) | phase |
|---|---|---|---|---|---|
| United States | CDC-4323 | 400 gay men and other men who have sex with men (penile/rectal) | TDF (daily, oral) | Fully enrolled (Q32010) | Phase 2, safety |
| Thailand | CDC-4370 | 2400 injecting drug users (parenteral) | TDF (Daily,oral) | Enrolling (Q4,2010) | Phase 2,3 Safety, efficacy |
| South Africa | CAPRISA, FHI, CONRAD,US AID,LIFElab | 900 heterosexual women (vaginal) | Tenofovir 0.1%gel (topical,vaginal) | Fully enrolled (Q3 2010) | Phase 2 Safety and effectiveness |
| Botswana | CDC-4940 | 1200 heterosexual men and women (penile and vaginal) | TDF/FTC (switched from TDF Q1 2007) (daily,oral) | Fully enrolled (Q4 2010) | Phase 2 Safety, adherence |
| Brazil, Ecuador, Peru, US, SA, Thailand (iPrEX Study) | NIH, BMGF | 3000 gay men and other men who have sex with men (penile/rectal) | TDF/FTC (Daily,oral) | Fully enrolled (Q4 2010) | Phase 3 Safety and efficacy |
| Kenya, Uganda (Partners PrEP Study) | BMGF | 3900 serodiscordant heterosexual couples (penile and vaginal) | TDF; TDF/FTC (daily oral) | Enrolling (2013) | Phase 3, safety and efficacy |
| Kenya, Malawi, South Africa, Tanzania (FEM-PrEP) | FHI, USAID | 3900 high-risk women (vaginal) | TDF/FTC (daily oral) | Enrolling (2012) | Phase 3 Safety and effectiveness |
| South Africa; Uganda, Zambia, Zimbabwe (VOICE study) | NIH MTN-003 | 4200 sexually active women (vaginal) | TDF; TDF/FTC; TDF gel | Enrolling (2013) | Phase 2b Safety and effectiveness |
| Kenya Uganda | IAVI E001 and E002 | 150 serodiscordant couples, men and women. | TDF/FTC (daily/intermittent, oral) | Fully enrolled (Q42010) | Phase 1,2 Safety, acceptability, adherence |
| USA | PrEP in YMSM ATN 082 | 99 YMSM | TDF/FTC (daily,oral) | Enrolling (2011) | Phase 2, safety, acceptability, adherence |
| UK | St Stephens AIDS TRust | PrEP using TMC 278LA 100 men and women | TMC278LA (intramuscular) | Enrolling (2011) | Phase 1,2 Safety and Pharmaco-kinetics. |
ATN: Adolescent Medicine Trials Network for HIV/AIDS Interventions
BMGF: Bill and Melinda Gates Foundation
CAPRISA: Centre for the AIDS Program of Research in South Africa
CDC: US Centers for Disease Control
FHI: Family Health International
IAVI: International AIDS Vaccine Initiative
MTN: Microbicide Trials Network
USAID: US Agency for International Development
NIH: US National Institute of Health
LA: Long acting