Table 3.
Pre-exposure prophylaxis trials in humans.
| Study | Sponsor | Product | Population | Countries | Enrollment started | Status/ anticipated results |
|---|---|---|---|---|---|---|
| West Africa TDF Trial | FHI | Daily oral TDF | 936 heterosexual women | Ghana, Cameroon, Nigeria | 2004 | Completed |
| US Extended TDF Safety Trial | CDC | Daily oral TDF | 400 MSM | USA | 2005 | Completed |
| Bangkok TDF Study | CDC | Daily oral TDF | 2400 IDUs | Thailand | 2005 | Fully enrolled/2010 |
| TDF-2 | CDC | Daily oral TDF/FTC (switched from TDF in 2007) | 1200 heterosexual men and woman | Botswana | 2007 | Fully enrolled/2011 |
| iPrEX | NIH, BMGF | Daily oral TDF/FTC | 3000 MSM | Peru, Ecuador, Brazil, USA, Thailand, South Africa | 2007 | Fully enrolled/2011 |
| Partners PrEP | BMGF | Daily oral TDF Daily oral TDF/FTC |
3900 heterosexual HIV-discordant couples | Kenya, Uganda | 2008 | Enrolling/2012 |
| FEM PrEP | FHI, USAID | Daily oral TDF/FTC | 3900 high-risk heterosexual women | Malawi, Uganda, South Africa, Zambia, Zimbabwe | 2009 | Enrolling/2012 |
| VOICE (MTN 003) | NIH | Daily oral TDF Daily oral TDF/FTC Daily vaginal TFV gel |
4950 heterosexual women | Malawi, South Africa, Uganda, Zambia, Zimbabwe | 2009 | Enrolling/2013 |
BMGF: Bill & Melinda Gates Foundation; CAPRISA: Centre for the AIDS Programme of Research in South Africa; FHI: Family Health International; FTC: Emtricitabine; IAVI: International AIDS Vaccine Initiative; IDU: Intravenous drug user; iPrEX: Pre-exposure prophylaxis initiative; MSM: Men who have sex with men; MTN: Microbicide Trial Network; TDF: Tenofovir disoproxil fumarate; TFV: Tenofovir; VOICE: Vaginal and oral interventions to control the epidemic.
Adapted from [24].