Table 2 Current and Proposed Pre-Exposure Prophylaxis Trials, October 2007 Study (Sponsor) Study and Agent(s) (Dose) Population (Target N) Sites [52].
From: Prevention of the sexual transmission of HIV-1: preparing for success
Study (sponsor) | Study and Agent(s) (Dose) | Population (Target N) | Sites |
|---|---|---|---|
US CDC-NCHSTP-4323 | Phase II daily TDF or daily oral placebo | MSM ages 18 to 60 (400) | US (anticipated completion 2009) |
US CDC-NCHSTP-4370 | Phase II/III daily TDF or daily oral placebo | IDU ages 20 to 60 (2,000) | Thailand (anticipated completion 2008) |
CDC-NCHSTP-4940; BOTUSA MB06 | Phase III daily Truvada or daily oral placebo | Men and women ages 18 to 29 (1,200) | Botswana (anticipated completion 2010) |
iPrEX (NIAID/BMGF) | Phase III daily Truvada or daily oral placebo | MSM ages 18 and up (3,000) | Peru, Ecuador, Brazil, Thailand, South Africa, US (anticipated completion 2011) |
FHI (USAID) | ) Phase III daily Truvada or daily oral placebo | High-risk women ages 18 to 35 (3,900) | Kenya, Malawi, South Africa, Tanzania, Zimbabwe (study planned, no anticipated completion date yet) |
Partners Study (BMGF) | Phase III daily TDF, daily Truvada, or daily oral Placebo | Discordant heterosexual couples ages 18 to 60 (4,000) | Uganda, Kenya (study planned, no anticipated completion date yet) |
VOICE/MTN 003 (NIAID) | Phase IIB safety and effectiveness of daily tenofovir gel (1%) or placebo gel, or daily TDF (300 mg), Truvada, or oral placebo | Nonpregnant premenopausal women ages 18 to 35 (2,400 oral, 1,600 gel) | South Africa, Zambia, Malawi, Uganda, Zimbabwe (study planned, no anticipated completion date yet) |