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Table 2 Pre-Exposure Prophylaxis Trials in Progress.

From: Update on microbicide research and development-seeking new HIV prevention tools for women

Trial Name (Number) Phase Description Location Sponsor No. of Subjects Population Intervention(s) Results Expected
FEM-PrEP III Safety & effectiveness Kenya, South Africa, Tanzania, Zimbabwe FHI, USAID, BMGF 3900 Heterosexual women Daily oral TDF/FTC Q3 2013
iPrEs III Safety & effectiveness Brazil, Ecuador, Peru, South Africa, Thailand, US NIH, BMGF 2499 Men who have sex with men Daily oral TDF/FTC Q4 2010 [39]
Partners PrEP III Safety & effectiveness Kenya, Uganda BMGF 4700 Serodiscordant heterosexual couples Daily oral TDF; daily oral TDF/FTC Ql 2013
Bangkok Tenofovir Study (CDC 4370) II/III Safety & effectiveness Thailand CDC 2400 Injection drug users Daily oral TDF Ql 2012
VOICE (MTN 003) IIB Safety & effectiveness South Africa, Uganda, Zimbabwe MTN, NIH 5000 Heterosexual women Daily oral TDF; daily oral TDF/FTC; daily topical tenofovir gel Ql 2013
PrEP in YMSM (ATN 082) II Safety, acceptability, & feasibility US ATN, NICHD 99 Young men who have sex with men Daily oral TDF/FTC Q2 2011
TDF2 (CDC 4940) II Safety & adherence Botswana CDC 1200 Heterosexual men and women Daily oral TDF/FTC Q2 2011
IAVI E001 & E002 I/II Safety, acceptability, & adherence Kenya, Uganda IAVI 150 Serodiscordant couples and men and women Daily oral TDF/FTC; intermittent oral TDF/FTC (twice weekly + coital dosing) Q4 2010
TMC278-TiDP15-C158* I Safety, tolerance & pharmaco-kinetics UK Tibotec Pharmaceucals 100 Men and women TMC278LA injected IM Ql 2011
  1. ATN = Adolescent Medicine Trials Network; BMGF = Bill & Melinda Gates Foundation; CDC = US Centers for Disease Control and Prevention; FHI = Family Health International;
  2. FTC = emtricitabine; IAVI = International AIDS Vaccine Initiative; MTN = Microbicide Trials Network; NICHD = National Institute of Child Health & Human Development;
  3. NIH = US National Institutes of Health; TDF = tenofovir disoproxil fumerate; USAID = United States Agency for International Development; YMSM = young men who have sex with men
  4. Reference: http://www.avac.org/ht/d/sp/a/GetDocumentAction/i/3113 (accessed december 1, 2010)
  5. *Reference: http://www.clinicaltrials.gov/ct2/show/NCT01031589?term=tmc278la%26rank=3 (accessed december 1, 2010)