Study population Location Route of HIV transmission Intervention Outcome Comments
CAPRIS A 0042 889 heterosexual women at high risk of infection, aged 18-40years South Africa Vaginal Coltally-dependent TFV 1% gel (two doses up to 12h precoitus and postcoitus) 39% protection; 54% protection calculated in participants using >80% of doses High TFV-DP concentration in vaginal and cervical tissue critical for efficacy
iPrEX4 2499 MSM at high risk of infection; approximately 70% of mixed ethnicity; mean age in TDF/FTC group 27-5years North and South America, Thailand, South Africa Rectal/penile Daily oral TDF/FTC 44% protection; 92% protection calculated for subjects with detectable drug concentrations High TFV-DP concentrations in rectal tissue might be critical for efficay
TDF25 1200 sexually active adults; 55% male, 45% female; 94% unmarried; approximately 90% age 21-29years Botswana vaginal/penile Daily oral TDF/FTC 63% protection >30% did not complete study; cannot draw definitive conclusions for women and men separately
PIP6 4747 heterosexual serodiscordant couples; 38% negative-female, 68% negative-male partner, 98% married; median age 33years Botswana, Kenya, Rwanda, South Africa, Tanzania, Uganda, zambia vaginal Daily oral TDF or TDF/ FTC 62% protection with TDF alone; 73% protection with TDF/FTC Discordant couples may be a distinct, unique population
FEM-PrEP7 1951 heterosexual women at high risk of infection aged 18-35 years Kenya, South Africa, Tanzania vaginal Daily oral TDF/FTC Trail discontinued for futility in April, 2011 Adherence assessment with monthly clinical samples to measure drug concentration is pending
VOICE (MTN-003)3 5029 heterosexual women aged 18-45 years Uganda, South Africa, Zimbabwe vaginal Daily oral TDF or daily oral TDF/FTC or daily topical TFV gel Oral TDF group discontinued for futility in September, 2011; TFV 1% gel and placebo gel groups discontinued for futility in November, 2011; oral TDF/FTC group continues For TDF, the tissue concentration may be critical; for TFV 1% gel, adherence analysis is pending
HPTN 0521 1763 heterosexual serodiscordant couples; 50% negative- females, 50% negative-male partner; 94% married; 61% aged 26-40 years Bostwana, Kenya, Malawi, South Africa, Zimbabwe, Brazil, India, Thailand Vaginal/Penile Immediate or delayed ART in HIV-infected partner 96% protection Suppression of viraemia on therapy assured by routine monitoring
MSM=Men who have Sex with Men. TDF=Tenofovir Disoproxil Fumarate. TFV=Tenofovir. TFV-DP= Tenofovir Diphosphate. FTC=Emtricitabine. ART= Antiretroviral Therapy
Table 1: Antiretroviral-based HIV Prevention Studies.
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