At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 4,758 enrolled
Drug / intervention
Tenofovir Disoproxil Fumarate (TDF) +2 moredrug
Likely dose
Tenofovir Disoproxil Fumarate (TDF) 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
In Brief
A Phase 3 clinical trial evaluating Tenofovir Disoproxil Fumarate (TDF), Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), and 1 other intervention for HIV-1 Infections and HIV Infections. Completed, enrolled 4,758 participants across 9 sites in 2 countries.
Detailed Summary
Randomized, blinded, placebo-controlled trial to demonstrate if pre-exposure prophylaxis decreases HIV-1 acquisition among HIV-1 uninfected individuals within HIV-1 discordant couples.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infections, HIV Infections
CountriesKenya, Uganda
CollaboratorsBill and Melinda Gates Foundation
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2007
Enrollment StartMay 2008
Primary CompletionOct 2013
TodayJul 2026
First PostedNov 12, 2007
Enrollment StartMay 1, 2008
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 18.6 years ago
Interventions
Tenofovir Disoproxil Fumarate (TDF)drug
TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)drug
FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebodrug
Placebo TDF \& Placebo FTC/TDF, 1 tablet each daily.