CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,219 enrolled
Drug / intervention
Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg +1 moredrug
Likely dose
Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 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.

Search/NCT00448669
NCT00448669Phase 3Completed
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Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana

Centers for Disease Control and Prevention·interventional·Posted Mar 19, 2007·Updated Feb 5, 2020

In Brief

A Phase 3 clinical trial evaluating Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg and Placebo Oral Tablet for HIV Infections. Completed, enrolled 1,219 participants across 2 sites in 2 countries.

Detailed Summary

This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBotswana, United States
CollaboratorsBotswana Ministry of Health, Gilead Sciences

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 19, 2007
Enrollment StartMar 1, 2007
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 19.3 years ago

Interventions

Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mgdrug

Placebo Oral Tabletdrug