CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 780 enrolled
Drug / intervention
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) +2 moredrug
Likely dose
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) 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/NCT03386578
NCT03386578Phase 2Completed
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Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention During Pregnancy and Postpartum in Adolescents and Young Women and Their Infants

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 29, 2017·Updated Feb 19, 2025

In Brief

A Phase 2 clinical trial evaluating Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF), Behavioral HIV risk reduction package, and 1 other intervention for HIV Infections. Completed, enrolled 780 participants across 7 sites in 4 countries.

Detailed Summary

The purpose of this study was to evaluate the pharmacokinetics, feasibility, acceptability, and safety of a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) as oral daily pre-exposure prophylaxis (PrEP) to prevent HIV during pregnancy and postpartum in adolescents and young women and their infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesMalawi, South Africa, Uganda, Zimbabwe
CollaboratorsGilead Sciences

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 29, 2017
Enrollment StartJul 3, 2018
Primary CompletionOct 25, 2023
Study CompletionFeb 24, 2024
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 8.5 years ago

Interventions

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)drug

200 mg/300 mg of FTC/TDF administered orally as a fixed-dose combination tablet once daily

Behavioral HIV risk reduction packagebehavioral

Included cohort-appropriate SMS messages.

Enhanced adherence supportbehavioral

Included two-way SMS messaging and tailored counseling with drug level feedback.