CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 66 enrolled
Drug / intervention
Emtricitabine/Tenofovir disoproxil fumarate +1 moredrug
Likely dose
Emtricitabine/Tenofovir disoproxil fumarate 900 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/NCT00076791
NCT00076791Phase 1Completed
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A Phase I Study of the Safety, Tolerance, and Pharmacokinetics of Tenofovir Disoproxil Fumarate (TDF) and the Combination of TDF Plus Emtricitabine in HIV-1 Infected Pregnant Women and Their Infants

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Feb 6, 2004·Updated Nov 1, 2021

In Brief

A Phase 1 clinical trial evaluating Emtricitabine/Tenofovir disoproxil fumarate and Tenofovir disoproxil fumarate for HIV Infections. Completed, enrolled 66 participants across 12 sites in 2 countries.

Detailed Summary

Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal transmission) become infected during labor and delivery. The purpose of this study is to test the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or emtricitabine/TDF (FTC/TDF) given at the time of labor to HIV infected pregnant women and to their newborn infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, United States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2004
Enrollment StartMar 1, 2004
Primary CompletionMar 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 22.4 years ago

Interventions

Emtricitabine/Tenofovir disoproxil fumaratedrug

900 mg of TDF combined with 600 mg emtricitabine

Tenofovir disoproxil fumaratedrug

600 mg oral dose of TDF