CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 122 enrolled
Drug / intervention
Tenofovir disoproxil fumarate +2 moredrug
Likely dose
Not stated in 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/NCT00120471
NCT00120471Phase 1Completed
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A Phase I Open Label Trial of the Safety and Pharmacokinetics of Tenofovir Disoproxil Fumarate in HIV-1 Infected Pregnant Women and Their Infants

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 18, 2005·Updated Nov 1, 2021

In Brief

A Phase 1 clinical trial evaluating Tenofovir disoproxil fumarate for HIV Infections. Completed, enrolled 122 participants across 5 sites in 2 countries.

Detailed Summary

To prevent mother-to-child transmission (MTCT) of HIV in resource-limited countries, a simple yet effective treatment plan is needed. Tenofovir disoproxil fumarate (TDF) is an anti-HIV drug approved for use in the United States for the treatment of HIV infected adults. The purpose of this study is to determine the safety, tolerability, and blood levels of TDF in HIV infected pregnant women and their babies. The study will be conducted at sites in Malawi and Brazil.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBrazil, Malawi
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 18, 2005
Enrollment StartNov 1, 2006
Primary CompletionOct 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 21.0 years ago

Interventions

Tenofovir disoproxil fumaratedrug

600-mg tablet taken orally once daily

Tenofovir disoproxil fumaratedrug

4-mg/kg oral suspension taken at birth and on Days 3 and 5 after birth

Tenofovir disoproxil fumaratedrug

6-mg/kg oral suspension taken at birth and daily for 7 days after birth