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NCT00076791 · ClinicalTrials.gov registry record · Phase 1

Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
66
Enrollment target

NCT00076791 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 66 participants.

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The verdict

NCT00076791, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
66 participants
Enrollment target

Study 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.

Interventions

  • DRUG Tenofovir disoproxil fumarate
  • DRUG Emtricitabine/Tenofovir disoproxil fumarate

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2004-03
Est. Completion 2011-03
Phase Phase 1

What the Registry Record Tells You About NCT00076791

The ClinicalTrials.gov registry entry for NCT00076791 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Tenofovir disoproxil fumarate is the first listed.

NCT00076791 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00076791 about?

NCT00076791 is a clinical study titled "Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants". 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) giv...

What is the current status of trial NCT00076791?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2004-03. Estimated completion is 2011-03.

What interventions are being tested in trial NCT00076791?

The interventions under investigation include: Tenofovir disoproxil fumarate (DRUG), Emtricitabine/Tenofovir disoproxil fumarate (DRUG).

Who is sponsoring clinical trial NCT00076791?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.