CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed
Drug / intervention
Zidovudinedrug
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/NCT00000960
NCT00000960Phase 3Completed

A Phase III Randomized Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerance of Oral Zidovudine (AZT) in Pregnant HIV Infected Women and Their Infants

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 31, 2001·Updated Oct 29, 2021

In Brief

A Phase 3 clinical trial evaluating Zidovudine for HIV Infections and Pregnancy. Completed, across 62 sites in 2 countries.

Detailed Summary

To determine whether the rate of HIV transmission from mother to infant can be reduced by continuous oral zidovudine (AZT) treatment to HIV infected pregnant women, intravenous AZT during childbirth, and oral AZT treatment of the newborn infant from birth to six weeks of age. The study is also designed to evaluate the safety of AZT for both the pregnant woman and the newborn infant. No method exists to prevent transmission of HIV from an infected mother to her newborn infant. Giving an antiviral agent (such as AZT) to the mother and to the newborn could in theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to maternal virus, or by preventive treatment of the fetus before exposure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
CollaboratorsGlaxo Wellcome

Timeline

Phase 3CompletedFinished
1994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2001
Study CompletionJun 1, 1994
TodayJul 2, 2026
Posted 24.8 years ago

Interventions

Zidovudinedrug