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The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants

NCT00000960 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1496

Last updated 2021-10-29

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Pregnancy

Interventions

DRUG

Zidovudine

Sponsors & Collaborators

  • Glaxo Wellcome

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • E Connor

  • R Sperling

Study Design

Purpose
TREATMENT

Eligibility

Min Age
1 Day
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
1994-06-30

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000960 on ClinicalTrials.gov