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Clinical trialNCT00000862CompletedPhase 1Interventional

A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment36HIV InfectionsPregnancy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

To obtain a pharmacokinetic profile of oral ZDV and to determine whether the oral administration of Zidovudine (ZDV) during labor and delivery will provide a similar profile to that obtained with the use of IV ZDV in ACTG 082. To evaluate the tolerance of oral ZDV in this population, defined as the ability to take oral doses and lack of vomiting within 30 minutes of receiving oral study doses. The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not practical or feasible. Approximately 18% of the women in the ACTG 076 trial missed their IV ZDV infusions, even at experienced ACTG sites. There is an urgent need to establish a more practical method of delivering ZDV during labor and delivery that, at minimum, will approximate the rate of ZDV administration utilized in ACTG 082. In the future, this would enable women to start an intensive ZDV regimen during early labor, even prior to reaching the hospital.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico
  • San Juan City Hosp

    San Juan, Puerto Rico

United States
  • Ucsd Med Ctr / Pediatrics / Clinical Sciences

    La Jolla, California, United States

  • Ucla Med Ctr / Pediatric

    Los Angeles, California, United States

  • Ucsf / Moffitt Hosp - Pediatric

    San Francisco, California, United States

  • Univ of California, San Francisco

    San Francisco, California, United States

  • Univ of Florida Health Science Ctr / Pediatrics

    Jacksonville, Florida, United States

  • Univ of Miami (pediatric)

    Miami, Florida, United States

  • Univ of Miami / Jackson Memorial Hosp

    Miami, Florida, United States

  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp

    Newark, New Jersey, United States

  • Saint Jude Children'S Research Hosp of Memphis

    Memphis, Tennessee, United States

  • Children'S Hosp of the King'S Daughters

    Norfolk, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
—
Primary completion
—
Completion
30 Nov 2003
Last update posted
28 Oct 2021
Registered enrollment
36
Registry id
NCT00000862

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.