Clinical trialNCT00000878CompletedPhase 1Interventional

A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment26HIV InfectionsPregnancy

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to evaluate the safety and tolerance of 2 anti-HIV drugs, d4T and 3TC, given in combination to HIV-positive pregnant women and their infants. Most HIV-positive pregnant women usually take the anti-HIV drug zidovudine (ZDV) to treat HIV and reduce the chances of giving HIV to their babies. It recently has been shown that a combination of drugs may be more effective than ZDV alone. This study tests the effectiveness of combinations of ZDV, d4T, and 3TC.

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Investigators

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

Jash Unadkat
Study Chair
clinicaltrials.gov ↗
Nancy Wade
Study Chair
clinicaltrials.gov ↗
Salih Yasin
Study Chair
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Sandra Burchett
Study Chair
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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

20 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
Univ of Puerto Rico / Univ Children'S Hosp Aids
San Juan, Puerto Rico

United States

Harbor - Ucla Med Ctr / Ucla School of Medicine
Los Angeles, California, United States
Los Angeles County - Usc Med Ctr
Los Angeles, California, United States
Ucla Med Ctr / Pediatric
Los Angeles, California, United States
Howard Univ Hosp
Washington D.C., District of Columbia, 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 Chicago Children'S Hosp
Chicago, Illinois, United States
Brigham and Women'S Hosp
Boston, Massachusetts, United States
Children'S Hosp of Boston
Boston, Massachusetts, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States
Children'S Hosp at Albany Med Ctr
Albany, New York, United States
Suny Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Temple Univ School of Medicine
Philadelphia, Pennsylvania, United States
Regional Med Ctr at Memphis
Memphis, Tennessee, United States
Saint Jude Children'S Research Hosp of Memphis
Memphis, Tennessee, United States
Children'S Hospital & Medical Center / Seattle Actu
Seattle, Washington, 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.

Lamivudine →Stavudine →Zidovudine →

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: 31 Oct 2001
Last update posted: 29 Oct 2021
Registered enrollment: 26
Registry id: NCT00000878

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.