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Completed Phase 1 Interventional

A Study to Test the Safety, Tolerance, and Metabolism of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy in Newborn Infants Born to HIV-1 Infected Women

ClinicalTrials.gov ID: NCT00000864

Public ClinicalTrials.gov record NCT00000864. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 2:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase I Study of Safety, Tolerance, and Pharmacokinetics of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy In Neonates Born to HIV-1 Infected Women

Study identification

NCT ID
NCT00000864
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Enrollment
60 participants

Conditions and interventions

Conditions

Interventions

  • Abacavir sulfate Drug
  • Zidovudine Drug

Drug

Eligibility (public fields only)

Age range
1 Day to 28 Days
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Dec 31, 2000
Last update posted
Oct 27, 2021

Ends 2001

United States locations

U.S. sites
12
U.S. states
9
U.S. cities
11
Facility City State ZIP Site status
UAB, Dept. of Ped., Div. of Infectious Diseases Birmingham Alabama 35233
Usc La Nichd Crs Los Angeles California 90033
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS Los Angeles California 900951752
UCSD Maternal, Child, and Adolescent HIV CRS San Diego California
Univ. of Florida Jacksonville NICHD CRS Jacksonville Florida 32209
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases Atlanta Georgia 30306
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds. Chicago Illinois 60612
HMS - Children's Hosp. Boston, Div. of Infectious Diseases Boston Massachusetts 021155724
SUNY Upstate Med. Univ., Dept. of Peds. Syracuse New York 13210
Bronx-Lebanon Hosp. IMPAACT CRS The Bronx New York 10457
DUMC Ped. CRS Durham North Carolina 277103499
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases Charleston South Carolina 294253312

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00000864, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 27, 2021 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00000864 live on ClinicalTrials.gov.

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