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Completed Phase 1 Interventional

A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)

ClinicalTrials.gov ID: NCT00000701

Public ClinicalTrials.gov record NCT00000701. 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 Nov 10, 2026, 8:42 PM EST

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The study is designed to test the drug zidovudine (AZT) in children, including study of drug levels in various parts of the body fluids, safety of the drug, and its effect on different parts of the body. The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children.

Study identification

NCT ID
NCT00000701
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
12 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
3 Months to 12 Years
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
Feb 1990 (Actual)
Last update posted
Nov 3, 2021

Ends 1990

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Univ of Miami School of Medicine Miami Florida 331361013 —
Duke Univ Med Ctr Durham North Carolina 27710 —

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

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00000701, 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 Nov 3, 2021 · Synced Nov 10, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00000701 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →