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Completed Phase 1 Interventional

The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children

ClinicalTrials.gov ID: NCT00000967

Public ClinicalTrials.gov record NCT00000967. 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 Sep 2, 2026, 4:36 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

Safety and Tolerance of Zidovudine and Interferon-Alpha in HIV-Infected Children

Brief summary

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

PRIMARY: To determine the maximum tolerated dose of interferon-alfa (IFN-A) alone and in combination with zidovudine (AZT); to assess the safety and tolerance of IFN-A alone and in combination with AZT. SECONDARY: To evaluate the effect of combination IFN-A and AZT on immunologic and virologic parameters; to determine whether the pharmacokinetic parameters of AZT are modified by the subcutaneous administration of IFN-A. AZT is effective in suppressing the progression of HIV infection in patients without symptoms or with AIDS or AIDS-related complex (ARC). However, use of AZT is limited by its frequent toxicity, which sometimes relates to the amount of drug given. Thus, a combination treatment of two drugs that work together may provide more effective and safer treatment. IFN-A is a drug that has antiviral effects and may work well with AZT.

Study identification

NCT ID
NCT00000967
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
52 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
3 Months to 17 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
Aug 31, 1996
Last update posted
Oct 28, 2021

Ends 1996

United States locations

U.S. sites
6
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
Cook County Hosp. Chicago Illinois 60612
Chicago Children's CRS Chicago Illinois 60614
Tulane/LSU Maternal/Child CRS New Orleans Louisiana 70112
BMC, Div. of Ped Infectious Diseases Boston Massachusetts 02118
NYU Med. Ctr., Dept. of Medicine New York New York 10016
St. Jude/UTHSC CRS Memphis Tennessee 38105

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 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00000967, 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 28, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00000967 live on ClinicalTrials.gov.

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