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Completed Not applicable Interventional

Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)

ClinicalTrials.gov ID: NCT00002063

Public ClinicalTrials.gov record NCT00002063. 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 Oct 9, 2026, 8:52 AM EDT

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

Brief summary

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

Primary: To determine the clinical effect of zidovudine (AZT) compared to placebo in terms of time to progression to AIDS (i.e., occurrence of major opportunistic infections, dementia, and malignancies) or death. Initial drug assignment will be changed to open-label AZT for patients who experience a sustained decline in CD4 lymphocyte concentration to less than 200 cells/mm3, but analysis will be based on initial treatment assignment. To determine the immunologic effect of AZT compared to placebo in terms of time to drop in CD4 lymphocyte concentration of at least 25 percent from baseline assessment. To determine the antiviral effect of AZT compared to placebo in eradicating or suppressing HIV. Secondary: To determine the effect of AZT compared to placebo on the immune status of HIV-infected patients by comparing lymphocyte profiles and indices. To determine the long-term toxicities of AZT compared to placebo in terms of abnormalities in BL, hepatic function, renal function, skin, gastrointestinal system, and central nervous system. To describe the natural history of AIDS related complex (ARC) in placebo patients in terms of initial CD4 lymphocyte concentration and the Walter Reed staging system.

Study identification

NCT ID
NCT00002063
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Glaxo Wellcome
Industry
Enrollment
Not listed

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
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
Not listed
Last update posted
Jun 24, 2005

United States locations

U.S. sites
8
U.S. states
6
U.S. cities
7
Facility City State ZIP Site status
Wadsworth Veterans Administration Med Ctr Los Angeles California 90073 —
San Francisco Veterans Administration Med Ctr San Francisco California 94121 —
Walter Reed Army Med Ctr Washington D.C. District of Columbia 203075001 —
Veterans Administration Med Ctr Washington D.C. District of Columbia 20422 —
Dr Gordon Dickinson Miami Florida 33136 —
Dr Gigi Diamond / New York Veterans Administration New York New York 10010 —
Veterans Affairs Med Ctr / Admin Only / Not For Patient Care Durham North Carolina 27705 —
Houston Veterans Administration Med Ctr Houston Texas 77030 —

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 NCT00002063, 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 Jun 24, 2005 · Synced Oct 9, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00002063 live on ClinicalTrials.gov.

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