Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)
NCT00002063 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Zidovudine
Study Locations (8)
California
- Wadsworth Veterans Administration Med Ctr — Los Angeles
- San Francisco Veterans Administration Med Ctr — San Francisco
District of Columbia
- Walter Reed Army Med Ctr — Washington D.C.
- Veterans Administration Med Ctr — Washington D.C.
Florida
- Dr Gordon Dickinson — Miami
New York
- Dr Gigi Diamond / New York Veterans Administration — New York
North Carolina
- Veterans Affairs Med Ctr / Admin Only / Not For Patient Care — Durham
Texas
- Houston Veterans Administration Med Ctr — Houston
Trial Details
| Field | Value |
|---|---|
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002063
The ClinicalTrials.gov registry entry for NCT00002063 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Glaxo Wellcome, which has 18 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention — of which Zidovudine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00002063 reports 8 study locations spanning 6 distinct geographic areas — top geographies include California, District of Columbia, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00002063 about?
NCT00002063 is a clinical study titled "Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)". 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...
What is the current status of trial NCT00002063?
This trial is currently completed. It is a NA study.
What conditions does trial NCT00002063 study?
This clinical trial studies the following conditions: HIV Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00002063?
The interventions under investigation include: Zidovudine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00002063?
This trial is sponsored by Glaxo Wellcome, which has 18 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00002063 being conducted?
This trial has 8 study locations across California, District of Columbia, Florida, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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