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NCT00002063 · ClinicalTrials.gov registry record · NA

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

A NA study of HIV Infections, sponsored by Glaxo Wellcome.

Completed
Registry status
NA
Development phase
8
Study locations

NCT00002063 is a NA study of HIV Infections that has completed, run by Glaxo Wellcome. The trial reports 8 study locations across 6 states.

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The verdict

NCT00002063, a NA study of HIV Infections, has completed, sponsored by Glaxo Wellcome.

COMPLETED
Registry status
NA
Development phase
8
Study locations

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

FieldValue
Phase NA

Sponsor

Glaxo Wellcome

65 total trials

What the Registry Record Tells You About NCT00002063

The ClinicalTrials.gov registry entry for NCT00002063 describes a study currently listed as completed, categorized as NA. 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 65 total studies on file at ClinicalTrials.gov.

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.

NCT00002063 reports 8 study locations spanning 6 distinct geographic areas - top geographies include California, District of Columbia, Florida.

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.

What interventions are being tested in trial NCT00002063?

The interventions under investigation include: Zidovudine (DRUG).

Who is sponsoring clinical trial NCT00002063?

This trial is sponsored by Glaxo Wellcome, which has 65 total clinical trials registered on ClinicalTrials.gov.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.