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

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002063
• Lead Sponsor: Glaxo Wellcome

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 1990-01
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (8)

Dr Gordon Dickinson; 🇺🇸 Miami, Florida, United States

Dr Gigi Diamond / New York Veterans Administration; 🇺🇸 New York, New York, United States

Veterans Affairs Med Ctr / Admin Only / Not For Patient Care; 🇺🇸 Durham, North Carolina, United States

Houston Veterans Administration Med Ctr; 🇺🇸 Houston, Texas, United States

Wadsworth Veterans Administration Med Ctr; 🇺🇸 Los Angeles, California, United States

Veterans Administration Med Ctr; 🇺🇸 Washington, District of Columbia, United States

San Francisco Veterans Administration Med Ctr; 🇺🇸 San Francisco, California, United States

Walter Reed Army Med Ctr; 🇺🇸 Washington, District of Columbia, United States