The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002290
• Lead Sponsor: Glaxo Wellcome

Brief Summary

This double-blind, placebo-controlled study is designed to determine the long-term safety and efficacy of concurrent oral Retrovir / Zovirax (AZT and ACV) therapy and oral AZT therapy alone, in the treatment of early symptomatic HIV infection. Efficacy will be evaluated by monitoring the incidence, severity, and time of development of opportunistic infections and other manifestations of advanced symptomatic HIV infection. The effects of the combination and single AZT therapy on immune function and viral replication will also be evaluated. Study participants will be monitored for evidence of toxicity or intolerance to concurrent AZT / ACV administration and AZT therapy alone.

Detailed Description

Not available

Study Timeline

• Status Verified: 1990-02
• 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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (14)

ViRx Inc; 🇺🇸 San Francisco, California, United States

Rush Presbyterian - Saint Luke's Med Ctr; 🇺🇸 Chicago, Illinois, United States

Harper Hosp; 🇺🇸 Detroit, Michigan, United States

Univ of Utah School of Medicine; 🇺🇸 Salt Lake City, Utah, United States

Richmond AIDS Consortium; 🇺🇸 Richmond, Virginia, United States

Georgetown Univ Med Ctr / Main Hosp 4; 🇺🇸 Washington, District of Columbia, United States

Veterans Administration Med Ctr; 🇺🇸 Bay Pines, Florida, United States

Univ of Pennsylvania / HIV Clinic; 🇺🇸 Philadelphia, Pennsylvania, United States

Univ of Arizona / Health Science Ctr; 🇺🇸 Tucson, Arizona, United States

Birmingham Veterans Administration Med Ctr / Univ of Alabama; 🇺🇸 Birmingham, Alabama, United States

Vanderbilt School of Medicine; 🇺🇸 Nashville, Tennessee, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Univ TX Galveston Med Branch; 🇺🇸 Galveston, Texas, United States

Univ of Virginia Health Sciences Ctr; 🇺🇸 Charlottesville, Virginia, United States