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

June 23, 2005 updated by: Glaxo Wellcome

A Multi-Center, Double-Blind Trial to Evaluate the Safety and Efficacy of Concurrent Retrovir (Zidovudine) and Zovirax (Acyclovir) Therapy in Patients With Early Symptomatic Human Immunodeficiency Virus (HIV) Infection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Birmingham Veterans Administration Med Ctr / Univ of Alabama
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Univ of Arizona / Health Science Ctr
    • California
      • San Francisco, California, United States, 94103
        • ViRx Inc
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr / Main Hosp 4
    • Florida
      • Bay Pines, Florida, United States, 33504
        • Veterans Administration Med Ctr
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Harper Hosp
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ of Pennsylvania / HIV Clinic
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt School of Medicine
    • Texas
      • Galveston, Texas, United States, 77550
        • Univ TX Galveston Med Branch
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Univ of Utah School of Medicine
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Univ of Virginia Health Sciences Ctr
      • Richmond, Virginia, United States, 23219
        • Richmond AIDS Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have:

  • Early AIDS related complex (ARC).
  • Willingness to be followed by the original study center for the duration of the trial (96 weeks).
  • Ability to give informed consent.
  • Patients may have associated lymphadenopathy (lymph nodes greater than or equal to 1 cm in two noncontiguous areas).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
  • Fever > 102 degrees F persisting for more than 14 consecutive days or more than 15 days in a 30-day interval, present at entry.
  • Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or > 6 loose stools per day accompanied by significant weight loss).

Concurrent Medication:

Excluded:

  • Acyclovir (ACV) therapy for chronic or recurrent herpes simplex.

Patients with an AIDS-defining indicator disease as outlined by the CDC surveillance definition for AIDS which includes opportunistic infections or neoplasms, HIV neurologic disease, AIDS dementia or the "wasting syndrome" are excluded.

Prior Medication:

Excluded within 4 weeks of study entry:

  • Any other experimental therapy.
  • Drugs which cause significant bone marrow suppression.
  • Rifampin or rifampin derivatives.
  • Cytolytic chemotherapy.
  • Drugs which cause significant nephrotoxicity or hepatotoxicity.
  • Immunomodulating agents, including steroids, interferon, Isoprinosine, immunoglobulin or interleukin 2.
  • Excluded within 8 weeks of study entry:
  • Antiretroviral agents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

February 1, 1990

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 018A
  • 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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