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

NCT ID: NCT00002290

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Zidovudine

Intervention Type: DRUG

Acyclovir

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glaxo Wellcome

INDUSTRY

Sponsor Role: lead

Locations

Birmingham Veterans Administration Med Ctr / Univ of Alabama

Birmingham, Alabama, United States

Univ of Arizona / Health Science Ctr

Tucson, Arizona, United States

ViRx Inc

San Francisco, California, United States

Georgetown Univ Med Ctr / Main Hosp 4

Washington D.C., District of Columbia, United States

Veterans Administration Med Ctr

Bay Pines, Florida, United States

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Harper Hosp

Detroit, Michigan, United States

Univ of Pennsylvania / HIV Clinic

Philadelphia, Pennsylvania, United States

Vanderbilt School of Medicine

Nashville, Tennessee, United States

Univ TX Galveston Med Branch

Galveston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Univ of Utah School of Medicine

Salt Lake City, Utah, United States

Univ of Virginia Health Sciences Ctr

Charlottesville, Virginia, United States

Richmond AIDS Consortium

Richmond, Virginia, United States

Countries

United States

Other Identifiers

03

Identifier Type: -

Identifier Source: secondary_id

018A

Identifier Type: -

Identifier Source: org_study_id