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

Condition(s) targeted: HIV Infections

Intervention: Zidovudine (Drug); Acyclovir (Drug)

Phase: N/A

Status: Completed

Sponsored by: Glaxo Wellcome

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.

Official title: 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

Study design: Treatment, Double-Blind

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Birmingham Veterans Administration Med Ctr / Univ of Alabama, Birmingham, Alabama 35233, United States

Univ of Arizona / Health Science Ctr, Tucson, Arizona 85724, United States

ViRx Inc, San Francisco, California 94103, United States

Georgetown Univ Med Ctr / Main Hosp 4, Washington, District of Columbia 20007, United States

Veterans Administration Med Ctr, Bay Pines, Florida 33504, United States

Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States

Harper Hosp, Detroit, Michigan 48201, United States

Univ of Pennsylvania / HIV Clinic, Philadelphia, Pennsylvania 19104, United States

Vanderbilt School of Medicine, Nashville, Tennessee 37232, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Univ TX Galveston Med Branch, Galveston, Texas 77550, United States

Univ of Utah School of Medicine, Salt Lake City, Utah 84132, United States

Univ of Virginia Health Sciences Ctr, Charlottesville, Virginia 22908, United States

Richmond AIDS Consortium, Richmond, Virginia 23219, United States

Last updated: June 23, 2005