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.

Condition	Treatment or Intervention
HIV Infections	Drug: Zidovudine  Drug: Acyclovir

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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.

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

Study ID Numbers:  018A; 03
Record last reviewed:  February 1990
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002290
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08