A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients

Exclusion Criteria

• •Active drug or alcohol abuse.
• •Concurrent Medication:
• •Excluded:
• •Any chronic systemic medications.
• •Aspirin.
• •Cimetidine.
• •Flurazepam.
• •Indomethacin.
• •Ranitidine.
• •Probenecid.
• •Excluded during first 2 weeks of study:
• •Any chronic ( \> 3 days) medication.
• •Acetaminophen and other drugs that are metabolized by hepatic glucuronidation.
• •Prior Medication:
• •Excluded:
• •Zidovudine (AZT) at any time.
• •Excluded within 14 days of study entry:
• •Other experimental therapy.
• •Drugs which cause neutropenia or significant nephrotoxicity.
• •Rifampin or rifampin derivatives.
• •Systemic anti-infectives.
• •Excluded within 30 days of study entry:
• •Immunomodulating agents.
• •Excluded within 3 months of study entry:
• •Any antiretroviral agent.
• •Patients may not have any of the following:
• •A gastrointestinal disturbance which may impair oral absorption.
• •Chronic persistent candidiasis.
• •An opportunistic infection or malignancy fulfilling the definition of AIDS-associated disease.
• •Patients with symptoms suggestive of an opportunistic infection should be evaluated within 30 days of starting drug.
• •Patients may not have any of the following:
• •A gastrointestinal disturbance which may impair oral absorption.
• •Chronic persistent candidiasis.
• •An opportunistic infection or malignancy fulfilling the definition of AIDS-associated disease.
• •Patients with symptoms suggestive of an opportunistic infection should be evaluated within 30 days of starting drug.
• •All patients will have positive antibody for HIV confirmed by any federally licensed ELISA test kit; if ELISA is negative, eligibility will be confirmed by a positive Western blot.
• •All patients will have evidence of HIV infection in the plasma as indicated by circulatory p24 antigen within 30 days prior to study entry.
• •The symptomatic HIV infection required for inclusion is defined as at least one of the following:
• •Temperature \> 38.0 degrees C persisting for more than 14 consecutive days or more than 15 days in a 30-day interval prior to study entry without definable cause.
• •Diarrhea, defined as = or \> 3 liquid stools per day, persisting for more than 1 month prior to entry into the study without definable cause.
• •Weight loss greater than 10 percent of body weight noted in a 120-day period prior to entry into the study.
• •Patients with persistent generalized lymphadenopathy (PGL), defined as lymph node enlargement greater than 1 cm in diameter at two or more noncontiguous extrainguinal sites, who in addition to this adenopathy have constitutional symptoms such as intermittent fever (\> 38 degrees C for less than 15 days/month), sweats, malaise, and/or fatigue will also be eligible. This patient population has to have T4 cell counts = or \< 500. Potential enrollees with PGL must have two screening lymphocyte subset determinations, at least 72 hours apart, within 3 months of entry that fall in the appropriate T4 range (200 - 500 cells/mm3). If an otherwise eligible subject has one screening T4 count in the appropriate range and one that is outside this range, a third screening count will determine eligibility.