A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients

You may not be if

• 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.