A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients

Inclusion Criteria Concurrent Medication: Required: Zidovudine (AZT). Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis. Allowed ONLY with permission of the Wyeth-Ayerst medical monitor: Standard therapy for infections that develop during the study period. Oral acyclovir. Nystatin. Ketoconazole. Immunomodulators. Specific therapy for malignancies (including Kaposi's sarcoma). Patients must have the following: Diagnosis of AIDS or AIDS related complex (ARC). Provide informed written consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Active opportunistic infection or malignancy requiring treatment at study entry. Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data. Evidence of central nervous system (CNS) opportunistic infection or malignancy. Serious underlying medical problems, including insulin- dependent diabetes mellitus, unstable ASHD (atherosclerotic heart disease) or uncontrolled hypertension, which may complicate interpretation of treatment results. Dementia. Evidence of = or > 2 + proteinuria at study entry. Concurrent Medication: Excluded without permission of the Wyeth-Ayerst medical monitor: Immunomodulators. Specific therapy for malignancies (including Kaposi's sarcoma). Patients with the following are excluded: Active opportunistic infection or malignancy requiring treatment at study entry. Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data. Evidence of conditions listed in the Patient Exclusion Co-existing Conditions. Active substance abuse. Unlikely or unable to comply with the requirements of the protocol. Prior Medication: Excluded within 8 weeks of study entry: Immunomodulators. Antiviral therapy, except zidovudine. Excluded within 2 weeks of study entry: Intravenous or oral acyclovir. Excluded within 3 months of study entry: Ribavirin. Required: Zidovudine at a dose of = or > 1000 mg/day for at least 6 weeks prior to study entry. Active substance abuse.