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

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.