HIV Infections
Conditions
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, ammonium trichloro(dioxoethylene-O,O'-)tellurute, Zidovudine
Brief summary
To evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS related complex (ARC).
Interventions
DRUGZidovudine
DRUGAS-101
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed