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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Ammonium trichloro(dioxoethylene-O,O'-)tellurate; Zidovudine

Criteria

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.