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

Wyeth

Status: Completed

Conditions: HIV Infections

Treatments: Drug: AS-101; Drug: Zidovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002013

753A-109-US

045C

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.