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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00002013

Collaborator

(none)

Location

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Zidovudine Drug: AS-101	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.