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

Study Overview
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Brief Summary
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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).

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Zidovudine
* Drug: AS-101


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zidovudine|nan|
|Drug: AS-101|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, ammonium trichloro(dioxoethylene-O,O'-)tellurute, Zidovudine