Expired Study
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Los Angeles, California 90033


Purpose:

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).


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.


NCT ID:

NCT00002013


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90033
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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