Expired Study
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Tucson, Arizona 85724


Purpose:

To compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or AIDS related complex (ARC) patients.


Criteria:

Inclusion Criteria Concurrent Medication: Allowed: - Standard therapy for infections. - Acyclovir. - Ganciclovir. - Allowed only with permission of Wyeth-Ayerst medical monitor: - Zidovudine (AZT). - Immunomodulators. - Specific therapy for malignancies (including Kaposi's sarcoma). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Evidence of severe liver dysfunction (serum albumin < 3 g/dl, SGOT or SGPT > 5 x upper limit of normal, prothrombin time > 15 seconds), or gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorder other than abnormalities secondary to AIDS or AIDS related complex (ARC). - Evidence of AIDS-related central nervous system involvement. - Disseminated Kaposi's sarcoma. Concurrent Medication: Excluded without permission of Wyeth-Ayerst medical monitor: - Zidovudine (AZT). - Immunomodulators. - Specific therapy for malignancies (including Kaposi's sarcoma). Patients with the following are excluded: - Evidence of major system abnormalities other than abnormalities secondary to AIDS or AIDS related complex. - Concomitant conditions as specified in Patient Exclusion Co-existing Conditions. - Unlikely or unable to comply with the requirements of the protocol. Prior Medication: Excluded within 4 weeks of study entry: - Systemic antiviral agents. - Immunosuppressive agents. - Immune stimulators such as BCG vaccine, isoprinosine, or other immunomodulators. Patients must: - Have a diagnosis of AIDS or AIDS related complex (ARC). - Demonstrate intolerance or refusal to take zidovudine (AZT). - Provide written informed consent.


NCT ID:

NCT00002266


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Tucson, Arizona 85724
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 25, 2017

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