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.


Study is Available At:


Original ID:

045B


NCT ID:

NCT00002266


Secondary ID:

753A-103-US


Study Acronym:


Brief Title:

An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients


Official Title:

An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:December 1990
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:AS-101

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Wyeth

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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