search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AS-101
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, ammonium trichloro(dioxoethylene-O,O'-)tellurute

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Arizona / Health Science Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00002266
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 1990
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, ammonium trichloro(dioxoethylene-O,O'-)tellurute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AS-101

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Univ of Arizona / Health Science Ctr
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs