Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Trifluridine

About this trial

This is an interventional treatment trial for Mycobacterium Avium-Intracellulare Infection focused on measuring AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Interferon-gamma, Recombinant, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients must have: Diagnosis of AIDS and persistent Mycobacterium avium- intracellulare (MAI) bacillemia. Life expectancy of at least 3 months. Baseline chest X-ray and EKG (electrocardiogram). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Known hypersensitivity to interferons or other exogenous lymphokine. History of cardiac abnormality or disease. History of hypertension. Patients with the following are excluded: Known hypersensitivity to interferons or other exogenous lymphokine. History of cardiac abnormality or disease. History of hypertension. Prior Medication: Excluded within 4 weeks of study entry: Corticosteroids. Anti-inflammatory medication (except aspirin). Changes in the dose of anti-mycobacterial drugs. Immune agents. Prior Treatment: Excluded within 4 weeks of study entry: Radiotherapy. Risk Behavior: Excluded: Intravenous drug abuse.

Sites / Locations

New York Hosp - Cornell Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002037

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00002037

Brief Title

Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study

Official Title

Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 1991

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

Amgen

4. Oversight

5. Study Description

Brief Summary

To examine the effectiveness of subcutaneous gamma interferon in reducing severity of Mycobacterium avium- intracellulare (MAI) bacillemia episodes in AIDS patients in an open-label dose-randomized multi-center pilot clinical investigation. To evaluate the safety of gamma interferon given by subcutaneous injection (SC) in the AIDS patient in the presence and absence of AZT therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mycobacterium Avium-Intracellulare Infection, HIV Infections

Keywords

AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Interferon-gamma, Recombinant, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Masking

None (Open Label)

Enrollment

15 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Trifluridine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria Patients must have: Diagnosis of AIDS and persistent Mycobacterium avium- intracellulare (MAI) bacillemia. Life expectancy of at least 3 months. Baseline chest X-ray and EKG (electrocardiogram). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Known hypersensitivity to interferons or other exogenous lymphokine. History of cardiac abnormality or disease. History of hypertension. Patients with the following are excluded: Known hypersensitivity to interferons or other exogenous lymphokine. History of cardiac abnormality or disease. History of hypertension. Prior Medication: Excluded within 4 weeks of study entry: Corticosteroids. Anti-inflammatory medication (except aspirin). Changes in the dose of anti-mycobacterial drugs. Immune agents. Prior Treatment: Excluded within 4 weeks of study entry: Radiotherapy. Risk Behavior: Excluded: Intravenous drug abuse.

Facility Information:

Facility Name

New York Hosp - Cornell Med Ctr

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Mycobacterium Avium-Intracellulare Infection, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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