Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycobacterium Avium-Intracellulare Infection; HIV Infections
Intervention: Trifluridine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Amgen
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.
Clinical Details
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 design: Treatment, Open Label, Safety Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
New York Hosp - Cornell Med Ctr, New York, New York 10021, United States
Additional Information
Last updated: June 23, 2005
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