Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
Completed · Not applicable
Conditions studied: Mycobacterium Avium-Intracellulare Infection, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002037
- Run by
- Amgen
- People needed
- 15
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- New York Hosp - Cornell Med Ctr — New York, New York, United States
Full record on ClinicalTrials.gov
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