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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
ClinicalTrials.gov processed this data on August 23, 2015
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: Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

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

Page last updated: August 23, 2015

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