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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002037
• Other study ID #: 062B
• Secondary ID: IFNG-8701
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: May 1991
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infection
• Mycobacterium Avium-Intracellulare Infection
• Mycobacterium Infections

Intervention

Drug:
• Trifluridine

Locations

Country	Name	City	State
United States	New York Hosp - Cornell Med Ctr	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States,