A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

HIV Infections Clinical Trial

Official title:

A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001995
• Other study ID #: 048C
• Secondary ID: CS 087065
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1992
• 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 determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Zidovudine (AZT).

• Didanosine (ddI).

Patients must have the following:

• Diagnosis of AIDS as defined by the CDC.

• Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).

• Provide written informed consent.

Prior Medication:

Allowed:

• If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.

• Required:

• Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Known hypersensitivity to any of the study drugs.

Concurrent Medication:

Excluded:

• Other therapy for mycobacterial disease.

Patients with the following are excluded:

• Known hypersensitivity to any of the study drugs.

Prior Medication:

Excluded within 4 weeks:

• Therapy for mycobacterial disease.

• Antiretroviral drugs, other than zidovudine (AZT) or ddI.

• Investigational drugs, other than ddI.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Rifabutin

Locations

Country	Name	City	State
United States	Infectious Disease Physicians Inc	Annandale	Virginia
United States	Infectious Disease Research Consortium of Georgia	Atlanta	Georgia
United States	Dr Alfred F Burnside Jr	Columbia	South Carolina
United States	Nassau County Med Ctr	East Meadow	New York
United States	Ctr for Special Immunology	Fort Lauderdale	Florida
United States	TheraFirst Med Ctrs Inc	Fort Lauderdale	Florida
United States	Bay Harbor Hosp	Harbor City	California
United States	Mem Hosp Hollywood	Hollywood	Florida
United States	Ctr for Special Immunology	Irvine	California
United States	Research Med Ctr	Kansas City	Missouri
United States	Southwest Community Based AIDS Treatment Group - COMBAT	Los Angeles	California
United States	Miami Veterans Administration Med Ctr	Miami	Florida
United States	Milwaukee County Med Complex	Milwaukee	Wisconsin
United States	Dr Frank Rhame	Minneapolis	Minnesota
United States	Chelsea Village Med Ctr / Saint Vincent's Hosp	New York	New York
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Maricopa County Med Ctr	Phoenix	Arizona
United States	AIDS Community Research Consortium	Redwood City	California
United States	HIV Research Group	San Diego	California
United States	Davies Med Ctr	San Francisco	California
United States	San Francisco Veterans Administration Med Ctr	San Francisco	California
United States	Veterans Administration Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacia

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dautzenberg B, Castellani P, Truffot-Pernot CH, Leng B, Sassella D. Bacteriological assessment of rifabutin versus placebo for M. avium bacteremia in AIDS patients. Int Conf AIDS. 1996 Jul 7-12;11(1):117 (abstract no MoB1359)