Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial

HIV Infections Clinical Trial

Official title:

Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002267
• Other study ID #: 048B
• Secondary ID: 087027-999
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 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

The primary objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200, as compared to placebo, and to assess if survival is prolonged in patients who receive rifabutin prophylaxis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Patients must have the following:

• Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC).

• Written informed consent obtained, which must include a statement that treatment may involve risks to the embryo or fetus, which are currently unforeseeable, if the subject becomes pregnant.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI).

• Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation.

Concurrent Medication:

Excluded:

• Antiretroviral agents other than zidovudine (AZT).

• Didanosine (ddI).

• Antimycobacterial therapy.

• Rifampin.

• Isoniazid.

• Clofazimine.

• Ethambutol.

• Cycloserine.

• Ethionamide.

• Amikacin.

• Ciprofloxacin.

• Streptomycin.

• Other investigational drugs.

• If antimicrobial therapy is required to treat bacterial infections (= or < 14 days), Adria Laboratories must be contacted prior to initiation of therapy.

Patients with the following are excluded:

• Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI).

• Previous or current Mycobacterium avium complex (MAC) infection.

• Perceived patient unreliability or unavailability for frequent monitoring.

Prior Medication:

Excluded within 4 weeks of study entry:

• Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI).

• Antimycobacterial therapy.

• Rifampin.

• Isoniazid.

• Clofazimine.

• Ethambutol.

• Cycloserine.

• Ethionamide.

• Amikacin.

• Ciprofloxacin.

Required:

• Zidovudine (AZT).

• Antipneumocystis prophylactic therapy.

Required for at least 4 weeks prior to study entry:

• Zidovudine (AZT) or didanosine (ddI).

• Antipneumocystis prophylaxis.

Study Design

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
Canada	Univ of Calgary Health Science Ctr	Calgary	Alberta
Canada	Univ of Alberta/Division of Inf Dis/Dept of Med	Edmonton	Alberta
Canada	Victoria Gen Hosp	Halifax	Nova Scotia
Canada	McMaster Univ Med Ctr	Hamilton	Ontario
Canada	Dr Emil Toma / Hotel Dieu de Montreal	Montreal	Quebec
Canada	Montreal Chest Institute	Montreal	Quebec
Canada	Montreal Gen Hosp	Montreal	Quebec
Canada	Ottawa Gen Hosp	Ottawa	Ontario
Canada	Mount Sinai Hosp	Toronto	Ontario
Canada	Saint Michael's Hosp	Toronto	Ontario
Canada	Sunnybrook Health Science Ctr	Toronto	Ontario
Canada	Saint Paul's Hosp	Vancouver	British Columbia
United States	Albany Veterans Administration	Albany	New York
United States	Univ of New Mexico Hlth Sciences Ctr / Dept of Med	Albuquerque	New Mexico
United States	Infectious Disease Physicians Inc	Annandale	Virginia
United States	East Bay AIDS Ctr	Berkeley	California
United States	Pacific Oaks Med Group	Beverly Hills	California
United States	AIDS Services Erie County Med Ctr	Buffalo	New York
United States	AIDS Research Alliance - Chicago	Chicago	Illinois
United States	Northwestern Univ Med School	Chicago	Illinois
United States	Dr Alfred F Burnside Jr	Columbia	South Carolina
United States	Comprehensive AIDS Alliance of Detroit / Harper Hosp	Detroit	Michigan
United States	Community Research Initiative of South Florida	Miami	Florida
United States	Miami Veterans Administration Med Ctr	Miami	Florida
United States	Milwaukee County Med Complex	Milwaukee	Wisconsin
United States	Univ of Minnesota	Minneapolis	Minnesota
United States	Tulane Univ School of Medicine	New Orleans	Louisiana
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	Thomas Jefferson Med College	Philadelphia	Pennsylvania
United States	Maricopa County Med Ctr	Phoenix	Arizona
United States	AIDS Community Research Consortium	Redwood City	California
United States	Univ of Nevada / Veterans Administration Med Ctr	Reno	Nevada
United States	Community Health Network	Rochester	New York
United States	HIV Research Group	San Diego	California
United States	Dr Larry A Waites	San Francisco	California
United States	Dr Marcus Conant	San Francisco	California
United States	Saint Francis Mem Hosp / HIV Care	San Francisco	California
United States	San Francisco Veterans Administration Med Ctr	San Francisco	California
United States	Dr Marshall Kubota	Santa Rosa	California
United States	Dr Donald Romig	Sante Fe	New Mexico
United States	St Paul Ramsey Med Ctr	St Paul	Minnesota
United States	Dr Jeffrey Galpin	Tarzana	California

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacia

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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)

Moore RD, Chaisson RE. Survival analysis of two controlled trials of rifabutin prophylaxis against Mycobacterium avium complex in AIDS. AIDS. 1995 Dec;9(12):1337-42. — View Citation