Clinical trial NCT00002267: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mycobacterium Avium-intracellulare Infection
HIV Infections
Keywords: Rifabutin
AIDS-Related Opportunistic Infections
Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome
Antitubercular Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa County Med Ctr
state: Arizona
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
city: Beverly Hills
country: United States
facility: Pacific Oaks Med Group
state: California
city: Redwood City
country: United States
facility: AIDS Community Research Consortium
state: California
city: San Diego
country: United States
facility: HIV Research Group
state: California
city: San Francisco
country: United States
facility: Dr Larry A Waites
state: California
city: San Francisco
country: United States
facility: Saint Francis Mem Hosp / HIV Care
state: California
city: San Francisco
country: United States
facility: Dr Marcus Conant
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Administration Med Ctr
state: California
city: Santa Rosa
country: United States
facility: Dr Marshall Kubota
state: California
city: Tarzana
country: United States
facility: Dr Jeffrey Galpin
state: California
city: Miami
country: United States
facility: Miami Veterans Administration Med Ctr
state: Florida
city: Miami
country: United States
facility: Community Research Initiative of South Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Chicago
country: United States
facility: AIDS Research Alliance - Chicago
state: Illinois
city: New Orleans
country: United States
facility: Tulane Univ School of Medicine
state: Louisiana
city: Detroit
country: United States
facility: Comprehensive AIDS Alliance of Detroit / Harper Hosp
state: Michigan
city: Minneapolis
country: United States
facility: Univ of Minnesota
state: Minnesota
city: St Paul
country: United States
facility: St Paul Ramsey Med Ctr
state: Minnesota
city: Reno
country: United States
facility: Univ of Nevada / Veterans Administration Med Ctr
state: Nevada
city: Newark
country: United States
facility: North Jersey Community Research Initiative
state: New Jersey
city: Albuquerque
country: United States
facility: Univ of New Mexico Hlth Sciences Ctr / Dept of Med
state: New Mexico
city: Sante Fe
country: United States
facility: Dr Donald Romig
state: New Mexico
city: Albany
country: United States
facility: Albany Veterans Administration
state: New York
city: Buffalo
country: United States
facility: AIDS Services Erie County Med Ctr
state: New York
city: Rochester
country: United States
facility: Community Health Network
state: New York
city: Philadelphia
country: United States
facility: Buckley Braffman Stern Med Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson Med College
state: Pennsylvania
city: Columbia
country: United States
facility: Dr Alfred F Burnside Jr
state: South Carolina
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
city: Milwaukee
country: United States
facility: Milwaukee County Med Complex
state: Wisconsin
city: Calgary
country: Canada
facility: Univ of Calgary Health Science Ctr
state: Alberta
city: Edmonton
country: Canada
facility: Univ of Alberta/Division of Inf Dis/Dept of Med
state: Alberta
city: Vancouver
country: Canada
facility: Saint Paul's Hosp
state: British Columbia
city: Halifax
country: Canada
facility: Victoria Gen Hosp
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster Univ Med Ctr
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Gen Hosp
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hosp
state: Ontario
city: Toronto
country: Canada
facility: Saint Michael's Hosp
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Science Ctr
state: Ontario
city: Montreal
country: Canada
facility: Dr Emil Toma / Hotel Dieu de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Montreal Chest Institute
state: Quebec
city: Montreal
country: Canada
facility: Montreal Gen Hosp
state: Quebec
Study officials:
References:
citation: Dautzenberg B, Castellani P, Pellegrin JL, Vittecoq D, Truffot-Pernot C, Pirotta N, Sassella D. Early bactericidal activity of rifabutin versus that of placebo in treatment of disseminated Mycobacterium avium complex bacteremia in AIDS patients. Antimicrob Agents Chemother. 1996 Jul;40(7):1722-5. doi: 10.1128/AAC.40.7.1722.
citation: 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. doi: 10.1097/00002030-199512000-00006.