Clinical trial NCT00002032: 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 objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in these patients. A secondary objective is to compare clinical response, quality of life (Karnofsky), and survival between these two groups.


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.
* Females of childbearing potential must also sign a special informed consent.

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: Irvine
country: United States
facility: Ctr for Special Immunology
state: California
city: Sylmar
country: United States
facility: Olive View Med Ctr
state: California
city: Denver
country: United States
facility: Denver Public Health Dept
state: Colorado
city: Washington
country: United States
facility: Veterans Administration Med Ctr
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Ctr for Special Immunology
state: Florida
city: Fort Lauderdale
country: United States
facility: TheraFirst Med Ctrs Inc
state: Florida
city: Hollywood
country: United States
facility: Mem Hosp Hollywood
state: Florida
city: Orlando
country: United States
facility: VP Med Services / HHCS Research Institute Inc
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Grady Memorial Hosp / Hughs Spalding Med Ctr
state: Georgia
city: Roswell
country: United States
facility: Dr Winkler Weinberg
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Brookline
country: United States
facility: CRI of New England
state: Massachusetts
city: Kansas City
country: United States
facility: Univ of Missouri at Kansas City School of Medicine
state: Missouri
city: Kansas City
country: United States
facility: Research Med Ctr
state: Missouri
city: Brooklyn
country: United States
facility: Brooklyn Veterans Administration
state: New York
city: Brooklyn
country: United States
facility: Maimonides Med Ctr
state: New York
city: East Meadow
country: United States
facility: Nassau County Med Ctr
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Med Ctr
state: New York
city: New York
country: United States
facility: Community Research Initiative
state: New York
city: New York
country: United States
facility: Chelsea Village Med Ctr
state: New York
city: New York
country: United States
facility: Mem Sloan - Kettering Cancer Ctr
state: New York
city: Cleveland
country: United States
facility: Univ Hosp of Cleveland / Case Western Reserve Univ
state: Ohio
city: Columbus
country: United States
facility: Ohio State Univ Med Ctr
state: Ohio
city: Austin
country: United States
facility: Central Texas Med Foundation
state: Texas
city: Dallas
country: United States
facility: Nelson Tebedo Community Clinic
state: Texas
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: El Paso
country: United States
facility: Texas Tech Health Sciences Ctr
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Network
state: Texas
city: San Antonio
country: United States
facility: Univ TX San Antonio Health Science Ctr
state: Texas
city: Temple
country: United States
facility: Scott and White Hosp
state: Texas
city: Waco
country: United States
facility: Dr Scott Lea
state: Texas
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.