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: NCT00002032
• Other study ID #: 048A
• Secondary ID: 087023-999
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: January 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 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.

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.

• 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.

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