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 - Full Text View

Purpose

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.

Condition	Intervention
Mycobacterium Avium-intracellulare Infection HIV Infections	Drug: Rifabutin


Study Type:	Interventional
Study Design:	Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Mycobacterial Infections

Drug Information available for: Rifabutin

Genetic and Rare Diseases Information Center resources: Mycobacterium Avium Complex

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:


Estimated Enrollment:	750

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002032

Show 33 Study Locations

Sponsors and Collaborators

Pharmacia

More Information

Publications:

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.


ClinicalTrials.gov Identifier:	NCT00002032 History of Changes
Other Study ID Numbers:	048A, 087023-999
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:


Rifabutin AIDS-Related Opportunistic Infections Mycobacterium avium-intracellulare Infection Acquired Immunodeficiency Syndrome Antitubercular Agents

Additional relevant MeSH terms:


Infection Mycobacterium Infections Mycobacterium avium-intracellulare Infection Actinomycetales Infections Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections, Nontuberculous	Rifabutin Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antitubercular Antitubercular Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015