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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00002032

Recruitment Status : Completed

First Posted : August 31, 2001

Last Update Posted : June 24, 2005

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mycobacterium Avium-intracellulare Infection HIV Infections	Drug: Rifabutin	Not Applicable

Study Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	750 participants
Masking:	Double
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 the National Library of Medicine

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

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted:	August 31, 2001 Key Record Dates
Last Update Posted:	June 24, 2005
Last Verified:	January 1992

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 Communicable Diseases HIV Infections Bacteremia Mycobacterium Infections Mycobacterium avium-intracellulare Infection Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases	Bacterial Infections Sepsis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Actinomycetales Infections Gram-Positive Bacterial Infections Mycobacterium Infections, Nontuberculous Rifabutin Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antitubercular Antitubercular Agents

To Top