A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS - Full Text View

Purpose

To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.

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

MedlinePlus related topics:

AIDS

Drug Information available for:

Rifabutin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Safety Study

Official Title:	A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

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

Estimated Enrollment:

200

Eligibility

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

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

Zidovudine (AZT).
Didanosine (ddI).

Patients must have the following:

Diagnosis of AIDS as defined by the CDC.
Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).
Provide written informed consent.

Prior Medication:

Allowed:

If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.
Required:
Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Known hypersensitivity to any of the study drugs.

Concurrent Medication:

Excluded:

Other therapy for mycobacterial disease.

Patients with the following are excluded:

Known hypersensitivity to any of the study drugs.

Prior Medication:

Excluded within 4 weeks:

Therapy for mycobacterial disease.
Antiretroviral drugs, other than zidovudine (AZT) or ddI.
Investigational drugs, other than ddI.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001995

Locations


United States, Arizona
	Maricopa County Med Ctr
	Phoenix, Arizona, United States, 85010

United States, California
	San Francisco Veterans Administration Med Ctr
	San Francisco, California, United States, 94121
	Ctr for Special Immunology
	Irvine, California, United States, 92718
	AIDS Community Research Consortium
	Redwood City, California, United States, 94063
	Southwest Community Based AIDS Treatment Group - COMBAT
	Los Angeles, California, United States, 90028
	HIV Research Group
	San Diego, California, United States, 92102
	Bay Harbor Hosp
	Harbor City, California, United States, 90710
	Davies Med Ctr
	San Francisco, California, United States, 94114

United States, District of Columbia
	Veterans Administration Med Ctr
	Washington, District of Columbia, United States, 20422

United States, Florida
	Miami Veterans Administration Med Ctr
	Miami, Florida, United States, 33125
	Mem Hosp Hollywood
	Hollywood, Florida, United States, 33021
	Ctr for Special Immunology
	Fort Lauderdale, Florida, United States, 33316
	TheraFirst Med Ctrs Inc
	Fort Lauderdale, Florida, United States, 33308

United States, Georgia
	Infectious Disease Research Consortium of Georgia
	Atlanta, Georgia, United States, 30076

United States, Minnesota
	Dr Frank Rhame
	Minneapolis, Minnesota, United States, 55455

United States, Missouri
	Research Med Ctr
	Kansas City, Missouri, United States, 64132

United States, New Jersey
	North Jersey Community Research Initiative
	Newark, New Jersey, United States, 071032842

United States, New York
	Chelsea Village Med Ctr / Saint Vincent's Hosp
	New York, New York, United States, 10014
	Nassau County Med Ctr
	East Meadow, New York, United States, 11554

United States, South Carolina
	Dr Alfred F Burnside Jr
	Columbia, South Carolina, United States, 29204

United States, Virginia
	Infectious Disease Physicians Inc
	Annandale, Virginia, United States, 22203

United States, Wisconsin
	Milwaukee County Med Complex
	Milwaukee, Wisconsin, United States, 53226

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)

Study ID Numbers:	048C, CS 087065
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00001995
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Rifabutin

Mycobacterium avium-intracellulare Infection

Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:

Bacterial Infections

Systemic Inflammatory Response Syndrome

Sexually Transmitted Diseases, Viral

Rifabutin

Acquired Immunodeficiency Syndrome

Bacteremia

Mycobacterium Infections, Atypical

Immunologic Deficiency Syndromes

Inflammation

Mycobacterium avium-intracellulare Infection

Virus Diseases

Gram-Positive Bacterial Infections

Sepsis

HIV Infections

Sexually Transmitted Diseases

Mycobacterium Infections

Mycobacterium avium complex infection

Retroviridae Infections

Additional relevant MeSH terms:

Communicable Diseases

Anti-Infective Agents

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Infection

Actinomycetales Infections

Pharmacologic Actions

Antibiotics, Antitubercular

Anti-Bacterial Agents

Pathologic Processes

Therapeutic Uses

Lentivirus Infections

Antitubercular Agents

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Pharmacia
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00001995