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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Rifabutin

U.S. FDA Resources

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
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00001995 History of Changes
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

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Rifabutin
Infection
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Pathologic Processes
Therapeutic Uses
Retroviridae Infections
Systemic Inflammatory Response Syndrome
RNA Virus Infections
Immune System Diseases

Acquired Immunodeficiency Syndrome
Bacteremia
Pharmacologic Actions
Immunologic Deficiency Syndromes
Actinomycetales Infections
Mycobacterium Infections, Atypical
Antibiotics, Antitubercular
Mycobacterium avium-intracellulare Infection
Inflammation
Virus Diseases
Sepsis
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on November 27, 2009