TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen - Full Text View

Sponsor:	Centers for Disease Control and Prevention
Collaborator:	Department of Veterans Affairs
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00023361

Purpose

Primary objective:

To determine the rate of confirmed treatment failure and relapse with an intermittent rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible HIV-related tuberculosis (TB).

Condition	Intervention
HIV Infections Tuberculosis	Drug: Rifabutin

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen

Resource links provided by NLM:

MedlinePlus related topics: AIDS Tuberculosis

Drug Information available for: Rifabutin

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

Rate of confirmed treatment failure and relapse

Secondary Outcome Measures:

Safety and tolerability
Response of HIV RNA to TB treatment
Paradoxical reactions

Estimated Enrollment:	215
Study Start Date:	February 1999
Estimated Study Completion Date:	February 2003

Eligibility

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

Criteria

Inclusion Criteria

Clinical diagnosis of pulmonary &/or extrapulmonary TB confirmed by a positive culture and susceptibility to rifampin. Patients having isoniazid or pyrazinamide (PZA)-resistant isolates are eligible to continue in the study on a modified regimen
Evidence of HIV infection confirmed by a positive serologic test (ELISA and Western Blot).
Absolute neutrophil count >500/mm3 (use of colony stimulating factors, filgrastim, or sargramostim is allowed)
> 18 years of age
Willingness to practice effective contraception if applicable
Signed informed consent

Exclusion Criteria

Pregnancy or breastfeeding
AST > 10 times the upper limit of normal
Bilirubin > 3.0 times the upper limit of normal
Creatinine > 3.0 times the upper limit of normal
Intolerance to any of the study drugs except isoniazid or pyrazinamide
Concomitant disorder that is contraindication to the use of the study drugs
More than 28 days of treatment for active tuberculosis within the 6 months prior to this course of therapy
Bone/joint tuberculosis or silicotuberculosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023361

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Locations

United States, Arkansas
Central Arkansas Veterans Health System
Little Rock, Arkansas, United States, 72205
United States, California
LA County/USC Medical Center
Los Angeles, California, United States, 90033
University of California, San Francisco
San Francisco, California, United States, 94110
United States, Colorado
Denver Department of Public Health and Hospitals
Denver, Colorado, United States, 80204
United States, District of Columbia
Washington, D.C. VAMC
Washington, District of Columbia, United States, 20422
United States, Illinois
Hines VA Medical Center
Hines, Illinois, United States, 60141
Chicago VA Medical Center (Lakeside)
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287-0003
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New Jersey
New Jersey Medical School
Newark, New Jersey, United States, 07107-3001
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Columbia University/Presbyterian Medical Center
New York, New York, United States, 10032
Harlem Hospital Center
New York, New York, United States, 10037
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 34222
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Tennessee
Nashville VA Medical Center
Nashville, Tennessee, United States, 37212-2637
United States, Texas
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76107-2699
Thomas Street Clinic
Houston, Texas, United States, 77009
Audi L. Murphy VA Hospital
San Antonio, Texas, United States, 78284
United States, Washington
Seattle King County Health Department
Seattle, Washington, United States, 98104
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, Canada V5Z 4R4
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, CANADA R3A 1R8
Canada, Quebec
Montreal Chest Institute McGill University
Montreal, Quebec, Canada, H2X 2P4Pq Canada

Sponsors and Collaborators

Centers for Disease Control and Prevention

Department of Veterans Affairs

Investigators

Study Chair:

William Burman, MD

Denver Health and Hospitals

More Information

Additional Information:

(Click here for more information about the Tuberculosis Trials Consortium(TBTC) This link exits the ClinicalTrials.gov site

Publications:

Weiner M, Benator D, Burman W, Peloquin CA, Khan A, Vernon A, Jones B, Silva-Trigo C, Zhao Z, Hodge T; Tuberculosis Trials Consortium. Association between acquired rifamycin resistance and the pharmacokinetics of rifabutin and isoniazid among patients with HIV and tuberculosis. Clin Infect Dis. 2005 May 15;40(10):1481-91. Epub 2005 Apr 14.

Study ID Numbers:	CDC-NCHSTP-2174, TBTC STUDY 23
Study First Received:	September 6, 2001
Last Updated:	September 1, 2005
ClinicalTrials.gov Identifier:	NCT00023361 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:

tuberculosis
TB

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Rifabutin
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Pharmacologic Actions
Actinomycetales Infections
Immunologic Deficiency Syndromes

Antibiotics, Antitubercular
Virus Diseases
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Mycobacterium Infections
Tuberculosis
Antitubercular Agents
Retroviridae Infections

ClinicalTrials.gov processed this record on November 25, 2009