TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB - 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:	NCT00023348

Purpose

Primary Objectives:

1) To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin.

Secondary Objectives:

To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin.
To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.

Condition	Intervention	Phase
HIV Infections Tuberculosis	Drug: Isoniazid Drug: Rifabutin	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Pharmacokinetics Study
Official Title:	TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in USPHS 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: Isoniazid Rifabutin Ftivazide

U.S. FDA Resources

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

Primary Outcome Measures:

To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetics of isoniazid and rifabutin.

Secondary Outcome Measures:

1) To determine risk factors for abnormal pharmacokinetics of isoniazid and rifabutin
2) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
3) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
4) To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.

Estimated Enrollment:	150
Study Start Date:	July 1999
Estimated Study Completion Date:	November 2002

Detailed Description:

This study will seek to enroll every eligible patient enrolled in TBTC Study 23. Consenting patients will be asked to undergo measurements of isoniazid (if receiving), rifabutin and 25-OH desacetyl rifabutin levels at a time point in the study when steady state rifabutin levels are expected to have been achieved (at least two weeks following the start of rifabutin).

Eligibility

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

Criteria

Inclusion:

Patient enrolled in TBTC Study 23
Informed consent

Exclusion:

1. Severe anemia (Hct <25%)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023348

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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

Principal Investigator:

Marc Weiner, MD

Audie L. Murphy VA Medical Center, San Antonio TX

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-2173, 23A
Study First Received:	September 6, 2001
Last Updated:	September 9, 2005
ClinicalTrials.gov Identifier:	NCT00023348 History of Changes
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:

Tuberculosis
TB

Additional relevant MeSH terms:

Bacterial Infections
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Rifabutin
Molecular Mechanisms of Pharmacological Action
Infection
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Therapeutic Uses
Tuberculosis
Retroviridae Infections
Isoniazid
RNA Virus Infections

Immune System Diseases
Antilipemic Agents
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Actinomycetales Infections
Pharmacologic Actions
Antibiotics, Antitubercular
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Mycobacterium Infections
Antitubercular Agents
Fatty Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009