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NCT00023348 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00023348
Other study ID # CDC-NCHSTP-2173
Secondary ID 23A
Status Completed
Phase Phase 2/Phase 3
First received September 6, 2001
Last updated September 9, 2005
Start date July 1999
Est. completion date November 2002

Study information
Verified date September 2005
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Primary Objectives:

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

Secondary Objectives:

1. To determine risk factors for abnormal pharmacokinetic parameters for 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date November 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion:

1. Patient enrolled in TBTC Study 23

2. Informed consent

Exclusion:

1. Severe anemia (Hct <25%)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Isoniazid

• Rifabutin

Locations
Country Name City State
Canada Montreal Chest Institute McGill University Montreal Quebec
Canada University of British Columbia Vancouver British Columbia
Canada University of Manitoba Winnipeg Manitoba
United States Johns Hopkins University School of Medicine Baltimore Maryland
United States Boston Medical Center Boston Massachusetts
United States Carolinas Medical Center Charlotte North Carolina
United States Chicago VA Medical Center (Lakeside) Chicago Illinois
United States Denver Department of Public Health and Hospitals Denver Colorado
United States Duke University Medical Center Durham North Carolina
United States University of North Texas Health Science Center Fort Worth Texas
United States Hines VA Medical Center Hines Illinois
United States Thomas Street Clinic Houston Texas
United States Central Arkansas Veterans Health System Little Rock Arkansas
United States LA County/USC Medical Center Los Angeles California
United States Nashville VA Medical Center Nashville Tennessee
United States Columbia University/Presbyterian Medical Center New York New York
United States Harlem Hospital Center New York New York
United States New York University School of Medicine New York New York
United States New Jersey Medical School Newark New Jersey
United States Audi L. Murphy VA Hospital San Antonio Texas
United States University of California, San Francisco San Francisco California
United States Seattle King County Health Department Seattle Washington
United States Washington, D.C. VAMC Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
Centers for Disease Control and Prevention VA Office of Research and Development

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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 wit — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetics of isoniazid and rifabutin.
Secondary 1) To determine risk factors for abnormal pharmacokinetics of isoniazid and rifabutin
Secondary 2) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
Secondary 3) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
Secondary 4) To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.
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