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

Phase 2

Completed

• Conditions: HIV Infections; Tuberculosis

• Registration Number: NCT00023348
• Lead Sponsor: Centers for Disease Control and Prevention

Brief 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.

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).

Study Timeline

• Study Start: 1999-07
• Study First Submitted: 2001-09-06
• Study First Submitted QC: 2001-09-08
• Study First Posted: 2001-09-10
• Study Completion: 2002-11
• Status Verified: 2005-09
• Last Update Submitted: 2005-09-09
• Last Update Posted: 2005-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (23)

Central Arkansas Veterans Health System; 🇺🇸 Little Rock, Arkansas, United States

LA County/USC Medical Center; 🇺🇸 Los Angeles, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Denver Department of Public Health and Hospitals; 🇺🇸 Denver, Colorado, United States

Washington, D.C. VAMC; 🇺🇸 Washington, District of Columbia, United States

Chicago VA Medical Center (Lakeside); 🇺🇸 Chicago, Illinois, United States

Hines VA Medical Center; 🇺🇸 Hines, Illinois, United States

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

New Jersey Medical School; 🇺🇸 Newark, New Jersey, United States

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