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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in USPHS Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen

Conditions
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HIV Infections, Tuberculosis

Intervention / Treatment
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* Drug: Isoniazid
* Drug: Rifabutin


Participation Criteria
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Eligibility Criteria
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Inclusion: Patient enrolled in TBTC Study 23 Informed consent Exclusion: 1. Severe anemia (Hct <25%)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Isoniazid|nan|
|Drug: Rifabutin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetics of isoniazid and rifabutin. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tuberculosis, TB