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

Sponsor

Centers for Disease Control and Prevention (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00023348

Collaborator

US Department of Veterans Affairs (U.S. Fed)

150

Enrollment

Locations

Duration (Months)

6.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objectives:

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 or Disease	Intervention/Treatment	Phase
HIV Infections Tuberculosis	Drug: Isoniazid Drug: Rifabutin	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 1999

Study Completion Date :

Nov 1, 2002

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion:

Patient enrolled in TBTC Study 23
Informed consent

Exclusion:

Severe anemia (Hct <25%)

Contacts and Locations

Locations

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