TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00023400

Collaborator

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

Enrollment

Locations

Duration (Months)

0.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

To define the impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on peak levels and area under the curve for rifabutin and the rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as part of tuberculosis chemotherapy.

Secondary Objectives:

To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin.

To evaluate the correlation between pharmacokinetic parameters of rifabutin and 25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients with HIV-related tuberculosis.

To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with HIV-related tuberculosis.

To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic studies.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Tuberculosis	Drug: Nelfinavir Drug: Rifabutin	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

TBTC Study 23B:Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen

Study Start Date :

Feb 1, 2000

Study Completion Date :

Feb 1, 2002

Outcome Measures

Primary Outcome Measures

Impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on area under the curve for rifabutin and 25-O-desacetyl rifabutin when rifabutin is given 300 mg bi-weekly as part of tuberculosis chemotherapy. []

Secondary Outcome Measures

To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Patients with HIV-related tuberculosis

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