TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00023426

Collaborator

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

150

Enrollment

Locations

43.1

Duration (Months)

6.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Randomized, double-blind study of the tolerability of three different doses of rifapentine

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis	Drug: rifapentine	Phase 2

Detailed Description

Prospective, randomized, double-blinded, comparative study. Patients are randomized at the completion of induction phase therapy. Sample-size is 50 HIV-seronegative patients with culture-positive, drug susceptible TB in each treatment arm. The first 75 patients will be randomized 2:1 to 900 mg:600 mg rifapentine. The second 75 patients will be randomized 2:1 to 1200 mg:600 mg rifapentine. The DSMB will review tolerability and safety data on the first 21 patients enrolled (at the 900 mg and 600 mg doses) and approve proceeding to enrollment at the 1200 mg dose.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine

Study Start Date :

Jul 1, 1999

Study Completion Date :

Feb 1, 2003

Outcome Measures

Primary Outcome Measures

Proportion of patients who fail to complete therapy in each of the dosing groups []

Secondary Outcome Measures

1. Rate of serious adverse events in each of the dosing groups []
2. Rate of total adverse events in each of the groups []
3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusions:

Drug susceptible culture-positive tuberculosis
Adequate induction therapy
Age >18
Normal screening labs
Karnofsky >=60
Informed consent
Birth control if of child bearing potential

Exclusions:

SilicoTB
Skeletal or CNS TB
Pregnant or breastfeeding
Intolerance to INH or rifamycins
Over 70 days TB treatment just prior to enrollment

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