TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen

• Sponsor: Centers for Disease Control and Prevention (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00023361
• Collaborator: US Department of Veterans Affairs (U.S. Fed)
• Enrollment: 215
• Locations: 23
• Duration (Months): 48
• Patients Per Site: 9.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Primary objective:

To determine the rate of confirmed treatment failure and relapse with an intermittent rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible HIV-related tuberculosis (TB).

Condition or Disease	Intervention/Treatment	Phase
HIV Infections; Tuberculosis	Drug: Rifabutin	N/A

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
• Study Start Date: Feb 1, 1999
• Study Completion Date: Feb 1, 2003

Outcome Measures

Primary Outcome Measures

1. Rate of confirmed treatment failure and relapse []

Secondary Outcome Measures

1. Safety and tolerability []

2. Response of HIV RNA to TB treatment []

3. Paradoxical reactions []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

• Clinical diagnosis of pulmonary &/or extrapulmonary TB confirmed by a positive culture and susceptibility to rifampin. Patients having isoniazid or pyrazinamide (PZA)-resistant isolates are eligible to continue in the study on a modified regimen

• Evidence of HIV infection confirmed by a positive serologic test (ELISA and Western Blot).

• Absolute neutrophil count >500/mm3 (use of colony stimulating factors, filgrastim, or sargramostim is allowed)

• 18 years of age

• Willingness to practice effective contraception if applicable

• Signed informed consent

Exclusion Criteria

• Pregnancy or breastfeeding

• AST > 10 times the upper limit of normal

• Bilirubin > 3.0 times the upper limit of normal

• Creatinine > 3.0 times the upper limit of normal

• Intolerance to any of the study drugs except isoniazid or pyrazinamide

• Concomitant disorder that is contraindication to the use of the study drugs

• More than 28 days of treatment for active tuberculosis within the 6 months prior to this course of therapy

• Bone/joint tuberculosis or silicotuberculosis

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

Sponsors and Collaborators

• Centers for Disease Control and Prevention
• US Department of Veterans Affairs

Investigators

• Study Chair: William Burman, MD, Denver Health and Hospitals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• (Click here for more information about the Tuberculosis Trials Consortium(TBTC)

Publications

• Weiner M, Benator D, Burman W, Peloquin CA, Khan A, Vernon A, Jones B, Silva-Trigo C, Zhao Z, Hodge T; Tuberculosis Trials Consortium. Association between acquired rifamycin resistance and the pharmacokinetics of rifabutin and isoniazid among patients with HIV and tuberculosis. Clin Infect Dis. 2005 May 15;40(10):1481-91. Epub 2005 Apr 14.

• ClinicalTrials.gov Identifier: NCT00023361
• Other Study ID Numbers: CDC-NCHSTP-2174; TBTC STUDY 23
• First Posted: Sep 10, 2001
• Last Update Posted: Sep 5, 2005
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: tuberculosis; TB
• Additional relevant MeSH terms: Tuberculosis; Rifabutin

Study Results

No Results Posted as of Sep 5, 2005