HIV Infections Clinical Trial
Official title:
TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
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).
Status | Completed |
Enrollment | 215 |
Est. completion date | February 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Chest Institute McGill University | Montreal | Quebec |
Canada | University of British Columbia | Vancouver | British Columbia |
Canada | University of Manitoba | Winnipeg | Manitoba |
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | Chicago VA Medical Center (Lakeside) | Chicago | Illinois |
United States | Denver Department of Public Health and Hospitals | Denver | Colorado |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of North Texas Health Science Center | Fort Worth | Texas |
United States | Hines VA Medical Center | Hines | Illinois |
United States | Thomas Street Clinic | Houston | Texas |
United States | Central Arkansas Veterans Health System | Little Rock | Arkansas |
United States | LA County/USC Medical Center | Los Angeles | California |
United States | Nashville VA Medical Center | Nashville | Tennessee |
United States | Columbia University/Presbyterian Medical Center | New York | New York |
United States | Harlem Hospital Center | New York | New York |
United States | New York University School of Medicine | New York | New York |
United States | New Jersey Medical School | Newark | New Jersey |
United States | Audi L. Murphy VA Hospital | San Antonio | Texas |
United States | University of California, San Francisco | San Francisco | California |
United States | Seattle King County Health Department | Seattle | Washington |
United States | Washington, D.C. VAMC | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention | VA Office of Research and Development |
United States, Canada,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of confirmed treatment failure and relapse | |||
Secondary | Safety and tolerability | |||
Secondary | Response of HIV RNA to TB treatment | |||
Secondary | Paradoxical reactions |
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