Clinical trial NCT00023361: TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
Official title: TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Tuberculosis
Keywords: tuberculosis
TB
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2001-09-10
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Rate of confirmed treatment failure and relapse
Secondary outcomes:
measure: Safety and tolerability
measure: Response of HIV RNA to TB treatment
measure: Paradoxical reactions
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas Veterans Health System
state: Arkansas
city: Los Angeles
country: United States
facility: LA County/USC Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: Denver Department of Public Health and Hospitals
state: Colorado
city: Washington
country: United States
facility: Washington, D.C. VAMC
state: District of Columbia
city: Chicago
country: United States
facility: Chicago VA Medical Center (Lakeside)
state: Illinois
city: Hines
country: United States
facility: Hines VA Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Newark
country: United States
facility: New Jersey Medical School
state: New Jersey
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University/Presbyterian Medical Center
state: New York
city: New York
country: United States
facility: Harlem Hospital Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Nashville VA Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
city: Houston
country: United States
facility: Thomas Street Clinic
state: Texas
city: San Antonio
country: United States
facility: Audi L. Murphy VA Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle King County Health Department
state: Washington
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Montreal
country: Canada
facility: Montreal Chest Institute McGill University
state: Quebec
Study officials:
affiliation: Denver Health and Hospitals
name: William Burman, MD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1086/429321. Epub 2005 Apr 14.