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

Completed · Not applicable

Conditions studied: HIV Infections, Tuberculosis

In brief

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).

Key facts

Study ID

NCT00023361

Run by

Centers for Disease Control and Prevention

People needed

215

Starts

1999-02-01

Expected to finish

2003-02-01

Last updated by the study team

2005-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Central Arkansas Veterans Health System — Little Rock, Arkansas, United States
• LA County/USC Medical Center — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Denver Department of Public Health and Hospitals — Denver, Colorado, United States
• Washington, D.C. VAMC — Washington D.C., District of Columbia, United States
• Chicago VA Medical Center (Lakeside) — Chicago, Illinois, United States
• Hines VA Medical Center — Hines, Illinois, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• New Jersey Medical School — Newark, New Jersey, United States
• New York University School of Medicine — New York, New York, United States
• Columbia University/Presbyterian Medical Center — New York, New York, United States
• Harlem Hospital Center — New York, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Nashville VA Medical Center — Nashville, Tennessee, United States
• University of North Texas Health Science Center — Fort Worth, Texas, United States
• Thomas Street Clinic — Houston, Texas, United States
• Audi L. Murphy VA Hospital — San Antonio, Texas, United States
• Seattle King County Health Department — Seattle, Washington, United States
• University of British Columbia — Vancouver, British Columbia, Canada
• University of Manitoba — Winnipeg, Manitoba, Canada
• Montreal Chest Institute McGill University — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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