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

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).

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