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

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborators: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Rifabutin

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