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

Centers for Disease Control and Prevention (CDC)

Status

Completed

Conditions

Tuberculosis

HIV Infections

Treatments

Drug: Rifabutin

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00023361

CDC-NCHSTP-2174

TBTC STUDY 23

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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