HIV Infections, Tuberculosis
Conditions
Keywords
tuberculosis, TB
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).
Interventions
DRUGRifabutin
Sponsors
US Department of Veterans Affairs
Centers for Disease Control and Prevention
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of confirmed treatment failure and relapse | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability | — |
| Response of HIV RNA to TB treatment | — |
| Paradoxical reactions | — |
Countries
Canada, United States
Outcome results
None listed