Tuberculosis
Conditions
Keywords
tuberculosis, tb, rifapentine, safety, dose
Brief summary
Randomized, double-blind study of the tolerability of three different doses of rifapentine
Detailed description
Prospective, randomized, double-blinded, comparative study. Patients are randomized at the completion of induction phase therapy. Sample-size is 50 HIV-seronegative patients with culture-positive, drug susceptible TB in each treatment arm. The first 75 patients will be randomized 2:1 to 900 mg:600 mg rifapentine. The second 75 patients will be randomized 2:1 to 1200 mg:600 mg rifapentine. The DSMB will review tolerability and safety data on the first 21 patients enrolled (at the 900 mg and 600 mg doses) and approve proceeding to enrollment at the 1200 mg dose.
Interventions
DRUGrifapentine
Sponsors
US Department of Veterans Affairs
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusions: 1. Drug susceptible culture-positive tuberculosis 2. Adequate induction therapy 3. Age \>18 4. Normal screening labs 5. Karnofsky \>=60 6. Informed consent 7. Birth control if of child bearing potential Exclusions: 1. SilicoTB 2. Skeletal or CNS TB 3. Pregnant or breastfeeding 4. Intolerance to INH or rifamycins 5. Over 70 days TB treatment just prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who fail to complete therapy in each of the dosing groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of serious adverse events in each of the dosing groups | — |
| 2. Rate of total adverse events in each of the groups | — |
| 3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups | — |
Countries
Canada, United States
Outcome results
None listed