TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis

Centers for Disease Control and Prevention (CDC)

Status and phase: Completed; Phase 2

Conditions: Tuberculosis

Treatments: Drug: rifapentine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00023426

HCK45

25

CDC-NCHSTP-2404

Details and patient eligibility

About

Randomized, double-blind study of the tolerability of three different doses of rifapentine

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind