NCT00023426CompletedPhase 2
TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine
Centers for Disease Control and Prevention23 sites in 2 countries150 target enrollmentStarted: July 1, 1999Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 23
- Primary Endpoint
- Proportion of patients who fail to complete therapy in each of the dosing groups
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusions:
- •Drug susceptible culture-positive tuberculosis
- •Adequate induction therapy
- •Normal screening labs
- •Karnofsky >=60
- •Informed consent
- •Birth control if of child bearing potential
- •Exclusions:
- •Skeletal or CNS TB
- •Pregnant or breastfeeding
- •Intolerance to INH or rifamycins
- •Over 70 days TB treatment just prior to enrollment
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Proportion of patients who fail to complete therapy in each of the dosing groups
Secondary Outcomes
- 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
Investigators
Study Sites (23)
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