TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis
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Randomized, double-blind study of the tolerability of three different doses of rifapentine
Condition or disease
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Drug susceptible culture-positive tuberculosis
Adequate induction therapy
Normal screening labs
Birth control if of child bearing potential
Skeletal or CNS TB
Pregnant or breastfeeding
Intolerance to INH or rifamycins
Over 70 days TB treatment just prior to enrollment