Pulmonary Tuberculosis Clinical Trial
Official title:
TBTC Study 22: Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Twice-Weekly Rifampin and Isoniazid in the Continuation Phase of Therapy for Pulmonary Tuberculosis
Primary Objective: To compare, at the completion of the follow-up phase, the clinical and
bacteriologic relapse rates associated with the two study regimens.
Secondary Objectives:
To compare the clinical and bacteriologic failure rates of the two study regimens at the
completion of the study phase therapy.
To compare the clinical and bacteriologic response rates for the two study regimens among
patients who began study phase therapy with signs and symptoms of tuberculosis or cultures
positive for M. tuberculosis.
To compare the toxicity associated with the two study regimens by comparing discontinuation
rates due to adverse events and occurrence rates of signs and symptoms associated with
adverse events during study phase therapy.
To compare mortality rates of the two study regimens. To compare the rates of completion of
therapy within 22 weeks for the two study regimens.
To compare the rate of development of drug-resistant tuberculosis in the two study regimens
among study patients classified as treatment failures or relapses.
To compare all of the above performance characteristics for the two study regimens in a
small subset of HIV seropositive patients.
To compare attitudes and beliefs about participation in this study between patients who
complete study therapy and those who fail to complete study therapy.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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