TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis
|ClinicalTrials.gov Identifier: NCT00023335|
Recruitment Status : Completed
First Posted : September 10, 2001
Last Update Posted : September 5, 2005
Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens.
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Tuberculosis||Drug: Rifapentine Drug: Isoniazid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 1995|
|Study Completion Date :||March 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023335
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