A Phase 3 interventional study of Rifapentine and Isoniazid in Pulmonary Tuberculosis, sponsored by Centers for Disease Control and Prevention. Completed at 23 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-09-05.
Sponsored by Centers for Disease Control and Prevention · Phase 3, Interventional, and Treatment
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 1,000 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
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This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.
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Centers for Disease Control and Prevention