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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR RIFAPENTINE

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Clinical Trials for Rifapentine

Trial ID Title Status Sponsor Phase Summary
NCT00002192 Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia. Completed Hoechst Marion Roussel Phase 2 To determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.
NCT00002192 Tolerance, Safety, and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia. Completed Anderson Clinical Research Phase 2 To determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex (MAC) bacteremia. To determine the pharmacokinetics of rifapentine and its metabolite, 25-desacetyl, alone and in combination therapy. To determine the pharmacokinetics of azithromycin and clarithromycin (and its 14-OH metabolite) in combination therapy.
NCT00023335 TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis Completed VA Office of Research and Development Phase 3 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.
NCT00023335 TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis Completed Centers for Disease Control and Prevention Phase 3 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.
NCT00023387 TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine Completed VA Office of Research and Development N/A Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg. Secondary objective: To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.
NCT00023387 TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine Completed Centers for Disease Control and Prevention N/A Primary objective: To compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg. Secondary objective: To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.
NCT00023426 TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis Completed VA Office of Research and Development Phase 2 Randomized, double-blind study of the tolerability of three different doses of rifapentine
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Rifapentine

Condition Name

Condition Name for Rifapentine
Intervention Trials
Tuberculosis 21
HIV Infections 3
Latent Tuberculosis 2
Pulmonary Tuberculosis 2
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Condition MeSH

Condition MeSH for Rifapentine
Intervention Trials
Tuberculosis 31
Latent Tuberculosis 7
Tuberculosis, Pulmonary 7
Infection 4
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Clinical Trial Locations for Rifapentine

Trials by Country

Trials by Country for Rifapentine
Location Trials
United States 121
Canada 18
South Africa 15
Brazil 13
Kenya 6
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Trials by US State

Trials by US State for Rifapentine
Location Trials
New York 12
Maryland 11
Texas 11
California 10
North Carolina 9
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Clinical Trial Progress for Rifapentine

Clinical Trial Phase

Clinical Trial Phase for Rifapentine
Clinical Trial Phase Trials
Phase 4 6
Phase 3 12
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Rifapentine
Clinical Trial Phase Trials
Completed 19
Not yet recruiting 9
Recruiting 7
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Clinical Trial Sponsors for Rifapentine

Sponsor Name

Sponsor Name for Rifapentine
Sponsor Trials
Centers for Disease Control and Prevention 14
VA Office of Research and Development 6
Johns Hopkins University 6
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Sponsor Type

Sponsor Type for Rifapentine
Sponsor Trials
Other 49
U.S. Fed 21
Industry 8
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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Citi
Medtronic
Fish and Richardson
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Farmers Insurance
Johnson and Johnson
Cipla
Express Scripts

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