Trial Outcomes & Findings for Study of Daily Rifapentine for Pulmonary Tuberculosis (NCT NCT00814671)

NCT ID: NCT00814671

Last Updated: 2018-02-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 153 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2018-02-06

Participant Flow

192 individuals assessed for eligibility, 39 excluded, 153 randomized.

Participant milestones

Measure	RPT450 Rifapentine 450mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RIF 600 Rifampin 600mg daily Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RPT 600 Rifapentine 600mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Overall Study STARTED	54	48	51
Overall Study COMPLETED	47	44	49
Overall Study NOT COMPLETED	7	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Daily Rifapentine for Pulmonary Tuberculosis

Baseline characteristics by cohort

Measure	RPT450 n=54 Participants Rifapentine 450mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RIF 600 n=48 Participants Rifampin 600mg daily Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RPT 600 n=51 Participants Rifapentine 600mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	Total n=153 Participants Total of all reporting groups
Age, Continuous	29 years n=93 Participants	30 years n=4 Participants	29 years n=27 Participants	29 years n=483 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	13 Participants n=4 Participants	11 Participants n=27 Participants	37 Participants n=483 Participants
Sex: Female, Male Male	41 Participants n=93 Participants	35 Participants n=4 Participants	40 Participants n=27 Participants	116 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	54 Participants n=93 Participants	48 Participants n=4 Participants	51 Participants n=27 Participants	153 Participants n=483 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment South Africa	54 participants n=93 Participants	48 participants n=4 Participants	51 participants n=27 Participants	153 participants n=483 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: per protocol

Outcome measures

Measure	RPT450 n=41 Participants Rifapentine 450mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RIF 600 n=36 Participants Rifampin 600mg daily Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RPT 600 n=45 Participants Rifapentine 600mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Percentage of Participants With Negative Lowenstein Jensen Cultures at Week 8	85 percentage of participants w/LJ cx con	94 percentage of participants w/LJ cx con	96 percentage of participants w/LJ cx con

PRIMARY outcome

Timeframe: 10 weeks

Population: safety analysis population

percentage of participants discontinuing assigned treatment

Outcome measures

Measure	RPT450 n=54 Participants Rifapentine 450mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RIF 600 n=48 Participants Rifampin 600mg daily Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RPT 600 n=51 Participants Rifapentine 600mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Tolerability	2.0 percentage of participants	8.3 percentage of participants	2.0 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Data was not collected on some participants due to loss to follow up

Time to stable culture conversion (in days) on Lowenstein Jensen solid medium

Outcome measures

Measure	RPT450 n=41 Participants Rifapentine 450mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RIF 600 n=36 Participants Rifampin 600mg daily Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RPT 600 n=45 Participants Rifapentine 600mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Time to Stable Culture Conversion on Solid Medium	37 days Interval 29.0 to 57.0	43 days Interval 29.0 to 52.0	36 days Interval 29.0 to 50.0

SECONDARY outcome

Timeframe: 12 weeks

Time (in days) to stable culture conversion on liquid MGIT media

Outcome measures

Measure	RPT450 n=31 Participants Rifapentine 450mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RIF 600 n=46 Participants Rifampin 600mg daily Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RPT 600 n=45 Participants Rifapentine 600mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Time to Stable Culture Conversion on Liquid MGIT Media	50 days Interval 38.0 to 61.0	59 days Interval 36.0 to 63.0	57 days Interval 43.0 to 62.0

SECONDARY outcome

Timeframe: 8 weeks

area under the concentration time curve (AUC[0-24]) for rifapentine administered once daily at doses of 450 mg or 600 mg in the context of multi drug intensive phase TB treatment

Outcome measures

Measure	RPT450 n=36 Participants Rifapentine 450mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RIF 600 n=45 Participants Rifampin 600mg daily Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RPT 600 Rifapentine 600mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Pharmacokinetics of Rifapentine	330 ug x h/ml Interval 271.0 to 396.0	435 ug x h/ml Interval 294.0 to 504.0	—

Adverse Events

RPT450

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RIF 600

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

RPT 600

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	RPT450 n=54 participants at risk Rifapentine 450mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RIF 600 n=48 participants at risk Rifampin 600mg daily Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RPT 600 n=51 participants at risk Rifapentine 600mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Infections and infestations hospitalization	0.00% 0/54	2.1% 1/48	0.00% 0/51
Psychiatric disorders hospitalization for psychosis	0.00% 0/54	2.1% 1/48	0.00% 0/51

Other adverse events

Measure	RPT450 n=54 participants at risk Rifapentine 450mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RIF 600 n=48 participants at risk Rifampin 600mg daily Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks	RPT 600 n=51 participants at risk Rifapentine 600mg daily Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks
Hepatobiliary disorders hepatotoxicity	0.00% 0/54	4.2% 2/48	2.0% 1/51

Additional Information

Susan Dorman

Johns Hopkins University

Phone: 410-955-1755

Email: dsusan1@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place