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Study of Daily Rifapentine for Pulmonary Tuberculosis

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ClinicalTrials.gov Identifier: NCT00814671
Recruitment Status : Completed
First Posted : December 25, 2008
Results First Posted : September 28, 2016
Last Update Posted : February 6, 2018
Sponsor:
Collaborators:
University of Cape Town Lung Institute
University of Cape Town
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tuberculosis
Interventions Drug: Rifapentine 450
Drug: Rifapentine 600
Drug: Rifampin
Enrollment 153
Recruitment Details 192 individuals assessed for eligibility, 39 excluded, 153 randomized.
Pre-assignment Details  
Arm/Group Title RPT450 RIF 600 RPT 600
Hide Arm/Group Description

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

Rifampin 600mg daily

Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks

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

Period Title: Overall Study
Started 54 48 51
Completed 47 44 49
Not Completed 7 4 2
Arm/Group Title RPT450 RIF 600 RPT 600 Total
Hide Arm/Group Description

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

Rifampin 600mg daily

Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks

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 of all reporting groups
Overall Number of Baseline Participants 54 48 51 153
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 54 participants 48 participants 51 participants 153 participants
29
(23 to 39)
30
(25 to 36)
29
(24 to 38)
29
(24 to 38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 48 participants 51 participants 153 participants
Female
13
  24.1%
13
  27.1%
11
  21.6%
37
  24.2%
Male
41
  75.9%
35
  72.9%
40
  78.4%
116
  75.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 48 participants 51 participants 153 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
54
 100.0%
48
 100.0%
51
 100.0%
153
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Africa Number Analyzed 54 participants 48 participants 51 participants 153 participants
54 48 51 153
1.Primary Outcome
Title Percentage of Participants With Negative Lowenstein Jensen Cultures at Week 8
Hide Description [Not Specified]
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title RPT450 RIF 600 RPT 600
Hide Arm/Group Description:

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

Rifampin 600mg daily

Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks

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 Number of Participants Analyzed 41 36 45
Measure Type: Number
Unit of Measure: percentage of participants w/LJ cx con
85 94 96
2.Primary Outcome
Title Tolerability
Hide Description percentage of participants discontinuing assigned treatment
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
safety analysis population
Arm/Group Title RPT450 RIF 600 RPT 600
Hide Arm/Group Description:

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

Rifampin 600mg daily

Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks

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 Number of Participants Analyzed 54 48 51
Measure Type: Number
Unit of Measure: percentage of participants
2.0 8.3 2.0
3.Secondary Outcome
Title Time to Stable Culture Conversion on Solid Medium
Hide Description Time to stable culture conversion (in days) on Lowenstein Jensen solid medium
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected on some participants due to loss to follow up
Arm/Group Title RPT450 RIF 600 RPT 600
Hide Arm/Group Description:

Rifapentine 450mg daily

Rifapentine 450: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks

Rifampin 600mg daily

Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks

Rifapentine 600mg daily

Rifapentine 600: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks

Overall Number of Participants Analyzed 41 36 45
Median (Inter-Quartile Range)
Unit of Measure: days
37
(29 to 57)
43
(29 to 52)
36
(29 to 50)
4.Secondary Outcome
Title Time to Stable Culture Conversion on Liquid MGIT Media
Hide Description Time (in days) to stable culture conversion on liquid MGIT media
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RPT450 RIF 600 RPT 600
Hide Arm/Group Description:

Rifapentine 450mg daily

Rifapentine 450: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks

Rifampin 600mg daily

Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks

Rifapentine 600mg daily

Rifapentine 600: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks

Overall Number of Participants Analyzed 31 46 45
Median (Inter-Quartile Range)
Unit of Measure: days
50
(38 to 61)
59
(36 to 63)
57
(43 to 62)
5.Secondary Outcome
Title Pharmacokinetics of Rifapentine
Hide Description 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
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rifapentine 450 mg Rifapentine 600 mg
Hide Arm/Group Description:
Rifapentine 450 mg
Rifapentine 600 mg
Overall Number of Participants Analyzed 36 45
Median (Inter-Quartile Range)
Unit of Measure: ug x h/ml
330
(271 to 396)
435
(294 to 504)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RPT450 RIF 600 RPT 600
Hide Arm/Group Description

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

Rifampin 600mg daily

Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks

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

All-Cause Mortality
RPT450 RIF 600 RPT 600
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
RPT450 RIF 600 RPT 600
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   2/48 (4.17%)   0/51 (0.00%) 
Infections and infestations       
hospitalization * [1]  0/54 (0.00%)  1/48 (2.08%)  0/51 (0.00%) 
Psychiatric disorders       
hospitalization for psychosis *  0/54 (0.00%)  1/48 (2.08%)  0/51 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
hospitalization for lower respiratory tract infection
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
RPT450 RIF 600 RPT 600
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   2/48 (4.17%)   1/51 (1.96%) 
Hepatobiliary disorders       
hepatotoxicity *  0/54 (0.00%)  2/48 (4.17%)  1/51 (1.96%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan Dorman
Organization: Johns Hopkins University
Phone: 410-955-1755
EMail: dsusan1@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00814671    
Other Study ID Numbers: NA_00019095
First Submitted: December 24, 2008
First Posted: December 25, 2008
Results First Submitted: August 3, 2016
Results First Posted: September 28, 2016
Last Update Posted: February 6, 2018