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Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection (PREVENT TB)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Department of Veterans Affairs
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00023452
First received: September 6, 2001
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
Results First Received: August 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Tuberculosis
Interventions: Drug: RPT + INH once weekly for 3 months given by DOT
Drug: Isoniazid (INH) daily for 9 months

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The protocol design allowed enrollment of participants identified as members of the same household or group setting (such as group homes, settings) in clusters. The same treatment regimen to which a first participant was randomized could be assigned to other cluster members. All other participants enrolled were randomized individually.

Reporting Groups
  Description
9INH Participants who were high-risk tuberculin skin test (TST) reactors (household and other close contacts of active tuberculosis [TB] cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on chest x-ray [CXR], human immunodeficiency virus [HIV] infected participants) self-administered oral isoniazid (INH) tablets (aged greater than or equal to [≥12] years of age received 5 milligrams per kilogram [mg/kg] and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
3RPT/INH Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral rifapentine (RPT) tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by Directly Observed Therapy (DOT), defined as a healthcare worker observing ingestion of each dose of RPT and INH.

Participant Flow:   Overall Study
    9INH     3RPT/INH  
STARTED     3908     4145  
Randomized     3190     3174  
Enrolled as Part of a Cluster     718     971  
Completed Treatment     2585     3273  
Not Treated     149     105  
Completed Study     3174     3475  
COMPLETED     2585     3273  
NOT COMPLETED     1323     872  
Ineligible for Study                 163                 159  
Out of Window                 129                 69  
Death                 2                 0  
Withdrawal by Subject                 66                 54  
Adverse Event                 139                 196  
Lost to Follow-up                 293                 60  
Physician Decision                 49                 21  
Refused Treatment (continued follow-up)                 225                 224  
Pregnant                 53                 20  
Unknown                 204                 69  



  Baseline Characteristics
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Reporting Groups
  Description
9INH Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
3RPT/INH Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
Total Total of all reporting groups

Baseline Measures
    9INH     3RPT/INH     Total  
Number of Participants  
[units: participants]
 		  3908     4145     8053  
Age  
[units: years]
Median ( Inter-Quartile Range ) 		  35  
  ( 25 to 46 )   		  36  
  ( 25 to 47 )   		  35  
  ( 25 to 47 )  
Gender, Customized  
[units: participants]
 		     
Female     1812     1847     3659  
Male     2096     2297     4393  
Missing     0     1     1  



  Outcome Measures
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1.  Primary:   Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment   [ Time Frame: Baseline up to Month 33 ]
  Show Outcome Measure 1

2.  Secondary:   Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants <18 Years of Age at 24 Months Following Completion of Study Therapy   [ Time Frame: Baseline up to Month 27 (3RPT/INH) or Month 33 (9INH) ]
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3.  Secondary:   Cumulative Rate of Culture-Confirmed or Probable (Clinical) TB Disease (Regardless of Age) At 33 Months After Enrollment   [ Time Frame: Baseline up to 33 Months ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants With Drug Discontinuation Due to Adverse Drug Reactions Associated With 3RPT/INH or 9INH   [ Time Frame: Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH]) ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Patients With Grade 3 or 4 Drug Toxicities Associated With 3RPT/INH or 9INH   [ Time Frame: Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH]) ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants With Death Due to Any Cause   [ Time Frame: Baseline up to Month 35 ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants With Drug Discontinuation for Any Reason Associated With 3RPT/INH or 9INH   [ Time Frame: Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH) ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants Who Completed the Treatment Regimen   [ Time Frame: Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH) ]
  Show Outcome Measure 8

9.  Secondary:   Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture Confirmed or Probable (Clinical) TB Disease Among Participants <18 Years of Age Who Completed Study Phase Therapy Within 33 Months of Enrollment   [ Time Frame: Baseline up to Month 33 ]
  Show Outcome Measure 9

10.  Secondary:   Percentage of Participants With Resistance to Study Medications in Isolates of MTB From Participants Who Developed Active TB Disease Within 33 Months of Enrollment   [ Time Frame: Baseline up to Month 33 ]
  Show Outcome Measure 10

11.  Secondary:   Percentage of Participants With Methadone Withdrawal Associated With 3RPT/INH and 9INH Among Participants Receiving Concomitant Methadone   [ Time Frame: Baseline to Month 33 ]
Results not yet posted.   Anticipated Posting Date:   12/2013   Safety Issue:   Yes

12.  Secondary:   Cumulative Rate of Culture-Confirmed or Probable TB Disease in HIV-Infected Participants Within 33 Months After Enrollment   [ Time Frame: Baseline to Month 33 ]
Results not yet posted.   Anticipated Posting Date:   12/2013   Safety Issue:   No

13.  Secondary:   Cumulative Rate of HIV-Infected Participants With Culture-Confirmed or Probable TB Disease at 24 Months After Completion of Study Therapy   [ Time Frame: Baseline up to Month 27 (3RPT/INH) or Month 33 (9INH) ]
Results not yet posted.   Anticipated Posting Date:   12/2013   Safety Issue:   No

14.  Secondary:   Cumulative Rate of Participants <18 Years Old With Culture-Confirmed or Probable (Clinical) TB Disease Within 33 Months of Enrollment   [ Time Frame: Baseline up to Month 33 ]
Results not yet posted.   Anticipated Posting Date:   12/2013   Safety Issue:   No

15.  Secondary:   Cumulative Rate of Participants <12 Years Old With Culture-Confirmed or Probable (Clinical) TB Disease Within 33 Months of Enrollment   [ Time Frame: Baseline up to Month 33 ]
Results not yet posted.   Anticipated Posting Date:   12/2013   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr Elsa Villarino
Organization: CDC
phone: 404-639-5340
e-mail: mev1@cdc.gov


Publications of Results:


Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00023452     History of Changes
Other Study ID Numbers: CDC-NCHSTP-3041, CDC TBTC Study 26
Study First Received: September 6, 2001
Results First Received: August 15, 2012
Last Updated: August 28, 2012
Health Authority: United States: Food and Drug Administration