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Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI (ASTERoiD)

Primary Purpose

Latent Tuberculosis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rifapentine daily for 6 weeks
Rifapentine and Isoniazid weekly for 12 weeks
Rifampin and Isoniazid daily for 12 weeks
Rifampin daily for 16 weeks
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Latent Tuberculosis focused on measuring latent tuberculosis, rifapentine

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males or non-pregnant, non-breastfeeding females > 12 years old. Women of child-bearing potential who are not surgically sterilized must agree to practice an adequate method of contraception (barrier method or non-hormonal intrauterine device) or abstain from heterosexual intercourse during study drug treatment.

  • Persons with LTBI who do not have evidence of TB disease and are at increased risk of progression to TB. M. tuberculosis infection may be demonstrated by either a positive tuberculin skin test (TST) or a positive interferon gamma release assay (IGRA; e.g., QuantiFERON or T.SPOT.TB). Persons with LTBI at increased risk of progression to TB are those with one of the following:

    1. Household and other close contacts (> 4 hours of exposure in a one week period) within 2 years prior to enrollment, of persons with culture-confirmed TB A positive nucleic acid amplification test (NAAT)/GeneXpert in the source case may be used for enrollment prior to culture confirmation
    2. Recent M. tuberculosis infection, defined as converting from a documented negative to positive TST or IGRA within 2 years prior to enrollment. Persons without known close contact to someone with active pulmonary TB who have a conversion by IGRA may require additional evaluation to rule out a false conversion.
    3. HIV co-infection.
    4. ≥ 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of treatment for TB or LTBI.
    5. Recent (within 2 years prior to enrollment) immigration to the United States, United Kingdom, or other country with low to moderate TB incidence, with abnormal chest X-ray, and no evidence of active TB.
    6. Recent (within 2 years prior to enrollment) immigration to the United States, United Kingdom, or other country with low to moderate TB incidence, from a country with an estimated incidence rate of TB > 150 per 100,000 (see Appendix D).
    7. An increased risk of TB due to medical conditions such as end-stage renal disease, or due to use of immunosuppressive medications such as chronic steroids or TNF-alpha inhibitors.
  • HIV-infected persons who are close contacts of a TB case, regardless of TST or IGRA result.
  • Willing to provide signed informed consent, or parental permission and participant assent.

Exclusion Criteria:

  • Current confirmed culture-positive or clinical TB.
  • Suspected current TB. Includes cases in which active TB cannot be eliminated as a possibility (by the site investigator)
  • TB resistant to any rifamycin in the source case
  • A history of treatment for > 7 consecutive days with a rifamycin or > 30 consecutive days with INH within 2 years prior to enrollment.
  • A documented history of completing an adequate course of treatment for TB disease or LTBI in a person who is HIV-seronegative.
  • History of allergy or intolerance to rifamycins.
  • Serum alanine aminotransferase (ALT; SGPT) or serum aspartate aminotransferase (AST; SGOT) > 5x upper limit of normal among persons in whom baseline ALT or AST is determined+.
  • HIV-seropositive and on antiretroviral therapy that cannot be given with rifampin or rifapentine due to drug-drug interactions.
  • Receiving concomitant medications that are known to be contraindicated with any study drug.
  • Females who are currently pregnant, breastfeeding, or intend to become pregnant within 120 days of enrollment.
  • Weight < 25 kg.

Sites / Locations

  • Denver Health and Hospital AuthorityRecruiting
  • George Washington UniversityRecruiting
  • Washington DC VA Medical CenterRecruiting
  • New York Harbor Healthcare SystemRecruiting
  • New York City Bureau of TB ControlRecruiting
  • San Antonio VARecruiting
  • Seattle King County Health DepartmentRecruiting
  • Liverpool HospitalRecruiting
  • Paramatta ChestRecruiting
  • Royal Prince Alfred HospitalRecruiting
  • Calgary TB ClinicRecruiting
  • Edmonton TB ClinicRecruiting
  • British Columbia Centre for Disease ControlRecruiting
  • Toronto Western HospitalRecruiting
  • McGill University Health CentreRecruiting
  • Desmond Tutu TB Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

6 weeks of daily rifapentine (6wP)

12-16 week rifamycin-based regimen

Arm Description

Rifapentine daily for 6 weeks: 600 mg of Rifapentine (RPT) given once daily for 6 weeks

A 12-16 week rifamycin-based regimen available at the participant's site: "Rifapentine and Isoniazid weekly for 12 weeks" (3HP) or "Rifampin and Isoniazid daily for 12 weeks" (3HR) or "Rifampin daily for 16 weeks" (4R)

Outcomes

Primary Outcome Measures

Treatment discontinuation due to adverse drug reaction
Safety outcome. Drug discontinuation due to adverse drug reaction (ADR) associated with experimental treatment (6wP) or active comparator treatment (the rifamycin-based 3HP, 3HR, or 4R). Attribution of an adverse event (AE) to study drugs will be initially determined by the local site investigator, reviewed by an independent, blinded adjudication panel and with final attribution determined by the sponsor.
Culture-confirmed tuberculosis (TB) in participants 18 years old and older and culture-confirmed or clinical TB in participants less then 18 years old.
Effectiveness outcome. Culture-confirmed tuberculosis (TB) in participants 18 years old and older and culture-confirmed or clinical TB in participants less then 18 years old. Diagnosis of culture-confirmed TB will be performed using liquid and/or solid media methods.

Secondary Outcome Measures

Proportion who complete assigned treatment
Proportion with drug discontinuation for any reason
Proportion with any grade 3, 4, or 5 (i.e., death) adverse event associated with study drug
Proportion who have died for any reason
Proportion with hepatitis and non-hepatotoxic systemic drug reactions
Proportion with culture-confirmed or clinical TB regardless of age
Proportion with TB among those who complete assigned therapy
Safety (defined as treatment discontinuation due to adverse drug reaction) among participants with human immunodeficiency virus (HIV) infection.
Proportion of HIV-infected patients with drug discontinuation due to adverse drug reaction (ADR) associated with experimental treatment (6wP) or active comparator treatment (the rifamycin-based 3HP, 3HR, or 4R) . Attribution of an adverse event (AE) to study drugs will be determined by the local site investigator.
Safety (defined as treatment discontinuation due to adverse drug reaction) among participants < 18 years old.
Proportion of participants < 18 years old with drug discontinuation due to adverse drug reaction (ADR) associated with experimental treatment (6wP) or active comparator treatment (the rifamycin-based 3HP, 3HR, or 4R) . Attribution of an adverse event (AE) to study drugs will be determined by the local site investigator.
Tolerability (defined as proportion of with drug discontinuation for any reason) among participants with human immunodeficiency virus (HIV) infection.
Proportion of HIV-infected patients with drug discontinuation for any reason
Tolerability (defined as proportion of with drug discontinuation for any reason) among participants < 18 years old.
Proportion of participants < 18 years old with drug discontinuation for any reason
Effectiveness among participants with human immunodeficiency virus (HIV) infection.
Proportion of HIV-infected patients with culture-confirmed tuberculosis (TB) in participants 18 years old and older and culture-confirmed or clinical TB in participants less then 18 years old. Diagnosis of culture-confirmed TB will be performed using liquid and/or solid media methods.
Effectiveness among participants < 18 years old.
Proportion of participants < 18 years old with culture-confirmed tuberculosis or clinical TB. Diagnosis of culture-confirmed TB will be performed using liquid and/or solid media methods.

Full Information

First Posted
March 8, 2018
Last Updated
July 10, 2023
Sponsor
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT03474029
Brief Title
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
Acronym
ASTERoiD
Official Title
Six Weeks of Daily Rifapentine vs. a Comparator Arm of 12-16 Week Rifamycin-based Treatment of Latent M. Tuberculosis Infection: Assessment of Safety, Tolerability and Effectiveness
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection (LTBI). This trial is conducted among persons who are at increased risk of progression to tuberculosis (TB) and require treatment of LTBI. The study will be conducted in low, medium and high TB incidence settings that have treatment of LTBI as their standard of care and offer 12-16 week rifamycin-based therapy as standard of care. The hypothesis of this study is that the safety and effectiveness of the experimental treatment (6wP arm) is non-inferior to a comparator arm of 12-16 weeks of rifamycin-based treatment of LTBI (control arm). Participants are enrolled and randomly assigned to one of the two study arms: experimental 6wP or control. The comparator (control) arm's treatment regimens include 12 weeks of once-weekly isoniazid (INH) and rifapentine (3HP), 12 weeks of daily INH and rifampin (3HR), and 16 weeks of daily rifampin (4R). A total of 560 participants per arm (1,120 total) for the evaluation of safety and 1,700 participants per arm (3,400 total) for the evaluation of effectiveness will be enrolled, given treatment as per randomization assignment, and followed for 24 months from the date of enrollment. After completion of data collection, statistical analyses will be conducted to compare proportions of drug discontinuation due to adverse drug reaction (ADR) and proportions of newly diagnosed tuberculosis between 6wP and control arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis
Keywords
latent tuberculosis, rifapentine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
6 weeks of daily rifapentine (6wP)
Arm Type
Experimental
Arm Description
Rifapentine daily for 6 weeks: 600 mg of Rifapentine (RPT) given once daily for 6 weeks
Arm Title
12-16 week rifamycin-based regimen
Arm Type
Active Comparator
Arm Description
A 12-16 week rifamycin-based regimen available at the participant's site: "Rifapentine and Isoniazid weekly for 12 weeks" (3HP) or "Rifampin and Isoniazid daily for 12 weeks" (3HR) or "Rifampin daily for 16 weeks" (4R)
Intervention Type
Drug
Intervention Name(s)
Rifapentine daily for 6 weeks
Other Intervention Name(s)
priftin
Intervention Description
600 mg of Rifapentine (RPT) given once daily (o.d., omni die) for 6 weeks (6wP).
Intervention Type
Drug
Intervention Name(s)
Rifapentine and Isoniazid weekly for 12 weeks
Intervention Description
Rifapentine (RPT) 900 mg and isoniazid (INH) 900 mg given once-weekly for 12 weeks (3HP).* *Dose adjustments based on patient's weight will be made according to ATS/CDC/IDSA guidelines. RPT 900 mg once-weekly for persons weighing > 50 kg. For persons weighing < 50 kg, the following doses will be given: weight > 25-32 kg - RPT 600 mg; weight > 32-50 kg - RPT 750 mg; + INH 15 mg/kg (round up to nearest 50 or 100 mg; 900 mg max).
Intervention Type
Drug
Intervention Name(s)
Rifampin and Isoniazid daily for 12 weeks
Intervention Description
Rifampin (RIF) 600 mg and Isoniazid (INH) 300 mg given once-daily for 12 weeks (3HR)*. *Dose adjustments based on patient's weight will be made according to ATS/CDC/IDSA guidelines. RIF 600 mg daily for persons weighing > 50 kg. For persons weighing < 50 kg, give 10 mg/kg daily; round up to nearest 50 or 100 mg; + INH 5 mg/kg daily (rounded up to nearest 50 or 100 mg; 300 mg max).
Intervention Type
Drug
Intervention Name(s)
Rifampin daily for 16 weeks
Intervention Description
Rifampin (RIF) 600 mg given once-daily for 16 weeks (4R).* *Dose adjustments based on patient's weight will be made according to ATS/CDC/IDSA guidelines. RIF 600 mg daily for persons weighing > 50 kg. For persons weighing < 50 kg, 10 mg/kg daily; round up to nearest 50 or 100 mg.
Primary Outcome Measure Information:
Title
Treatment discontinuation due to adverse drug reaction
Description
Safety outcome. Drug discontinuation due to adverse drug reaction (ADR) associated with experimental treatment (6wP) or active comparator treatment (the rifamycin-based 3HP, 3HR, or 4R). Attribution of an adverse event (AE) to study drugs will be initially determined by the local site investigator, reviewed by an independent, blinded adjudication panel and with final attribution determined by the sponsor.
Time Frame
from the date of enrollment to the date of scheduled completion of assigned treatment
Title
Culture-confirmed tuberculosis (TB) in participants 18 years old and older and culture-confirmed or clinical TB in participants less then 18 years old.
Description
Effectiveness outcome. Culture-confirmed tuberculosis (TB) in participants 18 years old and older and culture-confirmed or clinical TB in participants less then 18 years old. Diagnosis of culture-confirmed TB will be performed using liquid and/or solid media methods.
Time Frame
within 24 months from the date of enrollment
Secondary Outcome Measure Information:
Title
Proportion who complete assigned treatment
Time Frame
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Title
Proportion with drug discontinuation for any reason
Time Frame
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Title
Proportion with any grade 3, 4, or 5 (i.e., death) adverse event associated with study drug
Time Frame
within 6 months from the date of enrollment
Title
Proportion who have died for any reason
Time Frame
within 24 months from the date of enrollment
Title
Proportion with hepatitis and non-hepatotoxic systemic drug reactions
Time Frame
within 6 months from the date of enrollment
Title
Proportion with culture-confirmed or clinical TB regardless of age
Time Frame
within 24 months from the date of enrollment
Title
Proportion with TB among those who complete assigned therapy
Time Frame
within 24 months from the date of enrollment
Title
Safety (defined as treatment discontinuation due to adverse drug reaction) among participants with human immunodeficiency virus (HIV) infection.
Description
Proportion of HIV-infected patients with drug discontinuation due to adverse drug reaction (ADR) associated with experimental treatment (6wP) or active comparator treatment (the rifamycin-based 3HP, 3HR, or 4R) . Attribution of an adverse event (AE) to study drugs will be determined by the local site investigator.
Time Frame
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Title
Safety (defined as treatment discontinuation due to adverse drug reaction) among participants < 18 years old.
Description
Proportion of participants < 18 years old with drug discontinuation due to adverse drug reaction (ADR) associated with experimental treatment (6wP) or active comparator treatment (the rifamycin-based 3HP, 3HR, or 4R) . Attribution of an adverse event (AE) to study drugs will be determined by the local site investigator.
Time Frame
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Title
Tolerability (defined as proportion of with drug discontinuation for any reason) among participants with human immunodeficiency virus (HIV) infection.
Description
Proportion of HIV-infected patients with drug discontinuation for any reason
Time Frame
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Title
Tolerability (defined as proportion of with drug discontinuation for any reason) among participants < 18 years old.
Description
Proportion of participants < 18 years old with drug discontinuation for any reason
Time Frame
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Title
Effectiveness among participants with human immunodeficiency virus (HIV) infection.
Description
Proportion of HIV-infected patients with culture-confirmed tuberculosis (TB) in participants 18 years old and older and culture-confirmed or clinical TB in participants less then 18 years old. Diagnosis of culture-confirmed TB will be performed using liquid and/or solid media methods.
Time Frame
within 24 months from the date of enrollment
Title
Effectiveness among participants < 18 years old.
Description
Proportion of participants < 18 years old with culture-confirmed tuberculosis or clinical TB. Diagnosis of culture-confirmed TB will be performed using liquid and/or solid media methods.
Time Frame
within 24 months from the date of enrollment
Other Pre-specified Outcome Measures:
Title
Proportions of drug discontinuation due to adverse drug reactions in experimental (6wP) arm and each treatment regimen in the comparator arm: 3HP, 3HR, 4R
Time Frame
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Title
Proportions of treatment discontinuations for any reason in experimental (6wP) arm and each treatment regimen in the comparator arm: 3HP, 3HR, 4R
Time Frame
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Title
Effectiveness of experimental (6wP) arm and each treatment regimen in the comparator arm: 3HP, 3HR, 4R
Description
Proportion of participants with culture-confirmed tuberculosis (TB) in participants 18 years old and older and culture-confirmed or clinical TB in participants less then 18 years old. Diagnosis of culture-confirmed TB will be performed using liquid and/or solid media methods.
Time Frame
within 24 months from the date of enrollment
Title
Proportion with resistance to rifamycins or isoniazid among persons who develop TB to each regimen in the comparator arm: 3HP, 3HR, 4R.
Time Frame
within 24 months from the date of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or non-pregnant, non-breastfeeding females > 12 years old. Women of child-bearing potential who are not surgically sterilized must agree to practice an adequate method of contraception (barrier method or non-hormonal intrauterine device) or abstain from heterosexual intercourse during study drug treatment. Persons with LTBI who do not have evidence of TB disease and are at increased risk of progression to TB. M. tuberculosis infection may be demonstrated by either a positive tuberculin skin test (TST) or a positive interferon gamma release assay (IGRA; e.g., QuantiFERON or T.SPOT.TB). Persons with LTBI at increased risk of progression to TB are those with one of the following: Household and other close contacts (> 4 hours of exposure in a one week period) within 2 years prior to enrollment, of persons with culture-confirmed TB A positive nucleic acid amplification test (NAAT)/GeneXpert in the source case may be used for enrollment prior to culture confirmation Recent M. tuberculosis infection, defined as converting from a documented negative to positive TST or IGRA within 2 years prior to enrollment. Persons without known close contact to someone with active pulmonary TB who have a conversion by IGRA may require additional evaluation to rule out a false conversion. HIV co-infection (with CD4+ T-lymphocyte count > 100 cells/mm3). ≥ 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of treatment for TB or LTBI. Recent (within 3 years prior to enrollment) immigration to the United States or other country with low to moderate TB incidence, with abnormal chest X-ray, and no evidence of active TB. Recent (within 2 years prior to enrollment) immigration to the United States or other country with low to moderate TB incidence, from a country with an estimated incidence rate of TB > 150 per 100,000 An increased risk of TB due to medical conditions such as end-stage renal disease, or due to use of immunosuppressive medications such as chronic steroids or TNF-alpha inhibitors. Willing to provide signed informed consent, or parental permission and participant assent. Exclusion Criteria: Current confirmed culture-positive or clinical TB. Suspected current TB. Includes cases in which active TB cannot be eliminated as a possibility (by the site investigator) TB resistant to any rifamycin in the source case A history of treatment for > 7 consecutive days with a rifamycin or > 30 consecutive days with INH within 2 years prior to enrollment. A documented history of completing an adequate course of treatment for TB disease or LTBI in a person who is HIV-seronegative. History of allergy or intolerance to rifamycins. Serum alanine aminotransferase (ALT; SGPT) or serum aspartate aminotransferase (AST; SGOT) > 5x upper limit of normal among persons in whom baseline ALT or AST is determined+. HIV-seropositive and on antiretroviral therapy that cannot be given with rifampin or rifapentine due to drug-drug interactions. Receiving concomitant medications that are known to be contraindicated with any study drug. Females who are currently pregnant, breastfeeding, or intend to become pregnant within 120 days of enrollment. Weight < 25 kg.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosanna M Boyd, PhD
Phone
+1 (404)-553-7434
Email
icg7@cdc.gov
First Name & Middle Initial & Last Name or Official Title & Degree
TBTC Research Administrator
Phone
+1 (800)-232-4636
Email
tbtcresearchadmin@cdc.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Sterling, MD
Organizational Affiliation
Vanderbilt University Medical Center, USA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Robert Belknap, MD
Organizational Affiliation
Denver Public Health (USA)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amber Robinson, PhD
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rosanna M Boyd, PhD
Organizational Affiliation
Centers for Disease Control (USA)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dick Menzies, MD
Organizational Affiliation
McGill University
Official's Role
Study Chair
Facility Information:
Facility Name
Denver Health and Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Belknap, MD
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afsoon Roberts, MD
Facility Name
Washington DC VA Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Benator, MD
Facility Name
New York Harbor Healthcare System
City
Manhattan
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Wu, MD
Facility Name
New York City Bureau of TB Control
City
New York
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Burzynski, MD
Facility Name
San Antonio VA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Cadena, MD
Facility Name
Seattle King County Health Department
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masa Narita, MD
Facility Name
Liverpool Hospital
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zinta Harrington, MD
Facility Name
Paramatta Chest
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Gun Cho, MD
Facility Name
Royal Prince Alfred Hospital
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Greg Fox, MD
Facility Name
Calgary TB Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6H6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina Fisher, MD
Facility Name
Edmonton TB Clinic
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Long, MD
Facility Name
British Columbia Centre for Disease Control
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Johnston, MD
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5P 1N5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Brode, MD
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 0G4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dick Menzies, MD
Facility Name
Desmond Tutu TB Center
City
Stellenbosch
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anneke Hesseling, MD

12. IPD Sharing Statement

Links:
URL
https://www.cdc.gov/tb/topic/research/tbtc/default.htm
Description
Tuberculosis Trials Consortium (TBTC)

Learn more about this trial

Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI

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