Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
NCT ID: NCT03474029
Last Updated: 2024-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
3400 participants
INTERVENTIONAL
2019-08-01
2029-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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6 weeks of daily rifapentine (6wP)
Rifapentine daily for 6 weeks: 600 mg of Rifapentine (RPT) given once daily for 6 weeks
Rifapentine daily for 6 weeks
600 mg of Rifapentine (RPT) given once daily (o.d., omni die) for 6 weeks (6wP).
12-16 week rifamycin-based regimen
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)
Rifapentine and Isoniazid weekly for 12 weeks
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).
Rifampin and Isoniazid daily for 12 weeks
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).
Rifampin daily for 16 weeks
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.
Interventions
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Rifapentine daily for 6 weeks
600 mg of Rifapentine (RPT) given once daily (o.d., omni die) for 6 weeks (6wP).
Rifapentine and Isoniazid weekly for 12 weeks
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).
Rifampin and Isoniazid daily for 12 weeks
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).
Rifampin daily for 16 weeks
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 (with CD4+ T-lymphocyte count \> 100 cells/mm3).
4. ≥ 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of treatment for TB or LTBI.
5. 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.
6. 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
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.
* Willing to provide signed informed consent, or parental permission and participant assent.
Exclusion Criteria
* 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.
12 Years
ALL
No
Sponsors
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Centers for Disease Control and Prevention
FED
Responsible Party
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Principal Investigators
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Timothy Sterling, MD
Role: STUDY_CHAIR
Vanderbilt University Medical Center, USA
Robert Belknap, MD
Role: STUDY_CHAIR
Denver Public Health (USA)
Amber Robinson, PhD
Role: STUDY_DIRECTOR
Centers for Disease Control and Prevention
Rosanna M Boyd, PhD
Role: STUDY_DIRECTOR
Centers for Disease Control (USA)
Dick Menzies, MD
Role: STUDY_CHAIR
McGill University
Locations
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Denver Health and Hospital Authority
Denver, Colorado, United States
George Washington University
Washington D.C., District of Columbia, United States
Washington DC VA Medical Center
Washington D.C., District of Columbia, United States
New York Harbor Healthcare System
Manhattan, New York, United States
New York City Bureau of TB Control
New York, New York, United States
San Antonio VA
San Antonio, Texas, United States
Seattle King County Health Department
Seattle, Washington, United States
Liverpool Hospital
Sydney, , Australia
Paramatta Chest
Sydney, , Australia
Royal Prince Alfred Hospital
Sydney, , Australia
Calgary TB Clinic
Calgary, Alberta, Canada
Edmonton TB Clinic
Edmonton, Alberta, Canada
British Columbia Centre for Disease Control
Vancouver, British Columbia, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Desmond Tutu TB Center
Stellenbosch, , South Africa
Countries
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Central Contacts
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Facility Contacts
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Robert Belknap, MD
Role: primary
Afsoon Roberts, MD
Role: primary
Debra Benator, MD
Role: primary
Benjamin Wu, MD
Role: primary
Joseph Burzynski, MD
Role: primary
Jose Cadena, MD
Role: primary
Masa Narita, MD
Role: primary
Zinta Harrington, MD
Role: primary
Jin-Gun Cho, MD
Role: primary
Greg Fox, MD
Role: primary
Dina Fisher, MD
Role: primary
Richard Long, MD
Role: primary
James Johnston, MD
Role: primary
Sarah Brode, MD
Role: primary
Dick Menzies, MD
Role: primary
Anneke Hesseling, MD
Role: primary
Related Links
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Tuberculosis Trials Consortium (TBTC)
Other Identifiers
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CDC-NCHSTP-7024
Identifier Type: -
Identifier Source: org_study_id
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