Status:
RECRUITING
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
Lead Sponsor:
Centers for Disease Control and Prevention
Conditions:
Latent Tuberculosis
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
3400 Patients enrolled
Trial Details
Trial ID
NCT03474029
Start Date
August 1 2019
End Date
December 1 2029
Last Update
September 26 2024
Active Locations (16)
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1
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
2
George Washington University
Washington D.C., District of Columbia, United States, 20001
3
Washington DC VA Medical Center
Washington D.C., District of Columbia, United States, 20001
4
New York Harbor Healthcare System
Manhattan, New York, United States, 10001