Status:
COMPLETED
Ultra Curto (Ultra Short) TB Prevention Therapy
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Sanofi
Conditions:
Tuberculosis
Eligibility:
All Genders
15-99 years
Phase:
PHASE4
Brief Summary
To compare treatment success (adherence and completion of treatment) and safety of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.
Detailed Description
Tuberculosis (TB) is the leading infectious killer globally and a major cause of illness and suffering. The World Health Organization has prioritized TB preventive therapy (TPT) for people with latent...
Eligibility Criteria
Inclusion
- Positive tuberculin skin test or interferon-gamma release assay (IGRA) test and
- Household contact of an infectious TB case within previous 90 days, defined as sleeping at least once in a residence with a person diagnosed with pulmonary TB, or
- Documented conversion of Tuberculin skin test (TST)/IGRA from negative to positive within 2 years
Exclusion
- Documented HIV infection
- Evidence of active tuberculosis on clinical exam or chest x-ray
- Known intolerance of any study drug
- Treatment for active or latent TB in the past for more than 14 days
- Known close contact to someone with INH or rifampin resistant TB
- Active liver disease or Aspartate aminotransferase(AST)/Alanine transaminase (ALT) \>3 times upper limit of normal (ULN)
- Neutropenia (ANC \<1000)
- Peripheral neuropathy \>Grade 1 by DAIDS Grading Table
- Pregnant or breastfeeding. Women of childbearing potential must agree to use non-hormonal contraception during study treatment.
- Weight \<40 kg
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2024
Estimated Enrollment :
531 Patients enrolled
Trial Details
Trial ID
NCT04703075
Start Date
March 24 2022
End Date
June 10 2024
Last Update
June 19 2025
Active Locations (2)
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1
Fundacao de Medicina Tropical Doutor Heitor
Manaus, Amazonas, Brazil, 69040-000
2
NAPDOT
Rio de Janeiro, Rio de Janeiro, Brazil, 22450-221