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Ultra Curto (Ultra Short) TB Prevention Therapy

CompletedPhase 4

Sponsor: Johns Hopkins University

Conditions: Tuberculosis

Interventions: Rifapentine 600 mg and INH 300 mg, Rifapentine 900 mg and INH 900 mg

Countries: Brazil

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.

Eligibility overview

Sex: ALL

Age: 15 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Locations (2)

Manaus, Amazonas, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil