Treatment Success and Safety of 4 Weeks of Daily Rifapentine and Isoniazid (1HP) vs. 12 Weeks of Weekly Rifapentine and Isoniazid (3HP) for Prevention of Tuberculosis in HIV-uninfected Individuals (1v3HP for TPT in HIV-uninfected Individuals)

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Rifampin; Rifapentine

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

• At risk of poor outcome based on clinical judgment and discretion of investigator.

• Required use of a prohibited medication with a serious drug-drug interaction with rifamycins or isoniazid.