Taima TB: 3HP Study

• Status: Completed
• Trial end date: 2019-08-15
• Target enrollment: 0
• Participant gender: All

Summary

This phase IV clinical study trial will be conducted among persons who require treatment for LTBI treatment in Iqaluit, Nunavut and Ottawa, Ontario. The primary objective of this study is to compare the proportion of people who complete directly observed prophylactic treatment (DOPT) using the new 3HP regimen to the current standard of 9 months INH.

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

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborators: Government of Canada; Government of Nunavut
• Treatments: Rifapentine

Criteria

Inclusion Criteria:

1. Males or non-pregnant, non-nursing females between the ages of 2-65 years

2. LTBI diagnosis as per Canadian TB Standards using either the Tuberculin Skin Test (TST) or the Interferon Gamma Release Assay (IGRA)

3. Children 2-5 years with negative TSTs who have been in close contact with a case of active TB disease recently

4. Able and willing to provide fully informed consent or parent/guardian able to provide consent

Exclusion Criteria:

1. Suspected or confirmed active TB disease

2. Known allergies to any of the study medications by participant self-report

3. Female participants of childbearing potential who:

1. have a positive pregnancy test at screening, or

2. are not willing to use a reliable method of barrier contraception during the study, or

3. are breastfeeding

4. Unable/unwilling to substitute medications with drug interactions with 3HP, including :

1. hormonal contraception

2. HIV infected participants who are on anti-retroviral drugs

3. other drugs that interact with 3HP (see Table 1)

5. Known contact with an INH or rifampin resistant case

6. Weight < 10 kg

7. Evidence of possible liver damage defined by an aspartate transaminase (AST) level that is more than 3x the upper limit of normal in an asymptomatic patient

8. Porphyria reported by patient

9. Inability to adhere to protocol.

10. Patients may be excluded from the study for other reasons, at the investigator's discretion with detailed documentation.