Evaluation of the Effect of 3HP vs Periodic 3HP vs 6H in HIV-Positive Individuals

• Status: Completed
• Trial end date: 2019-10-18
• Target enrollment: 0
• Participant gender: All

Summary

This study is a parallel, two part, open label, individually randomized, pragmatic trial among HIV-positive individuals. Part A compares a single round of weekly high dose rifapentine plus isoniazid for three months (3HP) to six months of daily isoniazid (6H). Part B compares periodic 3HP (p3HP) to a single round of 3HP.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: KNCV Tuberculosis Foundation; The Aurum Institute NPC
• Collaborators: Aurum Institute; Johns Hopkins University; London School of Hygiene and Tropical Medicine
• Treatments: Isoniazid; Rifampin; Rifapentine

Criteria

Inclusion Criteria:

• At least two years of age

• Known HIV infection

• Antiretroviral therapy (ART) ineligible or on ART for ≥3 months

Exclusion Criteria:

• Confirmed or suspected TB disease

• Likely to move from the study area during the study period

• Known exposure to TB cases with known or suspected resistance to isoniazid or rifampicin in the source case

• TB treatment within the past year

• TB preventive therapy within the last year

• Sensitivity or intolerance to isoniazid or rifamycins

• Suspected acute hepatitis or known chronic liver disease

• ALT/AST >5 times the upper limit of normal (regardless of symptoms of hepatitis)

• Pregnancy or breastfeeding

• Women of childbearing potential who are unable or unwilling to use contraception

• Self-reported alcohol use exceeding 28 units per week for men, or 21 units for women