A Randomized Trial Comparing Treatment Completion of Daily Rifapentine & Isoniazid for One Month (1HP) To Weekly Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in HIV-negative Household Contacts of Recently Diagnosed Tuberculosis Patients, The "One To Three" Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 4
- Primary Endpoint
- Treatment adherence- pill count
Study Overview
Brief Summary
A multicenter, randomized, stratified, open-label, phase IV trial among HIV-positive persons (PLHIV) on antiretroviral therapy (ART), or HIV-negative household contacts of patients with rifampicin-sensitive pulmonary tuberculosis (TB), who do not have evidence of active TB.
Detailed Description
Participants will be stratified by indication for tuberculosis (TB) preventive treatment (TPT) - HIV seropositive persons or HIV-negative household contact of person with infectious TB - and will receive either one of two TB preventive therapy regimens:
Group 1: People living with HIV infection without active TB
Arm A: isoniazid (300mg) and rifapentine (600mg) daily for 4 weeks (1HP)
Arm B: isoniazid (900mg) and rifapentine (900mg) weekly for 12 weeks (3HP)
Arm A (n=250): 250 participants age ≥13 years of age who are HIV seropositive and taking ART who do not have evidence of active TB will be recruited from local clinics. After being consented, screened, and randomized, participants in Arm A will receive the 1HP regimen once daily for 4 weeks (28 doses).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1: People living with HIV infection without active TB
Intervention: Daily rifapentine and isoniazid for 4 weeks (Drug)
Group 1: People living with HIV infection without active TB
Intervention: Weekly rifapentine and isoniazid for 12 weeks (Drug)
Group 2: HIV-negative household contacts of adults with rifampicin-sensitive pulmonary TB
Intervention: Daily rifapentine and isoniazid for 4 weeks (Drug)
Group 2: HIV-negative household contacts of adults with rifampicin-sensitive pulmonary TB
Intervention: Weekly rifapentine and isoniazid for 12 weeks (Drug)
Outcomes
Primary Outcomes
Treatment adherence- pill count
Time Frame: from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2) , to be reported at end of trial
Completion of TPT with \>90% adherence documented by pill count (both groups, Arms A and B)
Treatment adherence- electronic monitoring device (EMD)
Time Frame: from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2) , to be reported at end of trial
Completion of TPT with \>90% adherence documented by pill count (both groups, Arms A and B)
Early treatment discontinuation
Time Frame: from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2), to be reported at end of trial
discontinuation of study medications because of side effects (both groups, Arms A and B)
Treatment adherence- self-report
Time Frame: from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2) , to be reported at end of trial
Completion of TPT with \>90% adherence documented by self-report (both groups, Arms A and B)
Adverse Events
Time Frame: from study entry at Day 0 through Month 6 (Week 24), to be reported at end of trial
Occurrence of Grade 2 or higher targeted safety events (both groups, Arms A and B). Targeted safety events are hypersensitivity syndrome, rash, seizure, peripheral neuropathy, hepatotoxicity, nausea and vomiting, and drug-related fever.
Secondary Outcomes
- Cost-effectiveness(from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2) , to be reported at end of trial)