drugset / Trial / NCT05118490

Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients

NCT05118490

Phase 4 Active not recruiting 1000 enrolled The Aurum Institute NPC Johns Hopkins University · collab
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2023-07-19
Primary completion
2025-07-11
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Isoniazid Small molecule 300 mg
Subject Isoniazid Small molecule 900 mg
Subject Rifapentine Small molecule 600 mg
Subject Rifapentine Small molecule 900 mg