CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 531 enrolled
Drug / intervention
Rifapentine 600 mg and INH 300 mg +1 moredrug
Likely dose
Rifapentine 600 mg and INH 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04703075
NCT04703075Phase 4Completed
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Safety and Tolerability of Ultra-short Course Rifapentine and Isoniazid (1HP) for Prevention of Tuberculosis in HIV-Uninfected Individuals

Johns Hopkins University·interventional·Posted Jan 11, 2021·Updated Jun 19, 2025

In Brief

A Phase 4 clinical trial evaluating Rifapentine 600 mg and INH 300 mg and Rifapentine 900 mg and INH 900 mg for Tuberculosis. Completed, enrolled 531 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesBrazil
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID), Sanofi

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJan 11, 2021
Enrollment StartMar 24, 2022
Primary CompletionJun 10, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.5 years ago

Interventions

Rifapentine 600 mg and INH 300 mgdrug

Participants will receive Rifapentine 600 mg and INH 300 mg

Rifapentine 900 mg and INH 900 mgdrug

Participants will receive Rifapentine 900 mg and INH 900mg