At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
Rifapentine (RPT) +2 moredrug
Likely dose
Rifapentine (RPT) 900 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.
A Phase I/II Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-1-infected and HIV-1-uninfected Pregnant and Postpartum Women With Latent Tuberculosis Infection
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 8, 2016·Updated Nov 4, 2021
In Brief
A Phase 2 clinical trial evaluating Rifapentine (RPT), Isoniazid (INH), and 1 other intervention for Tuberculosis. Completed, enrolled 50 participants across 5 sites in 5 countries.
Detailed Summary
The purpose of this study was to evaluate the pharmacokinetics (PK), tolerability, and safety of once-weekly doses of rifapentine (RPT) and isoniazid (INH) in HIV-1-infected and HIV-1-uninfected pregnant and postpartum women with latent tuberculosis (TB).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesHaiti, Kenya, Malawi, Thailand, Zimbabwe
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartMar 2017
Primary CompletionApr 2019
TodayJul 2026
First PostedJan 8, 2016
Enrollment StartMar 13, 2017
Primary CompletionApr 10, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.5 years ago
Interventions
Rifapentine (RPT)drug
900 mg of RPT
Isoniazid (INH)drug
900 mg of INH
Pyridoxine (vitamin B6)dietary
25 mg to 100 mg of pyridoxine, based on the current local, national, or international dosing guidelines.