CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,000 enrolled
Drug / intervention
Rifapentine (RPT) +2 moredrug
Likely dose
Rifapentine (RPT) 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/NCT01404312
NCT01404312Phase 3Completed
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Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals With Latent Tuberculosis Infection

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 28, 2011·Updated Nov 4, 2021

In Brief

A Phase 3 clinical trial evaluating Rifapentine (RPT), Isoniazid (INH), and 1 other intervention for Tuberculosis and HIV Infections. Completed, enrolled 3,000 participants across 45 sites in 10 countries.

Detailed Summary

HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active TB.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, HIV Infections
CountriesBotswana, Brazil, Haiti, Kenya, Malawi, Peru, South Africa, Thailand, United States, Zimbabwe
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 28, 2011
Enrollment StartMay 23, 2012
Primary CompletionNov 14, 2017
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 14.9 years ago

Interventions

Rifapentine (RPT)drug

RPT dosing was be based on participants' weight: Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets). Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets). Participants who weighed greater than 45 kg received 600 mg once daily (administered as four 150-mg tablets).

Isoniazid (INH)drug

Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.

Pyridoxine (Vitamin B6)dietary

Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines. Participants who received 25 mg of pyridoxine took one 25-mg tablet once daily with INH. Participants who received 50 mg of pyridoxine took two 25-mg tablets once daily with INH.