MedTrace Logo

Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)

NCT01404312 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2021-11-04

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Rifapentine (RPT)

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).

DRUG

Isoniazid (INH)

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

DIETARY_SUPPLEMENT

Pyridoxine (Vitamin B6)

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Richard E. Chaisson, MD · Johns Hopkins University

  • Susan Swindells, MBBS · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-23
Primary Completion
2017-11-14
Completion
2017-11-14

Countries

  • United States
  • Botswana
  • Brazil
  • Haiti
  • Kenya
  • Malawi
  • Peru
  • South Africa
  • Thailand
  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404312 on ClinicalTrials.gov