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TBTC Study 29: Rifapentine During Intensive Phase Tuberculosis (TB) Treatment

NCT00694629 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2026-08-13

Study results available
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Summary

This Phase 2, multicenter, open-label clinical trial evaluated the antimicrobial activity and safety of rifapentine-containing regimens during the intensive phase of pulmonary tuberculosis treatment.

Participants were randomized to receive either a standard rifampin-based regimen (RHZE) or a rifapentine-substituted regimen (PHZE). An extension study evaluated higher daily doses of rifapentine (10, 15, and 20 mg/kg).

The primary endpoint was sputum culture conversion at 8 weeks. Secondary outcomes included time to culture conversion, safety, and treatment discontinuation.

Conditions

  • Pulmonary Tuberculosis

Interventions

DRUG

rifapentine

tablet, 10 mg/kg, daily, 8 weeks

DRUG

rifapentine 10 mg/kg

tablet, 10 mg/kg, daily, 8 weeks

DRUG

rifapentine 15 mg/kg

tablet, 15 mg/kg, daily, 8 weeks

DRUG

rifapentine 20 mg/kg

20 mg/kg, daily, 8 weeks

Sponsors & Collaborators

Principal Investigators

  • Susan Dorman, MD · Johns Hopkins University

  • Neil Schluger, MD · Columbia University

  • Jason Stout, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2013-06-30
Completion
2013-12-31

Countries

  • United States
  • Brazil
  • Canada
  • South Africa
  • Spain
  • Uganda

Study Locations

More Related Trials

Entities

Companies

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 NCT00694629 on ClinicalTrials.gov