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NCT Number: NCT00023426

TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis

Randomized, double-blind study of the tolerability of three different doses of rifapentine

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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About this study

Prospective, randomized, double-blinded, comparative study. Patients are randomized at the completion of induction phase therapy. Sample-size is 50 HIV-seronegative patients with culture-positive, drug susceptible TB in each treatment arm. The first 75 patients will be randomized 2:1 to 900 mg:600 mg rifapentine. The second 75 patients will be randomized 2:1 to 1200 mg:600 mg rifapentine. The DSMB will review tolerability and safety data on the first 21 patients enrolled (at the 900 mg and 600 mg doses) and approve proceeding to enrollment at the 1200 mg dose.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusions:

  • Drug susceptible culture-positive tuberculosis
  • Adequate induction therapy
  • Age >18
  • Normal screening labs
  • Karnofsky >=60
  • Informed consent
  • Birth control if of child bearing potential

Exclusions:

  • SilicoTB
  • Skeletal or CNS TB
  • Pregnant or breastfeeding
  • Intolerance to INH or rifamycins
  • Over 70 days TB treatment just prior to enrollment

Treatment and study plan

rifapentine

Drug

Primary outcomes

  1. Proportion of patients who fail to complete therapy in each of the dosing groups

Secondary outcomes

  1. 1. Rate of serious adverse events in each of the dosing groups

  2. 2. Rate of total adverse events in each of the groups

  3. 3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine

Important dates

Study start
1999
Study completion
2003
First posted
Sep 10, 2001
Registry last updated
Sep 13, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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