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Randomized Clinical Trial of 4RIF Vs. 9INH for the Treatment of Latent TB
This study is currently recruiting participants.
Verified by McGill University, November 2004
Sponsored by: McGill University
Information provided by: McGill University
ClinicalTrials.gov Identifier: NCT00170209
  Purpose

Although effective medications to treat and even prevent Tuberculosis (TB) have been available for over 40 years, TB remains the most important infectious cause of mortality among adults in the world. One of the cornerstones of control of this disease is detection and treatment of infection – while it is still latent, or dormant. Nine months of Isoniazid (INH) is highly effective to treat latent infection, and so is considered the standard therapy. However, this therapy is often unsuccessful, because the long duration reduces completion rates, and increases cost, and it is associated with serious, even fatal side effects. An alternate regiment, of four months Rifampin has been recommended by authoritative agencies as an alternative, but there is surprisingly little data regarding the safety and efficacy of this regimen. We propose a randomized trial to compare the safety and costs of this regimen with the standard of 9 months INH, having completed a preliminary trial which demonstrated that the 4RIF regimen had significantly better completion rates. If the safety of 4RIF can be shown to be as as good, or better, than 9INH, then we will continue with a larger scale trial to compare the efficacy of the two regimens in preventing future active cases of TB among persons with latent TB infection


Condition Intervention Phase
Latent TB Infection
Drug: Isoniazide (drug), Rifampin (drug)
Phase IV

Drug Information available for: Rifampin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title: Randomized Controlled Trial of 4 Months Rifampin Versus 9 Months INH for the Treatment of Latent TB

Further study details as provided by McGill University:

Study Start Date: April 2004
Estimated Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Accept taking 9 months of Isoniazid for treatment of latent TB infection

Exclusion Criteria:

  • Less than 18 years old
  • contacts of INH resistant of index cases
  • HIV patients on triple therapy
  • drug interaction
  • inability to consent
  • women taking birth control pill and do not accept to take other forms of contraception
  • allergy to the study drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170209

Contacts
Contact: Dick Menzies, MD, MSc 514-934-1934 ext 32128 dick.menzies@mcgill.ca
Contact: Marie-Josée Dion, MSc 514-934-1934 ext 32162 marie-josee.dion@mail.mcgill.ca

Locations
Canada, Quebec
Montreal Chest Institute Recruiting
Montreal, Quebec, Canada, H2X 2P4
Contact: Marie-Josée Dion, MSc     514-934-1934 ext 32162     marie-josee.dion@mail.mcgill.ca    
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Dick Menzies, MD, MSc McGill University Health Center
  More Information

Study ID Numbers: MCT-44154
Study First Received: September 12, 2005
Last Updated: September 12, 2005
ClinicalTrials.gov Identifier: NCT00170209  
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Rifampin

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Antitubercular Agents
Infection
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Leprostatic Agents
Antibiotics, Antitubercular

ClinicalTrials.gov processed this record on January 16, 2009