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

This study has been completed.

First Received on September 6, 2001. Last Updated on September 9, 2005 History of Changes

Sponsor:	Centers for Disease Control and Prevention
Collaborator:	Department of Veterans Affairs
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00023426

Purpose

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

Condition	Intervention	Phase
Tuberculosis	Drug: rifapentine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis

Drug Information available for: Rifapentine

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

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

Secondary Outcome Measures:

1. Rate of serious adverse events in each of the dosing groups
2. Rate of total adverse events in each of the groups
3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups

Estimated Enrollment:	150
Study Start Date:	July 1999
Estimated Study Completion Date:	February 2003

Detailed Description:

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.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023426

Show 23 Study Locations

Sponsors and Collaborators

Centers for Disease Control and Prevention

Department of Veterans Affairs

Investigators

Principal Investigator:

Naomi Bock, MD

Centers for Disease Control & Prevention

More Information

Additional Information:

(Click here for more information about the Tuberculosis Trials Consortium(TBTC) This link exits the ClinicalTrials.gov site

Publications:

Bock NN, Sterling TR, Hamilton CD, Pachucki C, Wang YC, Conwell DS, Mosher A, Samuels M, Vernon A; Tuberculosis Trials Consortium, Centers for Disease Control and Prevention, Atlanta, Georgia. A prospective, randomized, double-blind study of the tolerability of rifapentine 600, 900, and 1,200 mg plus isoniazid in the continuation phase of tuberculosis treatment. Am J Respir Crit Care Med. 2002 Jun 1;165(11):1526-30.

ClinicalTrials.gov Identifier:	NCT00023426 History of Changes
Other Study ID Numbers:	CDC-NCHSTP-2404, HCK45, 25
Study First Received:	September 6, 2001
Last Updated:	September 9, 2005
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:

tuberculosis
tb
rifapentine
safety
dose

Additional relevant MeSH terms:

Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Rifapentine
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Leprostatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012