High Dose Rifapentine Pharmacokinetics, Tolerability and Safety Dosage Rifapentine for Treatment of Tuberculosis (TBTC-29PK)

August 15, 2012 updated by: Centers for Disease Control and Prevention

Pharmacokinetic and Pharmacodynamic Studies of Efficacy, Tolerability and Safety of Higher Dosage Rifapentine for Treatment of Tuberculosis

The primary objective of this study is to characterize rifapentine drug levels in patients with TB in relationship to its effectiveness in treating TB and any adverse effects experienced by participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a one-period, non-blinded, multi-center pharmacokinetic substudy of rifapentine and rifampin in patients with tuberculosis enrolled in Tuberculosis Trials Consortium (TBTC) Study 29. This PK substudy will use a convenience sample, i.e. be restricted to TBTC sites having logistical capacity for intensive pharmacokinetic sampling. These sites will have non-random selection of patients. In addition to the intensive sampling of 60 patients in this PK study, all patients receiving rifapentine in Study 29 will be eligible for sparse PK sampling as part of the parent treatment protocol.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Durban, South Africa
        • University of KwaZulu Natal
  • Uganda
      • Kampala, Uganda
        • Uganda / Case Western Reserve Research Collaboration
  • United States
    • Colorado
      • Denver, Colorado, United States
        • Denver public Health
    • Texas
      • Denton, Texas, United States
        • University of North Texas
      • Harlingen, Texas, United States
        • TBTC site 40 / South Texas
      • San Antonio, Texas, United States
        • Audie L. Murphy VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient enrolled in TBTC Study 29.
  • Provision of informed consent for the study.
  • Willingness to be sampled in an out-patient clinic or be admitted to a General Clinical Research Center (GCRC) or hospital on one occasion

Exclusion Criteria:

• Severe anemia as defined by a hematocrit less than 25% (most recent value, measured within 30 days of the PK study).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Rifapentine
Drug: Rifapentine
During the first 8 weeks of therapy for TB participants > 45 kg will receive rifapentine 600 mg orally given 5 per week and for participants < 45 kg participants will receive 450 mg orally given 5 days per week
Other Names:
  • Priftin
Active Comparator: 2
Rifampin
Drug: Rifampin
During the first 8 weeks of therapy participants will receive rifampin at standard doses (e.g. 600 mg) 5 days per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this study is to characterize rifapentine pharmacokinetic parameters (AUC0-24 and peak concentration) in patients with TB.
Time Frame: on or after the 10th day from the start of Study 29 therapy
on or after the 10th day from the start of Study 29 therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
• To assess the pharmacodynamic effects of higher dose, daily rifapentine AUC0-24 on tolerability and safety during two months of treatment of tuberculosis.
Time Frame: on or after the 10th day of study therapy
on or after the 10th day of study therapy
• To assess the pharmacodynamic effect of rifapentine pharmacokinetic parameters (AUC0-24) on biomarkers of treatment activity in patients with tuberculosis.
Time Frame: on or after the 10th day of study therapy
on or after the 10th day of study therapy
• To assess in multivariate analyses the pharmacodynamic effect on biomarkers of treatment activity of the independent variables of rifapentine AUC0-24, HIV infection, isoniazid exposure (AUC0-12) and study site (African vs. non-African).
Time Frame: on or after the 10th day of study therapy
on or after the 10th day of study therapy
To determine if free (non-protein bound) rifapentine and free rifampin exposures are directly associated with anti-mycobacterial activity.
Time Frame: on or after the 10th day of study therapy
on or after the 10th day of study therapy
• To determine the effects of polymorphisms of transporter genes on rifampin and rifapentine pharmacokinetic parameters.
Time Frame: on or after the 10th day of therapy
on or after the 10th day of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Marc Weiner, MD, University of Texas Health Sciences Campus, San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

January 6, 2010

First Posted (Estimate)

January 7, 2010

Study Record Updates

Last Update Posted (Estimate)

August 17, 2012

Last Update Submitted That Met QC Criteria

August 15, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBTC Study 29PK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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