The Effect of Rifapentine on Raltegravir

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00809718
First received: December 15, 2008
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

The aim of this study is to study the effect of rifapentine on plasma concentrations of raltegravir.


Condition Intervention Phase
Healthy
Drug: Raltegravir and rifapentine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: The Effect of Rifapentine on Plasma Concentrations of Raltegravir

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Raltegravir pharmacokinetics (Cmin and AUC) [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability and safety of concomitant raltegravir and rifapentine administration [ Time Frame: Eight weeks ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: February 2009
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
raltegravir and rifapentine
Concomitant administration of raltegravir and rifapentine in healthy volunteers
Drug: Raltegravir and rifapentine

Period 1- Raltegravir 400 mg q12h by mouth for 4 days

Period 2- Rifapentine 900 mg taken by mouth once per week for 3 doses and raltegravir 400 mg q12h by mouth for 4 days

Period 3- Rifapentine 600 mg taken by mouth once daily for 5 of 7 days per week for 10 doses and raltegravir 400 mg q12h by mouth for 4 days

Other Names:
  • Isentress - Raltegravir
  • Priftin - Rifapentine

Detailed Description:

Primary Objective

To compare the pharmacokinetics parameter values (geometric mean Cmin and AUC) of raltegravir at 400 mg q12h alone to raltegravir at 400 mg q12h co-administered in combination with rifapentine 900 mg once weekly, and to raltegravir at 400 mg q12h co-administered in combination with rifapentine 600 mg per day, 5 days per week.

Secondary Objective

To assess the tolerability and safety of concomitant administration of raltegravir and rifapentine in healthy volunteers.

Design

This study is a three-period, one-sequence, open label, pharmacokinetic study of the raltegravir-rifapentine interactions in healthy, male and female volunteers. Up to 21 subjects may be enrolled to achieve the estimated sample size of 16 completing subjects. All study medication will be self-administered except on the days of pharmacokinetic sampling. All subjects will participate in three sampling periods and be studied in a day clinic or be admitted overnight to a hospital.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or non-pregnant, non-nursing female age > 18 years in good health
  • Provision of informed consent for the study.
  • HIV-uninfected. A prior negative HIV test (ELISA) must be obtained before enrollment.
  • Willingness to have PK sampling in a day clinic or to be admitted overnight to a hospital on three occasions.
  • Women of child-bearing potential must agree to practice an adequate method of birth control during the study and for 30 days after the last dose of study medication. Barrier methods of contraception or abstinence from sexual activity are satisfactory methods of birth control.
  • Karnofsky score ≥ 90.
  • Laboratory screening before enrollment:

    • Hematocrit > 30 percent (most recent value)
    • AST < 2 times the upper limit of normal
    • ALT < 2 times the upper limit of normal
    • Bilirubin < 2 times the upper limit of normal
    • Creatinine < 1.5 times the upper limit of normal
    • Negative urine drug screen

Exclusion Criteria:

  • Pregnancy or breast-feeding.
  • Use of a medication or food that has the potential to alter the concentrations of raltegravir or rifapentine, within the 14 days prior to or during the periods of pharmacokinetic monitoring.
  • Known intolerance to raltegravir or rifamycin antibiotics or prior use in the last 30 days.
  • Weight less than 46 kg or greater than 102 kg.
  • Prior gastrointestinal surgery.
  • Infection with Hepatitis B or Hepatitis C by serologies.
  • Co-morbidity for which concomitant, current medications are taken regularly. If concomitant medications are taken intermittently, these medications should not have potential to alter the concentrations of raltegravir or rifapentine.
  • Current imprisonment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809718

Locations
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Audie L Murphy Veterans Administration Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Marc Weiner, M.D. The University of Texas Health Science Center at San Antonio
  More Information

No publications provided by The University of Texas Health Science Center at San Antonio

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00809718     History of Changes
Other Study ID Numbers: TBTC 29RR
Study First Received: December 15, 2008
Last Updated: September 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Raltegravir
Pharmacokinetics
Rifapentine
Drug Kinetics

Additional relevant MeSH terms:
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 October 19, 2014