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The Effect of Rifapentine on Raltegravir

Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Raltegravir and rifapentine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: The University of Texas Health Science Center at San Antonio

Official(s) and/or principal investigator(s):
Marc Weiner, M.D., Principal Investigator, Affiliation: The University of Texas Health Science Center at San Antonio

Summary

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

Clinical Details

Official title: The Effect of Rifapentine on Plasma Concentrations of Raltegravir

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Raltegravir pharmacokinetics (Cmin and AUC)

Secondary outcome: Tolerability and safety of concomitant raltegravir and rifapentine administration

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Audie L Murphy Veterans Administration Hospital, San Antonio, Texas 78229, United States

University of Texas Health Science Center, San Antonio, Texas 78229, United States

Additional Information

Starting date: February 2009
Last updated: September 10, 2012

Page last updated: August 23, 2015

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