NCT00809718

The Effect of Rifapentine on Raltegravir

The Effect of Rifapentine on Plasma Concentrations of Raltegravir

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-05-01
• Completion: 2011-08-01
• First posted: 2008-12-17
• Last updated: 2015-10-22

Locations

2 sites across 1 country: United States