Interaction Study to Assess the Pharmacokinetic Interaction of Oral Administration of Rifapentine on ATRIPLA™ in HIV Patients

Overview

Primary Objective: \- To evaluate the effect of single and repeated administration of rifapentine given as daily or weekly regimen on steady-state pharmacokinetic parameters of efavirenz, emtricitabine and tenofovir given as a fixed dose combination (ATRIPLA™ ). Secondary Objective: \- To evaluate the safety and tolerability of concomitant administration of rifapentine and ATRIPLA™ given to HIV+ patients

* Screening to admission: up to 21 days * Admission to the end of the follow-up: up to 41 days * Period 1: Treatment period of 15 days with ATRIPLA™ (background therapy). Patients should receive the same regimen and dose of ATRIPLA™ during the all study screening and period 1. * Period 2: Treatment over a period of 21 days in co-administration with rifapentine. * Follow up: 3 to 5 days after the last rifapentine administration.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes