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

Phase 1

Completed

• Conditions: Tuberculosis
• Interventions: Drug: rifapentine (M000473); Drug: EFZ EMT TDF

• Registration Number: NCT01690403
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

* 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.

Study Timeline

• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-21
• Study Start: 2012-12
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-26
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cohort 2	EFZ EMT TDF	Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 2).
cohort 2	rifapentine (M000473)	Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 2).
cohort 1	EFZ EMT TDF	Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 1).
cohort 3 (optional)	rifapentine (M000473)	Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 3).
cohort 1	rifapentine (M000473)	Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 1).
cohort 3 (optional)	EFZ EMT TDF	Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 3).

Primary Outcome Measures

Name	Time	Method
To determine PK parameters Cmax, Cmin and AUC0-24 for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)	Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2 ,Day 1 and Day 16 for cohort 2

Secondary Outcome Measures

Name	Time	Method
To determine PK parameters Ctrough for rifapentine and 25-desacetyl- rifapentine (25-DR)	Cohort 2: Day 1, 8, and 15
To determine PK parameters tlag, CL/F for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)	Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2, Day 1 and Day 16 for cohort 2
To determine PK parameters t1/2z, tmax for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)	Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2, Day 1 and Day 16 for cohort 2
To determine PK parameter for AUC0-10 for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF)	Day -2 and Day 1 for cohorts 1 and 3
To determine PK parameters C8h for rifapentine and 25-desacetyl- rifapentine (25-DR)	Cohort 2: Day 1, 8, and 15

Trial Locations

Locations (1)

Investigational Site Number 840001; 🇺🇸 Buffalo, New York, United States