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

This study is currently recruiting participants.

Verified June 2013 by Sanofi

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT01690403

First received: September 13, 2012

Last updated: June 10, 2013

Last verified: June 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2012

Last Updated Date

June 10, 2013

Start Date ^ICMJE

September 2012

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine PK parameters Cmax, Cmin and AUC0-24 for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF) [ Time Frame: Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2 ,Day 1 and Day 16 for cohort 2 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To determine PK parameters Cmax, Cmin and AUC0-24 for efavirenz, emtricitabine and tenofovir [ Time Frame: Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2 ,Day 1 and Day 16 for cohort 2 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01690403 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine PK parameters t1/2z, tmax for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF) [ Time Frame: Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2, Day 1 and Day 16 for cohort 2 ] [ Designated as safety issue: No ]
To determine PK parameters tlag, CL/F for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF) [ Time Frame: Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2, Day 1 and Day 16 for cohort 2 ] [ Designated as safety issue: No ]
To determine PK parameter for AUC0-10 for efavirenz (EFZ), emtricitabine (EMT) and tenofovir (TDF) [ Time Frame: Day -2 and Day 1 for cohorts 1 and 3 ] [ Designated as safety issue: No ]
To determine PK parameters Ctrough for rifapentine and 25-desacetyl- rifapentine (25-DR) [ Time Frame: Cohort 2: Day 1, 8, and 15 ] [ Designated as safety issue: No ]
To determine PK parameters C8h for rifapentine and 25-desacetyl- rifapentine (25-DR) [ Time Frame: Cohort 2: Day 1, 8, and 15 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To determine PK parameters t1/2z, tmax for efavirenz, emtricitabine and tenofovir [ Time Frame: Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2, Day 1 and Day 16 for cohort 2 ] [ Designated as safety issue: No ]
To determine PK parameters tlag, CL/F for efavirenz, emtricitabine and tenofovir [ Time Frame: Day-2, Day 1 and Day 21 for cohorts 1 and 3, and on Day -2, Day 1 and Day 16 for cohort 2 ] [ Designated as safety issue: No ]
To determine PK parameter for AUC0-10 for efavirenz, emtricitabine and tenofovir [ Time Frame: Day -2 and Day 1 for cohorts 1 and 3 ] [ Designated as safety issue: No ]
To determine PK parameters Ctrough for rifapentine and 25-desacetyl- rifapentine (25-DR) [ Time Frame: Cohort 2: Day 1, 8, and 15 ] [ Designated as safety issue: No ]
To determine PK parameters C8h for rifapentine and 25-desacetyl- rifapentine (25-DR) [ Time Frame: Cohort 2: Day 1, 8, and 15] ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-label, Non-randomized, Single Sequence, Two Periods, Four-treatment, Three Parallel Groups Pharmacokinetic Interaction Study of Repeated Oral Doses (Daily or Weekly Regimen) of Rifapentine on ATRIPLA™ (Fixed Dose Combination of Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate) Given to HIV+ Patients

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Tuberculosis

Intervention ^ICMJE

Drug: rifapentine (M000473)
Pharmaceutical form:tablet

Route of administration: oral
Drug: EFZ EMT TDF
Pharmaceutical form:tablet

Route of administration: oral

Other Name: ATRIPLA™

Study Arm (s)

Experimental: cohort 1
Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 1).
Interventions:
- Drug: rifapentine (M000473)
- Drug: EFZ EMT TDF
Experimental: cohort 2
Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 2).
Interventions:
- Drug: rifapentine (M000473)
- Drug: EFZ EMT TDF
Experimental: cohort 3 (optional)
Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 3).
Interventions:
- Drug: rifapentine (M000473)
- Drug: EFZ EMT TDF

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria :

- HIV+ male and female patients receiving ATRIPLA™ aged 18 to 55 years old with a CD4 count cells of at least 350

Exclusion criteria:

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological (patients with porphyria), neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness other than HIV disease.
Active or latent tuberculosis infection

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: For site information, send an email with site number to

Contact-Us@sanofi-aventis.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01690403

Other Study ID Numbers ^ICMJE

INT12291, U1111-1131-1992

Has Data Monitoring Committee

Responsible Party

Sanofi

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Sciences & Operations

Sanofi

Information Provided By

Sanofi

Verification Date

June 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top