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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01690403
First received: September 13, 2012
Last updated: March 24, 2014
Last verified: March 2014

September 13, 2012
March 24, 2014
September 2012
March 2014   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01690403 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Interaction Study to Assess the Pharmacokinetic Interaction of Oral Administration of Rifapentine on ATRIPLA™ in HIV Patients
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

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Tuberculosis
  • Drug: rifapentine (M000473)

    Pharmaceutical form:tablet

    Route of administration: oral

  • Drug: EFZ EMT TDF

    Pharmaceutical form:tablet

    Route of administration: oral

    Other Name: ATRIPLA™
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2014
March 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01690403
INT12291, U1111-1131-1992
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
March 2014

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