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

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT01690403
Collaborator
(none)
25
Enrollment
1
Location
3
Arms
14.9
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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
Condition or Disease Intervention/Treatment Phase
  • Drug: rifapentine (M000473)
  • Drug: EFZ EMT TDF
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
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
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: cohort 1

Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 1).

Drug: rifapentine (M000473)
Pharmaceutical form:tablet Route of administration: oral

Drug: EFZ EMT TDF
Pharmaceutical form:tablet Route of administration: oral
Other Names:
  • ATRIPLA™

    		•
    Experimental: cohort 2

    Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 2).

    Drug: rifapentine (M000473)
    Pharmaceutical form:tablet Route of administration: oral

    Drug: EFZ EMT TDF
    Pharmaceutical form:tablet Route of administration: oral
    Other Names:
  • ATRIPLA™

    		•
    Experimental: cohort 3 (optional)

    Period 1 (15 days) : ATRIPLA™ Period 2 (21 days) : ATRIPLA™ + oral rifapentine (regimen 3).

    Drug: rifapentine (M000473)
    Pharmaceutical form:tablet Route of administration: oral

    Drug: EFZ EMT TDF
    Pharmaceutical form:tablet Route of administration: oral
    Other Names:
  • ATRIPLA™

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    2. 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]

    3. 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]

    4. To determine PK parameters Ctrough for rifapentine and 25-desacetyl- rifapentine (25-DR) [Cohort 2: Day 1, 8, and 15]

    5. To determine PK parameters C8h for rifapentine and 25-desacetyl- rifapentine (25-DR) [Cohort 2: Day 1, 8, and 15]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number 840001 Buffalo New York United States 14202

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT01690403
    Other Study ID Numbers:
    • INT12291
    • U1111-1131-1992
    First Posted:
    Sep 21, 2012
    Last Update Posted:
    Feb 27, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:
    Tuberculosis
    Rifapentine

    Study Results

    No Results Posted as of Feb 27, 2015