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
  Purpose

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 Intervention Phase
Tuberculosis
Drug: rifapentine (M000473)
Drug: EFZ EMT TDF
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: September 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: ATRIPLA™

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.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690403

Locations
United States, New York
Investigational Site Number 840001
Buffalo, New York, United States, 14202
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01690403     History of Changes
Other Study ID Numbers: INT12291, U1111-1131-1992
Study First Received: September 13, 2012
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Rifapentine
Rifampin
Tenofovir disoproxil
Tenofovir
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Leprostatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 22, 2014