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

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ClinicalTrials.gov Identifier: NCT01690403
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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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
Tuberculosis 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
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Study Type : Interventional  (Clinical Trial)
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 : December 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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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 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™


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. To determine PK parameters Ctrough for rifapentine and 25-desacetyl- rifapentine (25-DR) [ Time Frame: Cohort 2: Day 1, 8, and 15 ]
  5. To determine PK parameters C8h for rifapentine and 25-desacetyl- rifapentine (25-DR) [ Time Frame: Cohort 2: Day 1, 8, and 15 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01690403     History of Changes
Other Study ID Numbers: INT12291
U1111-1131-1992 ( Other Identifier: UTN )
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Tenofovir
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Rifapentine
Rifampin
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers