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

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Rifapentine Atripla

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

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:	December 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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:	February 26, 2015
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 23, 2016