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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01690403

Enrollment

Registered

2012-09-21

Start date

2012-12-31

Completion date

2014-03-31

Last updated

2015-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

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

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.

Interventions

DRUGrifapentine (M000473)

Pharmaceutical form:tablet Route of administration: oral

DRUGEFZ EMT TDF

Pharmaceutical form:tablet Route of administration: oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
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
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
To determine PK parameters Ctrough for rifapentine and 25-desacetyl- rifapentine (25-DR)	Cohort 2: Day 1, 8, and 15
To determine PK parameters C8h for rifapentine and 25-desacetyl- rifapentine (25-DR)	Cohort 2: Day 1, 8, and 15

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026