NCT01690403

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

September 13, 2012

Last Update Submit

February 26, 2015

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (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 Outcomes (5)

  • 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

Study Arms (3)

cohort 1

EXPERIMENTAL

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

Drug: rifapentine (M000473)Drug: EFZ EMT TDF

cohort 2

EXPERIMENTAL

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

Drug: rifapentine (M000473)Drug: EFZ EMT TDF

cohort 3 (optional)

EXPERIMENTAL

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

Drug: rifapentine (M000473)Drug: EFZ EMT TDF

Interventions

rifapentine (M000473)DRUG

Pharmaceutical form:tablet Route of administration: oral

cohort 1cohort 2cohort 3 (optional)
EFZ EMT TDFDRUG

Pharmaceutical form:tablet Route of administration: oral

Also known as: ATRIPLA™
cohort 1cohort 2cohort 3 (optional)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- HIV+ male and female patients receiving ATRIPLA™ aged 18 to 55 years old with a CD4 count cells of at least 350

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site Number 840001

Buffalo, New York, 14202, United States

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

rifapentineEfavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TenofovirOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEmtricitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDrug CombinationsPharmaceutical Preparations

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 21, 2012

Study Start

December 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

February 27, 2015

Record last verified: 2015-02

Locations

US(1)