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

NCT ID: NCT01690403

Last Updated: 2015-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-03-31

Brief Summary

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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

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* 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.

Conditions

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Tuberculosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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cohort 1

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

Group Type EXPERIMENTAL

rifapentine (M000473)

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

EFZ EMT TDF

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

cohort 2

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

Group Type EXPERIMENTAL

rifapentine (M000473)

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

EFZ EMT TDF

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

cohort 3 (optional)

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

Group Type EXPERIMENTAL

rifapentine (M000473)

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

EFZ EMT TDF

Intervention Type DRUG

Pharmaceutical form:tablet

Route of administration: oral

Interventions

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rifapentine (M000473)

Pharmaceutical form:tablet

Route of administration: oral

Intervention Type DRUG

EFZ EMT TDF

Pharmaceutical form:tablet

Route of administration: oral

Intervention Type DRUG

Other Intervention Names

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ATRIPLA™

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 840001

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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U1111-1131-1992

Identifier Type: OTHER

Identifier Source: secondary_id

INT12291

Identifier Type: -

Identifier Source: org_study_id