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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Tuberculosis

Treatments: Drug: rifapentine (M000473); Drug: EFZ EMT TDF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01690403

INT12291

U1111-1131-1992 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

cohort 1

Experimental group

Description:

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

Treatment:

Drug: EFZ EMT TDF

Drug: rifapentine (M000473)

cohort 2

Experimental group

Description:

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

Treatment:

Drug: EFZ EMT TDF

Drug: rifapentine (M000473)

cohort 3 (optional)

Experimental group

Description:

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

Treatment:

Drug: EFZ EMT TDF

Drug: rifapentine (M000473)