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

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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)

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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