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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690403
• Other study ID #: INT12291
• Secondary ID: U1111-1131-1992
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2012
• Last updated: February 26, 2015
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: February 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Drug:
• rifapentine (M000473)
Pharmaceutical form:tablet Route of administration: oral
• EFZ EMT TDF
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
United States	Investigational Site Number 840001	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	To determine PK parameters Ctrough for rifapentine and 25-desacetyl- rifapentine (25-DR)		Cohort 2: Day 1, 8, and 15	No
Secondary	To determine PK parameters C8h for rifapentine and 25-desacetyl- rifapentine (25-DR)		Cohort 2: Day 1, 8, and 15	No