Interaction Study to Assess the Pharmacokinetic Interaction of Oral Administration of Rifapentine on ATRIPLA™ in HIV Patients
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/3/2014 |
| Start Date: | September 2012 |
| End Date: | March 2014 |
| Contact: | For site information, send an email with site number to |
| Email: | Contact-Us@sanofi-aventis.com |
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
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
- 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
- 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.
- 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.
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.
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