Antiretroviral Therapy and Extreme Weight (EXTATIC)
The concentration of the third agent in antiretroviral therapy [Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI), or boosted Protease inhibitor (PI) ] is different according to the body weight or body composition and therapeutic monitoring may be necessary in overweight HIV patients.
The investigators aim at measuring the individual trough concentrations of interest [at steady state for NNRTI and boosted PI] in overweight and normal weight HIV+ patients.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Extreme Weights and Antiretroviral Therapy Individual Concentrations|
- comparison of the trough concentrations between patients with Body Mass Index (BMI)<25 kg/m2 and patients with BMI >25 kg/m2 [ Time Frame: the day of enrollment ] [ Designated as safety issue: No ]
- comparison of the occurrence of virologic failure within each patient group [ Time Frame: the day of enrollment ] [ Designated as safety issue: No ]
- occurrence of adverse events in each patient group [ Time Frame: the day of enrollment ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
patients treated with efavirenz
HIV-infected on stable HAART regimen with efavirenz
patients treated with atazanavir
HIV-infected patients on stable HAART regimen with atazanavir
patients treated with darunavir
HIV-infected patients on stable HAART regimen with darunavir
Our primary endpoint is the individual trough concentrations of interest at steady state for NNRTI or boosted PI; Principal outcome measure: comparison of the concentrations between patients <25kg/m2 and patients<25kg/m2
- Occurrence of virologic failure
- Occurrence of clinical/biological adverse events
- Percentage of patients with concentration within the therapeutic range
- Body composition Secondary outcome measures: comparison of the occurrence of virologic failure, occurrence or adverse event, patients with concentration within the therapeutic range between groups. Correlation between body composition and concentration.
Methodology, study design:
open-labelled monocentric study.
It will be a descriptive experimental study involving 120 overweight subjects, 120 normal weight subjects
Inclusion criteria :
- Patients with HIV+
- Patients aged more than 18 years old.
- Patient giving its well-informed and free consent.
Study design :
Plasma concentration was performed during the usual clinical follow-up. Study duration: 12 months Duration for a patient: 1 day Investigating center and participating units: one center enrolling the patients and the lab performing drug dosages.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01805427
|Paris, Ile-de-France, France, 75010|