Antiretroviral Therapy and Extreme Weight (EXTATIC)
|ClinicalTrials.gov Identifier: NCT01805427|
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : December 6, 2013
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||140 participants|
|Official Title:||Extreme Weights and Antiretroviral Therapy Individual Concentrations|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
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
- 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 ]
- comparison of the occurrence of virologic failure within each patient group [ Time Frame: the day of enrollment ]
- occurrence of adverse events in each patient group [ Time Frame: the day of enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805427
|Paris, Ile-de-France, France, 75010|