HIV Infection
Conditions
Keywords
trough concentration, weight, HIV, virological failure
Brief summary
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.
Detailed description
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 Secondary endpoints: * 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. Sample size: 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.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with HIV+ receiving one of the following third agent their HAART: efavirenz, atazanavir , or darunavir * Patients aged \> 18 years old. * Patient giving its well-informed and free consent. Patient giving its well-informed and free consent. Patients living in France during the study.
Exclusion criteria
Treatment with rifampin/rifabutin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| comparison of the trough concentrations between patients with Body Mass Index (BMI)<25 kg/m2 and patients with BMI >25 kg/m2 | the day of enrollment |
Secondary
| Measure | Time frame |
|---|---|
| comparison of the occurrence of virologic failure within each patient group | the day of enrollment |
Other
| Measure | Time frame |
|---|---|
| occurrence of adverse events in each patient group | the day of enrollment |
Countries
France