HIV Infection Clinical Trial
Official title:
Extreme Weights and Antiretroviral Therapy Individual Concentrations
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
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