An observational study in HIV Infection, sponsored by Hopital Lariboisière. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-12-06.
Sponsored by Hopital Lariboisière · Observational
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:
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 :
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 140 is below the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →Hopital Lariboisière is the lead sponsor of 29 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
HIV-infected patients aged 18 years and older, treated with either efavirenz, atazanavir, or darunavir for at least 4 weeks and under stable treatment regimen
Patients living in France during the study.
Exclusion Criteria:
Treatment with rifampin/rifabutin
HIV-infected on stable HAART regimen with efavirenz
HIV-infected patients on stable HAART regimen with atazanavir
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
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Hopital Lariboisière