NCT01805427

Antiretroviral Therapy and Extreme Weight

Extreme Weights and Antiretroviral Therapy Individual Concentrations

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Hopital Lariboisière · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infection

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-03-06
• Last updated: 2013-12-06

Locations

1 site across 1 country: France