Antiretroviral Therapy and Extreme Weight

Completed

• Conditions: HIV Infection

• Registration Number: NCT01805427
• Lead Sponsor: Hopital Lariboisière

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-06
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
comparison of the occurrence of virologic failure within each patient group	the day of enrollment

Trial Locations

Locations (1)

Hopital Lariboisiere; 🇫🇷 Paris, Ile-de-France, France