Antiretroviral Therapy and Extreme Weight

Study Overview
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Brief Summary
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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
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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.

Official Title
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Extreme Weights and Antiretroviral Therapy Individual Concentrations

Conditions
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HIV Infection

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients treated with efavirenz<br>HIV-infected on stable HAART regimen with efavirenz | |
| patients treated with atazanavir<br>HIV-infected patients on stable HAART regimen with atazanavir | |
| patients treated with darunavir<br>HIV-infected patients on stable HAART regimen with darunavir | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of the occurrence of virologic failure within each patient group |  | the day of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, trough concentration, weight, virological failure