Clinical trial NCT01805427: Antiretroviral Therapy and Extreme Weight
Official title: Extreme Weights and Antiretroviral Therapy Individual Concentrations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: trough concentration
weight
HIV
virological failure
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: comparison of the trough concentrations between patients with Body Mass Index (BMI)<25 kg/m2 and patients with BMI >25 kg/m2
timeFrame: the day of enrollment
Secondary outcomes:
measure: comparison of the occurrence of virologic failure within each patient group
timeFrame: the day of enrollment
Other outcomes:
measure: occurrence of adverse events in each patient group
timeFrame: the day of enrollment
Locations:
city: Paris
country: France
facility: Hopital Lariboisiere
state: Ile-de-France
Study officials:
References: