Antiretroviral Therapy and Extreme Weight (EXTATIC)

Hopital Lariboisière

Status: Completed

Conditions: HIV Infection

Study type: Observational

Funder types: Other

Identifiers

NCT01805427

EXTATIC (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

140 participants in 3 patient groups

patients treated with efavirenz

Description:

HIV-infected on stable HAART regimen with efavirenz

patients treated with atazanavir

Description:

HIV-infected patients on stable HAART regimen with atazanavir

patients treated with darunavir

Description:

HIV-infected patients on stable HAART regimen with darunavir