Antiretroviral Therapy and Extreme Weight

HIV Infection Clinical Trial

— EXTATIC  

Official title:

Extreme Weights and Antiretroviral Therapy Individual Concentrations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805427
• Other study ID #: EXTATIC
• Secondary ID: EXTATIC
• Status: Completed
• Phase: N/A
• First received: February 28, 2013
• Last updated: December 5, 2013
• Start date: September 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Hopital Lariboisière
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infection

Locations

Country	Name	City	State
France	Hopital Lariboisiere	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Lariboisière

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	occurrence of adverse events in each patient group		the day of enrollment	Yes
Primary	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	No
Secondary	comparison of the occurrence of virologic failure within each patient group		the day of enrollment	No