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Antiretroviral Therapy and Extreme Weight (EXTATIC)

This study is currently recruiting participants.
Verified March 2013 by Hopital Lariboisière
Sponsor:
Information provided by (Responsible Party):
Stephane Mouly, MD PhD, Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT01805427
First received: February 28, 2013
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition
HIV Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Extreme Weights and Antiretroviral Therapy Individual Concentrations

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Hopital Lariboisière:

Primary Outcome Measures:
  • comparison of the trough concentrations between patients with Body Mass Index (BMI)<25 kg/m2 and patients with BMI >25 kg/m2 [ Time Frame: the day of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • comparison of the occurrence of virologic failure within each patient group [ Time Frame: the day of enrollment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • occurrence of adverse events in each patient group [ Time Frame: the day of enrollment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 135
Study Start Date: September 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients treated with efavirenz
HIV-infected on stable HAART regimen with efavirenz
patients treated with atazanavir
HIV-infected patients on stable HAART regimen with atazanavir
patients treated with darunavir
HIV-infected patients on stable HAART regimen with darunavir

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01805427

Contacts
Contact: Pierre O Sellier, MD PhD 0149959024 pierre.sellier@lrb.aphp.fr
Contact: celia lloret-linares, MD 0149958306 celia.lloret-linares@lrb.aphp.fr

Locations
France
Hopital Lariboisiere Recruiting
Paris, Ile-de-France, France, 75010
Principal Investigator: Pierre O Sellier, MD PhD            
Sponsors and Collaborators
Hopital Lariboisière
  More Information

No publications provided

Responsible Party: Stephane Mouly, MD PhD, MD PhD, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT01805427     History of Changes
Other Study ID Numbers: EXTATIC, EXTATIC
Study First Received: February 28, 2013
Last Updated: March 11, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hopital Lariboisière:
trough concentration
weight
HIV
virological failure

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on June 18, 2013