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Antiretroviral Therapy and Extreme Weight (EXTATIC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephane Mouly, MD PhD, Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT01805427
First received: February 28, 2013
Last updated: December 5, 2013
Last verified: December 2013

February 28, 2013
December 5, 2013
September 2012
November 2013   (final data collection date for primary outcome measure)
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 ]
comparison of the trough concentrations between patients with BMI<25 kg/m2 and patients with BMI >25 kg/m2 [ Time Frame: the day of enrollment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01805427 on ClinicalTrials.gov Archive Site
comparison of the occurrence of virologic failure within each patient group [ Time Frame: the day of enrollment ] [ Designated as safety issue: No ]
Same as current
occurrence of adverse events in each patient group [ Time Frame: the day of enrollment ] [ Designated as safety issue: Yes ]
Same as current
 
Antiretroviral Therapy and Extreme Weight
Extreme Weights and Antiretroviral Therapy Individual Concentrations

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

HIV Infection
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
November 2013
November 2013   (final data collection date for primary outcome measure)

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

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01805427
EXTATIC, EXTATIC
No
Stephane Mouly, MD PhD, Hopital Lariboisière
Hopital Lariboisière
Not Provided
Not Provided
Hopital Lariboisière
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP