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Completed

NCT Number: NCT01805427

Antiretroviral Therapy and Extreme Weight

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Body Weight Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Urogenital Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Lariboisiere

Paris, Île-de-France Region, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. comparison of the occurrence of virologic failure within each patient group

    Time frame: the day of enrollment

Other outcomes

  1. occurrence of adverse events in each patient group

    Time frame: the day of enrollment

Sponsors and collaborators

Lead sponsor

Hopital Lariboisière

Other

Registry information

Official study title

Extreme Weights and Antiretroviral Therapy Individual Concentrations

Acronym: EXTATIC

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 6, 2013
Registry last updated
Dec 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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