deltatrials
Completed OBSERVATIONAL NCT01805427

Antiretroviral Therapy and Extreme Weight (EXTATIC)

Extreme Weights and Antiretroviral Therapy Individual Concentrations

Sponsor: Hopital Lariboisière

Conditions HIV Infection
Updated 7 times since 2017 Last updated: Dec 5, 2013 Started: Sep 30, 2012 Primary completion: Nov 30, 2013 Completion: Nov 30, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates HIV Infection and is currently completed. Hopital Lariboisière leads this study, which shows 7 recorded versions since 2012 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed

  2. Sep 2024 — Present [monthly]

    Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Completed

  4. Jan 2021 — Jul 2024 [monthly]

    Completed

  5. Jun 2018 — Jan 2021 [monthly]

    Completed

Show 2 earlier versions
  1. Apr 2018 — Jun 2018 [monthly]

    Completed

    Phase: NANone

  2. Jan 2017 — Apr 2018 [monthly]

    Completed NA

    First recorded

Sep 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hopital Lariboisière
Data source: Hopital Lariboisière

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations