Antiretroviral Therapy and Extreme Weight (EXTATIC)
Extreme Weights and Antiretroviral Therapy Individual Concentrations
Sponsor: Hopital Lariboisière
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
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed
-
Sep 2024 — Present [monthly]
Completed
-
Jul 2024 — Sep 2024 [monthly]
Completed
-
Jan 2021 — Jul 2024 [monthly]
Completed
-
Jun 2018 — Jan 2021 [monthly]
Completed
▶ Show 2 earlier versions
-
Apr 2018 — Jun 2018 [monthly]
Completed
Phase: NA → None
-
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
- Hopital Lariboisière
For direct contact, visit the study record on ClinicalTrials.gov .