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Antiretroviral Therapy and Extreme Weight

Extreme Weights and Antiretroviral Therapy Individual Concentrations

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01805427
Acronym
EXTATIC
Enrollment
140
Registered
2013-03-06
Start date
2012-09-30
Completion date
2013-11-30
Last updated
2013-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

trough concentration, weight, HIV, virological failure

Brief summary

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.

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.

Interventions

None listed

Sponsors

Hopital Lariboisière
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
comparison of the trough concentrations between patients with Body Mass Index (BMI)<25 kg/m2 and patients with BMI >25 kg/m2the day of enrollment

Secondary

MeasureTime frame
comparison of the occurrence of virologic failure within each patient groupthe day of enrollment

Other

MeasureTime frame
occurrence of adverse events in each patient groupthe day of enrollment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026