Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
140 participants
OBSERVATIONAL
2012-09-30
2013-11-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients treated with efavirenz
HIV-infected on stable HAART regimen with efavirenz
No interventions assigned to this group
patients treated with atazanavir
HIV-infected patients on stable HAART regimen with atazanavir
No interventions assigned to this group
patients treated with darunavir
HIV-infected patients on stable HAART regimen with darunavir
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Hopital Lariboisière
OTHER
Responsible Party
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Stephane Mouly, MD PhD
MD PhD
Locations
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Hopital Lariboisiere
Paris, Île-de-France Region, France
Countries
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Other Identifiers
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EXTATIC
Identifier Type: OTHER
Identifier Source: secondary_id
EXTATIC
Identifier Type: -
Identifier Source: org_study_id