Antiretroviral Therapy and Extreme Weight | NCT01805427

Studies
Antiretroviral Therapy and Extreme Weight

NCT01805427

Sponsor

Hopital Lariboisière

Status

Completed

Last Update Posted

Dec 6, 2013Estimated

Enrollment

140Actual

Phase

Not provided

Conditions

HIV Infection

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EXTATIC	Other Identifier	URT

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Feb 28, 2013

First Submission Date that Met QC Criteria

Mar 5, 2013

First Posted Date

Mar 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2013

Last Update Posted Date

Dec 6, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephane Mouly, MD PhD, MD PhD, Hopital LariboisièrePrincipal Investigator

Lead Sponsor

Hopital LariboisièreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients treated with efavirenz		HIV-infected on stable HAART regimen with efavirenz
patients treated with atazanavir		HIV-infected patients on stable HAART regimen with atazanavir
patients treated with darunavir		HIV-infected patients on stable HAART regimen with darunavir

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
comparison of the trough concentrations between patients with Body Mass Index (BMI)<25 kg/m2 and patients with BMI >25 kg/m2		the day of enrollment

Secondary Outcomes

Measure	Description	Time Frame
comparison of the occurrence of virologic failure within each patient group		the day of enrollment

Other Outcomes

Measure	Description	Time Frame
occurrence of adverse events in each patient group		the day of enrollment

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

HIV-infected patients aged 18 years and older, treated with either efavirenz, atazanavir, or darunavir for at least 4 weeks and under stable treatment regimen

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Lariboisiere		Paris	Île-de-France Region	75010	France

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D001835	Body Weight

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

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Browse Branches

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