PREFACE - Study on the prevalence of facial lipoatrophy in patients infected by HIV virus receiving antiretroviral drugs - FRAN08-005 ARCHIVE

Head :
Cohen-Codar Isabelle

Last update : 07/01/2019 | Version : 3 | ID : 115

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Study on the prevalence of facial lipoatrophy in patients infected by HIV virus receiving antiretroviral drugs - FRAN08-005
Sign or acronym PREFACE
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation 908505
General Aspects
Medical area Infectious diseases
Health determinants Iatrogenic
Keywords side-effects
Scientific investigator(s) (Contact)
Name of the director Cohen-Codar
Surname Isabelle
Address 10 rue d'Arcueil BP 90233 94528 RUNGIS
Email Isabelle.Cohen-Codar@abbvie.com
Organization ABBVIE
Collaborations
Funding
Funding status Private
Details ABBOTT France et Sanofi Aventis
Governance of the database
Sponsor(s) or organisation(s) responsible ABBOTT France
Organisation status Private
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Not-repeated cross-sectional studies (except case control studies)
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is is made on the basis of: Medication(s) taken
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Randomly selected doctors from a database of doctors working on HIV virus and identified in the file of the French medical board. Each doctor accepting to participate to the study will include his first 25 consecutive patients seen in consultation and responding to the eligibility criteria.
Database objective
Main objective Describe the prevalence of the facial lipoatrophy in patients infected by HIV virus and receiving antiretroviral drugs. Describe the prevalence of lipoatrophies and lipodystrophic mixed syndromes.
Evaluate the score of quality of life, using the patients multi-dimensional auto-questionnaire and specific ABCD "Assessment of Body Change and Distress".
Inclusion criteria Patient infected by HIV virus, receiving antiretroviral drugs for at least 1 month and coming to consultation at his usual follow-up center, during the period of the study, obtaining of the written consent for the collect and exploitation of his personal data.
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area Metropolitan France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 04/2009
Date of last collection (YYYY or MM/YYYY) 07/2009
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 2131
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Biological data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Paper self-questionnaire
Biological data (detail) Biological follow-up of the HIV infection.
Presence of a biobank No
Health parameters studied Health event/morbidity
Health care consumption and services
Care consumption (detail) Medicines consumption
Procedures
Data collection method Observation forms "patients" filled by the doctor and sent by mail to the society in charge of data management. Self-questionnaire ABCD filled by the patient and returned to the doctor in a sealed envelope, and then sent to the society in charge of data management.
Participant monitoring No
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Raw data access procedure to be defined. Results diffusion through publications (posters and articles)
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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