PREFACE - Study on the prevalence of facial lipoatrophy in patients infected by HIV virus receiving antiretroviral drugs - FRAN08-005 
Head :
Cohen-Codar Isabelle
Last update : 07/01/2019 | Version : 3 | ID : 115
| 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 |
| 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 |
