ITMO Santé Publique
ITMO Santé Publique
Date de modification : 01/07/2018 | Version : 3 | ID : 1252
| Général | |
| Identification | |
| Nom détaillé | Observational study of the sociodemographic characteristics of patients infected with HIV B subtype versus HIV non-B subtype and having recently started their first course of antiretroviral treatment. |
| Sigle ou acronyme | BINOME |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CNIL n°906292 |
| Thématiques générales | |
| Domaine médical |
Infectious diseases |
| Déterminants de santé |
Occupation Social and psychosocial factors |
| Mots-clés | anti-retroviral drug treatment (ARV), viral subtype, Protease inhibitors (PI), non-nucleoside reverse transcriptase inhibitors (NNRTI), HIV |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Cohen-Codar |
| Prénom | Isabelle |
| Adresse | 10 rue d'Arcueil BP 90233 Rungis |
| Isabelle.Cohen-Codar@abbvie.com | |
| Organisme | ABBVIE |
| Collaborations | |
| Financements | |
| Financements |
Private |
| Précisions | ABBOTT France |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | ABBOTT France |
| Statut de l’organisation |
Secteur Privé |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Not-repeated cross-sectional studies (except case control studies) |
| Origine du recrutement des participants |
A selection of health institutions and services |
| Critère de sélection des participants |
Medication(s) taken |
| Le recrutement dans la base de données s'effectue dans le cadre d'une étude interventionnelle |
No |
| Informations complémentaires concernant la constitution de l'échantillon | Random selection of doctors from the database of doctors working on HIV and listed in the file of the French Medical Board.Each physician accepting to participate in the study will include the first 4 consecutive patients examined in consultation and meeting the eligibility criteria of which 2 patients in group 1 and 2 patients in group 2. |
| Objectif de la base de données | |
| Objectif principal |
Describe and compare the socio-demographic characteristics of patients infected with an HIV-1 of subtype B (group 1) compared to non-B (group 2) treated with a first anti-retroviral drug treatment.
Compare according to the HIV subtype the stage of the disease (clinical, viro-immunology, co-morbidities) at the time treatment is initiated, compare between the 2 groups (B and non-B) the conditions for taking the treatment and the perception by the patient of the therapy and of its effects. Identification of any correlation between these latter parameters and the change in the disease between the initiation and the first line ARV and the inclusion in the cohort: - change in the viral load (VL) according to the ARV treatment (PI, NNRTI) and of the HIV subtype (B or non-B), of the CD4, - any occurrence of clinical events, - any changes in treatments and reasons. |
| Critères d'inclusion | Age > 18 years, obtaining of written consent for the collection of this personal data, patient infected by the HIV-1 virus, patient coming to consult for the first or second routine follow-up visit (i.e. 1 to 4 months) after the initiation of the ARV treatment, genotype available when the treatment is initiated. |
| Type de population | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population concernée |
Sick population |
| Sexe |
Male Woman |
| Champ géographique |
National |
| Détail du champ géographique | Metropolitan France |
| Collecte | |
| Dates | |
| Année du premier recueil | 04/2007 |
| Année du dernier recueil | 07/2008 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
< 500 individuals |
| Détail du nombre d'individus | 304 |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Clinical data Declarative data Biological data |
| Données cliniques, précisions |
Direct physical measures Medical registration |
| Données déclaratives, précisions |
Paper self-questionnaire Face to face interview |
| Données biologiques, précisions | biological monitoring of the HIV infection |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Health event/morbidity Health care consumption and services Quality of life/health perception |
| Consommation de soins, précisions |
Medicines consumption |
| Modalités | |
| Mode de recueil des données | "Patient" observation sheets completed by the physician and sent by the post to the company in charge of data management. Visual analog scales completed by the patient and remitted to the physician and then sent to the company in charge of data management. |
| Suivi des participants |
No |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Lien vers le document | http://www.ncbi.nlm.nih.gov/pubmed/21233637 |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) |
Methods for accessing the raw data are currently being defined.
Distribution of the results of the study: (see the tab for more information) Poster: O. Bouchaud, V. Le Moing, F. Simon, P. NgoVan, P. Perre, L. Hocqueloux, B. Lebouche, S. Carret, B. Spire, Subjects infected with B versus non-B HIV 1 Subtypes in France: Differences in Social and demographic Conditions, but Similar Short-term virological Outcome on Therapy, 16th Conference on Retroviruses and Opportunistic Infection (CROI 2009), Montreal, Canada, 8-11 Feb 2009. Article: O. Bouchaud, V. Le Moing, F. Simon, P. NgoVan, P. Perre, L. Hocqueloux, B. Lebouche, S. Carret, B. Spire, Similar Short-Term Efficacy of Antiretroviral Therapy in Patients Infected with HIV B and non-B Subtypes strains in France, J. Acquir Immune Defic Syndr, Vol 56, N°2, February 1, 2011, 67-69 |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
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