YZATIS - Evaluation et évolution de la prise en charge thérapeutique à moyen terme des patients séropositifs pour le VIH-1 traités avec une combinaison antirétrovirale incluant Atazanavir 
Head :
Bennai Yacia, Bristol-Myers Squibb
Schmidely Nathalie, Bristol-Myers Squibb
Schmidely Nathalie, Bristol-Myers Squibb
Last update : 09/05/2017 | Version : 1 | ID : 128
| General | |
| Identification | |
| Detailed name | Evaluation et évolution de la prise en charge thérapeutique à moyen terme des patients séropositifs pour le VIH-1 traités avec une combinaison antirétrovirale incluant Atazanavir |
| Sign or acronym | YZATIS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°04-1334 (18/10/2004) |
| General Aspects | |
| Medical area |
Infectious diseases |
| Others (details) | HIV |
| Keywords | care, Atazanavir |
| Scientific investigator(s) (Contact) | |
| Name of the director | Bennai |
| Surname | Yacia |
| Address | 3, rue J. Monier - 92500 Rueil Malmaison |
| Phone | +33 (0)1 58 83 60 00 |
| yacia.bennai@bms.com | |
| Unit | Bristol-Myers Squibb |
| Name of the director | Schmidely |
| Surname | Nathalie |
| Address | 3, rue J. Monier - 92500 Rueil Malmaison |
| Phone | +33 (0)1 58 83 60 00 |
| nathalie.schmidely@bms.com | |
| Unit | Bristol-Myers Squibb |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Bristol-Myers Squibb |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Bristol-Myers Squibb France (BMS) |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| 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. | random sampling in clusters |
| Database objective | |
| Main objective | Describe the arrangements for caring for patients treated by a combination of treatments including ATAZANAVIR according to the grounds for introducing the treatment (virological failure of the previous treatment or other) |
| Inclusion criteria |
M or F, aged 18 years or older, seropositive for HIV-1, treated via a combination of ARV treatments including ATV for which the main reason for introduction of the current treatment was: - virological failure of the previous treatment OR - another reason. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | National representativeness |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2004 |
| Date of last collection (YYYY or MM/YYYY) | 2006 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 626 |
| 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) | cholesterol, TG, glycemia, bilirubin, liver enzymes, VL & CD4 (if available) |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | Specific observation notebooks |
| Participant monitoring |
Yes |
| Details on monitoring of participants | M3, M6, M12 |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | publication |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
