ITMO public health
Last update : 09/05/2017 | Version : 3 | ID : 60063
| General | |
| Identification | |
| Detailed name | Cohort of HIV-Seropositive Individuals Infected by Use of Intravenous drugs: Prospective Study in Marseille, Avignon, Nice and Ile-de-France |
| Sign or acronym | MANIF-2000 FOLLOWED BY MANIF-2 |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL |
| General Aspects | |
| Medical area |
Infectious diseases |
| Health determinants |
Addictions |
| Keywords | related diseases, hepatic, psychiatric, genital and gynaecological, secondary side-effects from treatment, Health episodes, cardiovascular, neurological, infectious, prevention |
| Scientific investigator(s) (Contact) | |
| Name of the director | Carrieri |
| Surname | Maria-Patrizia |
| Address | 13006 MARSEILLE |
| Phone | + 33 (0)4 96 10 28 75 |
| Pmcarrieri@aol.com | |
| Unit | ORS PACA - INSERM U912 |
| Organization | OBSERVATOIRE REGIONAL DE LA SANTE |
| Name of the director | Obadia |
| Surname | Yolande |
| Address | 13006 MARSEILLE |
| Phone | +33 (0)4 91 59 89 10 |
| yolande.obadia@inserm.fr | |
| Unit | ORS PACA |
| Organization | OBSERVATOIRE REGIONAL DE LA SANTE |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | ANRS, Conseil Général des bouches du Rhône, SIDACTION |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | OBSERVATOIRE REGIONAL DE LA SANTE PACA |
| Organisation status |
Public |
| 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 carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective Inclusion cut-off date: 01/07/1998 |
| Database objective | |
| Main objective | General objective: MANIF 2000 is a cohort of HIV-1 seropositive patients that have been infected through intravenous drug use. Patients should have an initial CD4 count of > 300/mm3. The initial aim of this study was to compare HIV progression according to whether patients were still active addicts, substituting or sober. This goal was revised in light of the changes in HIV history with the release of highly active combination therapy and the treatment of addicts with buprenorphine substitution. MANIF 2000 has become an observational cohort study focused on risk-related sexual behaviours associated with drug addiction, as well as adherence to therapy and interaction between substitution and treatment. Secondary objectives: - To determine the impact of depression and HIV treatment adherence on clinical progression; - to determine the impact of retention in substitution treatment on virological success. |
| Inclusion criteria | HIV-1 or HIV-2 seropositive patients that have been infected through intravenous drug use with an initial CD4 count greater than 300/mm3 and at clinical stage A or B. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Local |
| Detail of the geography area | Multicentric cohort throughout France (10 centres): Marseille, Avignon, Nice, Ile de France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 07/1995 |
| Date of last collection (YYYY or MM/YYYY) | 06/2006 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 467 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Paraclinical data (detail) | Puncture, biopsy |
| Biological data (detail) | Type of samples taken: Haematology, chemistry, immunology, HIV serology, viral load, other serological tests such as Hepatitis B and C and freezing. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma |
| Details of biobank content | Serum bank, plasma bank |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Self-administered questionnaire: entry from a paper questionnaire Interviews: entry from a paper questionnaire Clinical examinations: handwritten. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 11 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Hal-MANIF-2000 |
| Description | List of publications in HAL |
| Link to the document | http://tinyurl.com/Pubmed-MANIF-2000 |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may not be used by academic teams Data may not be used by industrial teams |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
No access |
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