Last update : 08/08/2020 | Version : 2 | ID : 6744
| General | |
| Identification | |
| Detailed name | Multicentric cohort of HIV patients with extreme progression profiles | 
| Sign or acronym | ANRS CO21 CODEX | 
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP IdF VII le 25/7/2011 n° 11-033 ; autorisation AFSSAPS AEC/B110900-40 | 
| General Aspects | |
| Medical area | 			
							Hematology Immunology Infectious diseases  | 
		
| Health determinants | 			
							Lifestyle and behavior Medicine  | 
		
| Keywords | Extreme progression, CD4+ lymphocytes, asymptomatic, antiretroviral treatment | 
| Scientific investigator(s) (Contact) | |
| Name of the director | Lambotte | 
| Surname | Olivier | 
| Address | 63 rue Gabriel Péri 94276 Le Kremlin Bicêtre | 
| Phone | 33 (0)1 49 59 67 54 | 
| olivier.lambotte@bct.aphp.fr | |
| Unit | U1184 Immunité Virale et auto-immunité | 
| Organization | Université Paris Sud, Institut National de la Santé et de la Recherche | 
| Collaborations | |
| Participation in projects, networks and consortia | 			
				Yes | 
		
| Funding | |
| Funding status | 			
					Public | 
		
| Details | Agence Nationale de Recherche sur le Sida | 
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Agence Nationale de Recherche sur le Sida | 
| Organisation status | 
																														Public | 
				
| Presence of scientific or steering committees | 			
				Yes | 
		
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database | 			
							Study databases | 
		
| Study databases (details) | 			
							Cohort study | 
		
| 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. | Sample includes: - Long-term asymptomatic subjects with HIV-1 for at least 8 years with a CD4 count above 600/mm3, with a stable or increasing rate (positive or zero slope) during the last 5 years regardless of the viral load in the absence of antiretroviral treatment - Subjects who have been HIV-1 seropositive for at least five years (HIC group), asymptomatic, with the last 5 viral loads at 400 copies/mL regardless of CD4 lymphocyte count in the absence of antiretroviral treatment - subjects meeting the dual definition the ALT and HIC group | 
| Database objective | |
| Main objective | To study the clinical and immunovirological progression of patients infected with HIV, and to determine the virus and host parameters associated with non-progression of infection. | 
| Inclusion criteria | - Men or women - between 18 and 85 years old - covered by social security - subject infected with HIV-1 but not receiving antiretroviral treatment | 
| 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 | 
		
| Pathology | U60 - | 
| Gender | 			
					Male Woman  | 
		
| Geography area | 			
					National | 
		
| Detail of the geography area | France | 
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 | 
| Size of the database | |
| Size of the database (number of individuals) | 			
					< 500 individuals | 
		
| Details of the number of individuals | 222 | 
| Data | |
| Database activity | 			
					Current data collection | 
		
| Type of data collected | 			
					Declarative data Biological data  | 
		
| Declarative data (detail) | 			
					Paper self-questionnaire | 
		
| Biological data (detail) | - serum - plasma - cells | 
| Presence of a biobank | 			
				Yes | 
		
| Contents of biobank | 			
					Serum Plasma Blood cells isolated  | 
		
| Details of biobank content | Cell bank retained by INSERM Unit U1012. Available for research projects subject to the opinion of the Scientific Council. | 
| Health parameters studied | 			
					Health event/morbidity Health event/mortality  | 
		
| Procedures | |
| Data collection method | Data on clinical events, virological, genetic and immunological parameters associated with non-progression. | 
| Participant monitoring | 			
				Yes | 
		
| Monitoring procedures | 			
					Monitoring by contact with the referring doctor | 
		
| Details on monitoring of participants | Study duration of six years with a minimum of one annual visit. | 
| Links to administrative sources | 			
				No | 
		
| Promotion and access | |
| Promotion | |
| Link to the document | http://clinicaltrials.gov/show/NCT01520844 | 
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=ANRS+C021+OR+ANRS+CO21+OR+%28codex+AND+Anrs%29 | 
| Description | List of publications in Pubmed | 
| Access | |
| Dedicated website | https://cesp.inserm.fr | 
| Terms of data access (charter for data provision, format of data, availability delay) | Data available for collaboration requests by research teams who wish to work with the cohort teams. | 
| Access to aggregated data | 			
					Access on specific project only | 
		
| Access to individual data | 			
					Access on specific project only | 
		
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