HIVDataids_PECNCT02898987
Quality of Care in French HIV Infected Patients
An observational study of HIV, run by DatAids at 39 sites in 3 countries.
Trial summary
The objective of the Dataids cohort is to continue a long-term, prospective collection of clinical, laboratory and therapeutic data on a large cohort of HIV infected patients seeking care in 15 HIV centers in France in order : 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 30,000 participants
- Where
- 39 sitesin 3 countries
- Study dates
- Jan 2016to Jan 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All HIV-infected patients seeking care at 15 centers using NADIS are included in the Dataids cohort after receiving oral information and giving written consent. NADIS is an electronic medical record (EMR) for HIV-, hepatitis B virus (HBV)- or hepatitis C virus (HCV)-infected adults seeking care in French public hospitals. The Dataids study recruits HIV-1 positive patients above the age of 18 years. Approximately 30 % of the patients are women. The study does not intervene with the clinical management of the patients followed, but only collects information from patient records.
Who may be able to join
- HIV-1 infected patients regardless of CD4 cell count and antiretroviral therapy status
Who cannot join
- Patients under 18 years of age
- Patients without written informed consent
Trial locations and contacts
39 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Solène SECHER contact
39 sites in 3 countries
France37 sites, 37 recruiting
- Recruiting
Hôpital Nord Franche Comté
Belfort
Vincent GENDRIN
Vincent GENDRIN
- Recruiting
CHU Besançon - Hôpital Jean Minjoz
Besançon
Catherine CHIROUZE
Catherine CHIROUZE
- Recruiting
CHRU Brest
Brest
Sylvain JAFFUEL
Sylvain JAFFUEL
- Recruiting
Centre Hospitalier de Brive
Brive-la-Gaillarde
Marion GAUDIN
Marion GAUDIN
- Recruiting
CHU Clermont-Ferrand - Hôpital Gabriel-Montpied
Clermont-Ferrand
Christine JACOMET
Christine JACOMET
- Recruiting
CHIC
Créteil
Isabelle DELACROIX
Isabelle DELACROIX
- Recruiting
Study site
Faye-l'Abbesse
Simon SUNDER
Simon SUNDER
- Recruiting
CHD Vendée
La Roche-sur-Yon
Dominique MERRIEN
Dominique MERRIEN
- Recruiting
Centre Hospitalier de La Rochelle
La Rochelle
Mariam RONCATO
Mariam RONCATO
- Recruiting
Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris
Le Kremlin-Bicêtre
Antoine CHERET
Antoine CHERET
- Recruiting
CHU Limoges
Limoges
Jean-François FAUCHER
Claire GENET
- Recruiting
Hôpital de la Croix-Rousse - Hospices Civils de Lyon
Lyon
Dulce ALFAIATE
Dulce ALFAIATE
- Recruiting
Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille
Marseille
Sylvie BREGIGEON-RONOT
Sylvie BREGIGEON-RONOT
- Recruiting
IHU - Assistance Publique des Hôpitaux de Marseille
Marseille
Amélie MENARD
Amélie MENARD
- Recruiting
CHR Metz-Thionville
Metz
Céline ROBERT
Céline ROBERT
- Recruiting
Hôpital Gui de Chauliac
Montpellier
Alain MAKINSON
Alain MAKINSON
- Recruiting
CHU Nancy - Hôpital Brabois
Nancy
Benjamin LEFEVRE
Benjamin LEFEVRE
- Recruiting
CHU Nantes - Hôtel-Dieu
Nantes
Clotilde ALLAVENA
Clotilde ALLAVENA
- Recruiting
CHU Nice
Nice
Pascal PUGLIESE
Pascal PUGLIESE
- Recruiting
CH Nîmes
Nîmes
Paul LOUBET
Paul LOUBET
- Recruiting
Centre Hospitalier de Niort
Niort
Simon SUNDER
Simon SUNDER
- Recruiting
CHR Orléans
Orléans
Laurent HOCQUELOUX
Laurent HOCQUELOUX
- Recruiting
Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris
Paris
Christine KATLAMA
Christine KATLAMA
- Recruiting
Hôpital Bichat - Assistance Publique des Hôpitaux de Paris
Paris
Yazdan YAZDANPANAH
Yazdan YAZDANPANAH
- Recruiting
Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris
Paris
Claudine DUVIVIER
Claudine DUVIVIER
- Recruiting
Centre Hospitalier de Cornouaille
Quimper
Nolwenn HALL
Nolwenn HALL
- Recruiting
CHU Reims - Hôpital Robert Debré
Reims
Firouze BANISADR
Firouze BANISADR
- Recruiting
CHU Rennes - Hôpital Pontchaillou
Rennes
Cédric ARVIEUX
Cédric ARVIEUX
- Recruiting
CH Rochefort
Rochefort
Mariam RONCATO
Mariam RONCATO
- Recruiting
CHU Rouen
Rouen
Manuel ETIENNE
Manuel ETIENNE
- Recruiting
CHU St Etienne - Hôpital Nord
Saint-Etienne
Amandine GAGNEUX-BRUNON
Amandine GAGNEUX-BRUNON
- Recruiting
CHU Strasbourg - Hôpital Civil
Strasbourg
Axel URSENBACH
Axel URSENBACH
- Recruiting
CHU Toulouse - Hôpital Purpan
Toulouse
Pierre DELOBEL
Pierre DELOBEL
- Recruiting
CHU Tourcoing - Hôpital Guy Chatiliez
Tourcoing
Olivier ROBINEAU
Olivier ROBINEAU
- Recruiting
CH Troyes
Troyes
Simona PAVEL
Simona PAVEL
- Recruiting
CH Bretagne-Atlantique
Vannes
Grégory CORVAISIER
Grégory CORVAISIER
- Recruiting
CHIV
Villeneuve-Saint-Georges
Pauline CARAUX-PAZ
Pauline CARAUX-PAZ
Guadeloupe1 site, 1 recruiting
- Recruiting
CHU de Guadeloupe
Pointe-à-Pitre
Isabelle LAMAURY
Isabelle LAMAURY
Martinique1 site, 1 recruiting
- Recruiting
CHU de Martinique
Fort-de-France
André CABIE
André CABIE
About this study
Official title: Dataids Prospective Observational Cohort on Quality of Care of French HIV Infected Patients
The objective of the Dataids cohort is to continue a long-term, prospective collection of clinical, laboratory and therapeutic data on a large cohort of HIV infected patients seeking care in 15 HIV centers in France in order :
- to provide and develop a surveillance system to describe clinical practice and temporal changes in the clinical course of HIV and HIV-related co-infections and co-morbidities in France.
- to assess the factors associated with the clinical, immunological and virological course of HIV infection and HIV-related co-infections and co-morbidities
Read more
The specific objectives are as follows
- To continue surveillance of HIV infection in France to describe temporal changes
- To evaluate the efficacy of ART and factors associated with ART efficacy
- To monitor the uptake and outcome of HCV therapy
Read the detailed description
The Dataids cohort is a prospective observational cohort of 30,000+ patients followed in 15+ HIV centers scattered throughout France. The Dataids cohort is an ongoing collaboration and patients have been enrolled into the study since 2010; the data are collected from the clinics as part of routine care. Included patients should be patients who had a scheduled visit in the outpatient clinic regardless of CD4 cell count, HIV viral load or ART status. For all HIV patients enrolled and under follow up, demographic data, immunological and virological data, serological evidence for infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis, laboratory, therapeutic and clinical data are collected annually.
- Conditions
- HIV
- Keywords
- HIV, Hepatitis C, Comorbidities, AIDS
- Medical subject headings
- Hepatitis C, Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of HIV treated patients with HIV plasma viral load < 50 copies/mL
Measured: From date of enrollment, through study completion, an average of 6 months
Secondary outcomes (7)
Proportion of HIV/HCV coinfected patients who start treatment with direct acting antivirals agents
Measured: From date of enrollment, through study completion, an average of 1 year
Proportion of HIV patients according to their antiretroviral status : naive, on treatment, therapeutic stop
Measured: From date of enrollment, through study completion, an average of 1 year
proportion of HIV/HCV patients with undetectable HCV viral load after treatment with direct acting antivirals agents
Measured: From date of enrollment, through study completion, an average of 1 year
Proportion of HIV patients with CD4 cells count above 500 /ml
Measured: From date of enrollment, through study completion, an average of 1 year
Incidence of antiretroviral modification due to simplification or failure
The observational cohort study concept means that Dataids does not collect Adverse Events, Adverse Reactions, Serious Adverse Reactions or Suspected Unexpected Serious Adverse Reactions as defined by pharmacovigilance requirements for marketing authorization holders. However, Dataids often analyses and reports specific clinical events of interest, occasionally related to drug classes, but more regularly with a focus on differences in treatment and care
Measured: From date of enrollment, through study completion, an average of 1 year
Incidence of aids events among patients enrolled in the cohort study
Measured: From date of enrollment, through study completion, an average of 1 year
Incidence of non aids events among patients enrolled in the cohort study
Measured: From date of enrollment, through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DatAids
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal PUGLIESE, MD, Principal investigator, Centre Hospitalier Universitaire de NiceAndré CABIE, MD-PhD, Principal investigator, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898987
- Sponsor's protocol ID
- DAT_001
- Acronym
- Dataids_PEC
- Status last verified
- Feb 2026
- First submitted
- 29 Aug 2016
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pugliese P, Cuzin L, Cabie A, Poizot-Martin I, Allavena C, Duvivier C, El Guedj M, de la Tribonniere X, Valantin MA, Dellamonica P; Nadis Group. A large French prospective cohort of HIV-infected patients: the Nadis Cohort. HIV Med. 2009 Sep;10(8):504-11. doi: 10.1111/j.1468-1293.2009.00719.x. Epub 2009 May 19.
PubMed 19486189Allavena C, Fleming SP, Deschanvres C, Mariot P, Chaillon A, Cheret A, Dellamonica P, Cabie A, Hocqueloux L; Dat'AIDS Study Group. Long-Term Effectiveness and Safety of Doravirine-Based Antiretroviral Regimens in Virologically Suppressed People with HIV: The French Dat'AIDS Cohort. Infect Dis Ther. 2026 Aug 19. doi: 10.1007/s40121-026-01422-4. Online ahead of print.
PubMed 42613399Makinson A, Bani-Sadr F, Palich R, Montes B, Maillard A, Duvivier C, Rey D, Becker A, Hocqueloux L, Raffi F; Dat'AIDS Study Group. Switch to Bictegravir/Tenofovir Alafenamide/Emtrictabine or Dolutegravir + Tenofovir Disoproxil Fumarate/Emtrictabine in Virologically Suppressed People With HIV: Outcomes in Real-world Setting With and Without Tenofovir Resistance. Clin Infect Dis. 2026 Jul 8;82(6):1007-1014. doi: 10.1093/cid/ciaf726.
PubMed 41511917Palich R, Hentzien M, Hocqueloux L, Duvivier C, Allavena C, Huleux T, Delobel P, Makinson A, Rey D, Cuzin L; Dat'AIDS Study Group. Country of birth is associated with antiretroviral therapy choice in treatment-naive persons with HIV in France. AIDS. 2023 Jul 15;37(9):1459-1466. doi: 10.1097/QAD.0000000000003588. Epub 2023 Apr 20.
PubMed 37115905Cuzin L, Allavena C, Cotte L, Delpierre C, Huleux T, Palich R, Delobel P, Raffi F, Cabie A; Dat'AIDS Study Group. No barrier to care, yet disparities in the HIV care continuum in France: a nationwide population study. J Antimicrob Chemother. 2021 May 12;76(6):1573-1579. doi: 10.1093/jac/dkab061.
PubMed 33704444Cotte L, Hocqueloux L, Lefebvre M, Pradat P, Bani-Sadr F, Huleux T, Poizot-Martin I, Pugliese P, Rey D, Cabie A; Dat'AIDS Study Group. Microelimination or Not? The Changing Epidemiology of Human Immunodeficiency Virus-Hepatitis C Virus Coinfection in France 2012-2018. Clin Infect Dis. 2021 Nov 2;73(9):e3266-e3274. doi: 10.1093/cid/ciaa1940.
PubMed 33400777Ursenbach A, Max V, Maurel M, Bani-Sadr F, Gagneux-Brunon A, Garraffo R, Ravaux I, Robineau O, Makinson A, Rey D; Dat'AIDS Study Group. Incidence of diabetes in HIV-infected patients treated with first-line integrase strand transfer inhibitors: a French multicentre retrospective study. J Antimicrob Chemother. 2020 Nov 1;75(11):3344-3348. doi: 10.1093/jac/dkaa330.
PubMed 32791523Le Guillou A, Pugliese P, Raffi F, Cabie A, Cuzin L, Katlama C, Allavena C, Drame M, Cotte L, Bani-Sadr F; Dat'AIDS Study Group. Reaching the Second and Third Joint United Nations Programme on HIV/AIDS 90-90-90 Targets Is Accompanied by a Dramatic Reduction in Primary Human Immunodeficiency Virus (HIV) Infection and in Recent HIV Infections in a Large French Nationwide HIV Cohort. Clin Infect Dis. 2020 Jul 11;71(2):293-300. doi: 10.1093/cid/ciz800.
PubMed 31612225Gantner P, Cotte L, Allavena C, Bani-Sadr F, Huleux T, Duvivier C, Valantin MA, Jacomet C, Joly V, Cheret A, Pugliese P, Delobel P, Cabie A, Rey D; Dat'AIDS Study Group. Higher rates of HBsAg clearance with tenofovir-containing therapy in HBV/HIV co-infection. PLoS One. 2019 Apr 18;14(4):e0215464. doi: 10.1371/journal.pone.0215464. eCollection 2019.
PubMed 30998789Hentzien M, Drame M, Delpierre C, Allavena C, Cabie A, Cuzin L, Rey D, Pugliese P, Hedelin G, Bani-Sadr F; Dat'AIDS Study Group. HIV-related excess mortality and age-related comorbidities in patients with HIV aged >/=60: a relative survival analysis in the French Dat'AIDS cohort. BMJ Open. 2019 Jan 25;9(1):e024841. doi: 10.1136/bmjopen-2018-024841.
PubMed 30782744Virlogeux V, Zoulim F, Pugliese P, Poizot-Martin I, Valantin MA, Cuzin L, Reynes J, Billaud E, Huleux T, Bani-Sadr F, Rey D, Fresard A, Jacomet C, Duvivier C, Cheret A, Hustache-Mathieu L, Hoen B, Cabie A, Cotte L; Dat'AIDS Study Group. Modeling HIV-HCV coinfection epidemiology in the direct-acting antiviral era: the road to elimination. BMC Med. 2017 Dec 18;15(1):217. doi: 10.1186/s12916-017-0979-1.
PubMed 29249202