ClinicalTrials.gg
RecruitingNCT02898987Dataids_PECUpdated Feb 20, 2026

Quality of Care in French HIV Infected Patients

An observational study in HIV, sponsored by DatAids. Recruiting at 39 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by DatAids · Observational

From the registry’s dates

  • Started Jan 2016; still recruiting 10 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30,000
Ages
18 Years and older
Sex
All
01

Study 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. 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.
  2. to assess the factors associated with the clinical, immunological and virological course of HIV infection and HIV-related co-infections and co-morbidities

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.

02

Conditions studied

  • HIV

Keywords

  • HIV
  • Hepatitis C
  • Comorbidities
  • AIDS
03

In context

Hepatitis C

1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.

This study's planned enrollment of 30,000 is above the median of 218 across 435 observational studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

DatAids is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • -1 infected patients regardless of and antiretroviral therapy status

Exclusion criteria

Exclusion Criteria:

  • Patients under 18 years of age
  • Patients without written
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Proportion of HIV treated patients with HIV plasma viral load < 50 copies/mL

    Time frame: From date of enrollment, through study completion, an average of 6 months

Secondary outcomes

  1. Proportion of HIV/HCV coinfected patients who start treatment with direct acting antivirals agents

    Time frame: From date of enrollment, through study completion, an average of 1 year

  2. Proportion of HIV patients according to their antiretroviral status : naive, on treatment, therapeutic stop

    Time frame: From date of enrollment, through study completion, an average of 1 year

  3. proportion of HIV/HCV patients with undetectable HCV viral load after treatment with direct acting antivirals agents

    Time frame: From date of enrollment, through study completion, an average of 1 year

  4. Proportion of HIV patients with CD4 cells count above 500 /ml

    Time frame: From date of enrollment, through study completion, an average of 1 year

  5. 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

    Time frame: From date of enrollment, through study completion, an average of 1 year

  6. Incidence of aids events among patients enrolled in the cohort study

    Time frame: From date of enrollment, through study completion, an average of 1 year

  7. Incidence of non aids events among patients enrolled in the cohort study

    Time frame: From date of enrollment, through study completion, an average of 1 year

07

Study locations

39 of 39 sites recruiting
  • Hôpital Nord Franche Comté
    Belfort, France
    Recruiting
    • Vincent GENDRIN · Contact
    • Vincent GENDRIN · Principal investigator
  • CHU Besançon - Hôpital Jean Minjoz
    Besançon, France
    Recruiting
    • Catherine CHIROUZE · Contact
    • Catherine CHIROUZE · Principal investigator
  • CHRU Brest
    Brest, France
    Recruiting
    • Sylvain JAFFUEL · Contact
    • Sylvain JAFFUEL · Principal investigator
  • Centre Hospitalier de Brive
    Brive-la-Gaillarde, France
    Recruiting
    • Marion GAUDIN · Contact
    • Marion GAUDIN · Principal investigator
  • CHU Clermont-Ferrand - Hôpital Gabriel-Montpied
    Clermont-Ferrand, France
    Recruiting
    • Christine JACOMET · Contact
    • Christine JACOMET · Principal investigator
  • CHIC
    Créteil, France
    Recruiting
    • Isabelle DELACROIX · Contact
    • Isabelle DELACROIX · Principal investigator
  • Faye-l'Abbesse, France
    Recruiting
    • Simon SUNDER · Contact
    • Simon SUNDER · Principal investigator
  • CHD Vendée
    La Roche-sur-Yon, France
    Recruiting
    • Dominique MERRIEN · Contact
    • Dominique MERRIEN · Principal investigator
  • Centre Hospitalier de La Rochelle
    La Rochelle, France
    Recruiting
    • Mariam RONCATO · Contact
    • Mariam RONCATO · Principal investigator
  • Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris
    Le Kremlin-Bicêtre, France
    Recruiting
    • Antoine CHERET · Contact
    • Antoine CHERET · Principal investigator
  • CHU Limoges
    Limoges, France
    Recruiting
    • Jean-François FAUCHER · Contact
    • Claire GENET · Principal investigator
    • Jean-François FAUCHER · Principal investigator
  • Hôpital de la Croix-Rousse - Hospices Civils de Lyon
    Lyon, France
    Recruiting
    • Dulce ALFAIATE · Contact
    • Dulce ALFAIATE · Principal investigator
  • Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille
    Marseille, France
    Recruiting
    • Sylvie BREGIGEON-RONOT · Contact
    • Sylvie BREGIGEON-RONOT · Principal investigator
  • IHU - Assistance Publique des Hôpitaux de Marseille
    Marseille, France
    Recruiting
    • Amélie MENARD · Contact
    • Amélie MENARD · Principal investigator
  • CHR Metz-Thionville
    Metz, France
    Recruiting
    • Céline ROBERT · Contact
    • Céline ROBERT · Principal investigator
  • Hôpital Gui de Chauliac
    Montpellier, France
    Recruiting
    • Alain MAKINSON · Contact
    • Alain MAKINSON · Principal investigator
  • CHU Nancy - Hôpital Brabois
    Nancy, France
    Recruiting
    • Benjamin LEFEVRE · Contact
    • Benjamin LEFEVRE · Principal investigator
  • CHU Nantes - Hôtel-Dieu
    Nantes, France
    Recruiting
    • Clotilde ALLAVENA · Contact
    • Clotilde ALLAVENA · Principal investigator
  • CHU Nice
    Nice, France
    Recruiting
    • Pascal PUGLIESE · Contact
    • Pascal PUGLIESE · Principal investigator
  • Centre Hospitalier de Niort
    Niort, France
    Recruiting
    • Simon SUNDER · Contact
    • Simon SUNDER · Principal investigator
  • CH Nîmes
    Nîmes, France
    Recruiting
    • Paul LOUBET · Contact
    • Paul LOUBET · Principal investigator
  • CHR Orléans
    Orléans, France
    Recruiting
    • Laurent HOCQUELOUX · Contact
    • Laurent HOCQUELOUX · Principal investigator
  • Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris
    Paris, France
    Recruiting
    • Christine KATLAMA · Contact
    • Christine KATLAMA · Principal investigator
  • Hôpital Bichat - Assistance Publique des Hôpitaux de Paris
    Paris, France
    Recruiting
    • Yazdan YAZDANPANAH · Contact
    • Yazdan YAZDANPANAH · Principal investigator
  • Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris
    Paris, France
    Recruiting
    • Claudine DUVIVIER · Contact
    • Claudine DUVIVIER · Principal investigator
  • Centre Hospitalier de Cornouaille
    Quimper, France
    Recruiting
    • Nolwenn HALL · Contact
    • Nolwenn HALL · Principal investigator
  • CHU Reims - Hôpital Robert Debré
    Reims, France
    Recruiting
    • Firouze BANISADR · Contact
    • Firouze BANISADR · Principal investigator
  • CHU Rennes - Hôpital Pontchaillou
    Rennes, France
    Recruiting
    • Cédric ARVIEUX · Contact
    • Cédric ARVIEUX · Principal investigator
  • CH Rochefort
    Rochefort, France
    Recruiting
    • Mariam RONCATO · Contact
    • Mariam RONCATO · Principal investigator
  • CHU Rouen
    Rouen, France
    Recruiting
    • Manuel ETIENNE · Contact
    • Manuel ETIENNE · Principal investigator
  • CHU St Etienne - Hôpital Nord
    Saint-Etienne, France
    Recruiting
    • Amandine GAGNEUX-BRUNON · Contact
    • Amandine GAGNEUX-BRUNON · Principal investigator
  • CHU Strasbourg - Hôpital Civil
    Strasbourg, France
    Recruiting
    • Axel URSENBACH · Contact
    • Axel URSENBACH · Principal investigator
  • CHU Toulouse - Hôpital Purpan
    Toulouse, France
    Recruiting
    • Pierre DELOBEL · Contact
    • Pierre DELOBEL · Principal investigator
  • CHU Tourcoing - Hôpital Guy Chatiliez
    Tourcoing, France
    Recruiting
    • Olivier ROBINEAU · Contact
    • Olivier ROBINEAU · Principal investigator
  • CH Troyes
    Troyes, France
    Recruiting
    • Simona PAVEL · Contact
    • Simona PAVEL · Principal investigator
  • CH Bretagne-Atlantique
    Vannes, France
    Recruiting
    • Grégory CORVAISIER · Contact
    • Grégory CORVAISIER · Principal investigator
  • CHIV
    Villeneuve-Saint-Georges, France
    Recruiting
    • Pauline CARAUX-PAZ · Contact
    • Pauline CARAUX-PAZ · Principal investigator
  • CHU de Guadeloupe
    Pointe-à-Pitre, Guadeloupe
    Recruiting
    • Isabelle LAMAURY · Contact
    • Isabelle LAMAURY · Principal investigator
  • CHU de Martinique
    Fort-de-France, Martinique
    Recruiting
    • André CABIE · Contact
    • André CABIE · Principal investigator
08

References and documents

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 19486189 ↗
  • Palich 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 37115905 ↗
  • Cuzin 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 33704444 ↗
  • Cotte 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 33400777 ↗
  • Ursenbach 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 32791523 ↗
  • Le 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 31612225 ↗
  • Gantner 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 30998789 ↗
  • Hentzien 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 30782744 ↗
  • Virlogeux 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 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02898987
Lead sponsor
DatAids
Responsible party
Sponsor
First posted
Sep 13, 2016
Start date
Jan 2016
Primary completion
Jan 2030 (estimated)
Completion
Jan 2030 (estimated)
Last update
Feb 20, 2026

Study contacts

Pascal Pugliese, MD
Contact
pugliese.p@chu-nice.fr
0033492035802
Solène SECHER
Contact
dpo@dataids.org
Pascal PUGLIESE, MD
principal investigator · Centre Hospitalier Universitaire de Nice
André CABIE, MD-PhD
principal investigator · CHU de Martinique

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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