Quality of Care in French HIV Infected Patients

NCT02898987 | Recruiting

• 1 other identifier: DAT_001
• Study Type: observational
• Target: 30,000
• Locations: 3 countries
• Sites: 39

Brief 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 :

• 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

Conditions

HIV

Keywords

HIV; Hepatitis C; Comorbidities; AIDS

Outcome Measures

Primary Outcomes (1)

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

  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

  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

  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

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

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

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

• Incidence of antiretroviral modification due to simplification or failure

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• HIV-1 infected patients regardless of CD4 cell count and antiretroviral therapy status

You may not qualify if:

• Patients under 18 years of age
• Patients without written informed consent

Sponsors & Collaborators

• DatAids: lead

Study Sites (39)

Hôpital Nord Franche Comté

Belfort, France

RECRUITING

CHU Besançon - Hôpital Jean Minjoz

Besançon, France

RECRUITING

CHRU Brest

Brest, France

RECRUITING

Centre Hospitalier de Brive

Brive-la-Gaillarde, France

RECRUITING

CHU Clermont-Ferrand - Hôpital Gabriel-Montpied

Clermont-Ferrand, France

RECRUITING

CHIC

Créteil, France

RECRUITING

Unknown Facility

Faye-l'Abbesse, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, France

RECRUITING

Centre Hospitalier de La Rochelle

La Rochelle, France

RECRUITING

Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris

Le Kremlin-Bicêtre, France

RECRUITING

CHU Limoges

Limoges, France

RECRUITING

Hôpital de la Croix-Rousse - Hospices Civils de Lyon

Lyon, France

RECRUITING

Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille

Marseille, France

RECRUITING

IHU - Assistance Publique des Hôpitaux de Marseille

Marseille, France

RECRUITING

CHR Metz-Thionville

Metz, France

RECRUITING

Hôpital Gui de Chauliac

Montpellier, France

RECRUITING

CHU Nancy - Hôpital Brabois

Nancy, France

RECRUITING

CHU Nantes - Hôtel-Dieu

Nantes, France

RECRUITING

CHU Nice

Nice, France

RECRUITING

Centre Hospitalier de Niort

Niort, France

RECRUITING

CH Nîmes

Nîmes, France

RECRUITING

CHR Orléans

Orléans, France

RECRUITING

Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris

Paris, France

RECRUITING

Hôpital Bichat - Assistance Publique des Hôpitaux de Paris

Paris, France

RECRUITING

Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris

Paris, France

RECRUITING

Centre Hospitalier de Cornouaille

Quimper, France

RECRUITING

CHU Reims - Hôpital Robert Debré

Reims, France

RECRUITING

CHU Rennes - Hôpital Pontchaillou

Rennes, France

RECRUITING

CH Rochefort

Rochefort, France

RECRUITING

CHU Rouen

Rouen, France

RECRUITING

CHU St Etienne - Hôpital Nord

Saint-Etienne, France

RECRUITING

CHU Strasbourg - Hôpital Civil

Strasbourg, France

RECRUITING

CHU Toulouse - Hôpital Purpan

Toulouse, France

RECRUITING

CHU Tourcoing - Hôpital Guy Chatiliez

Tourcoing, France

RECRUITING

CH Troyes

Troyes, France

RECRUITING

CH Bretagne-Atlantique

Vannes, France

RECRUITING

CHIV

Villeneuve-Saint-Georges, France

RECRUITING

CHU de Guadeloupe

Pointe-à-Pitre, Guadeloupe

RECRUITING

CHU de Martinique

Fort-de-France, Martinique

RECRUITING

Related Publications (9)

• 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.

  PMID: 19486189 RESULT

• 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.

  PMID: 37115905 DERIVED

• 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.

  PMID: 33704444 DERIVED

• 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.

  PMID: 33400777 DERIVED

• 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.

  PMID: 32791523 DERIVED

• 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.

  PMID: 31612225 DERIVED

• 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.

  PMID: 30998789 DERIVED

• 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.

  PMID: 30782744 DERIVED

• 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.

  PMID: 29249202 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Pascal PUGLIESE, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

• André CABIE, MD-PhD

  CHU de Martinique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal Pugliese, MD

CONTACT

0033492035802; pugliese.p@chu-nice.fr

Solène SECHER

CONTACT

dpo@dataids.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 13, 2016
• Study Start: January 1, 2016
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1); MA (1); FR (37)