Clinical trial NCT02898987: Quality of Care in French HIV Infected Patients
Official title: Dataids Prospective Observational Cohort on Quality of Care of French HIV Infected Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Keywords: HIV
Hepatitis C
Comorbidities
AIDS
Lead sponsor: DatAids
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 :

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of HIV treated patients with HIV plasma viral load < 50 copies/mL
timeFrame: From date of enrollment, through study completion, an average of 6 months
Secondary outcomes:
measure: Proportion of HIV/HCV coinfected patients who start treatment with direct acting antivirals agents
timeFrame: From date of enrollment, through study completion, an average of 1 year
measure: Proportion of HIV patients according to their antiretroviral status : naive, on treatment, therapeutic stop
timeFrame: From date of enrollment, through study completion, an average of 1 year
measure: proportion of HIV/HCV patients with undetectable HCV viral load after treatment with direct acting antivirals agents
timeFrame: From date of enrollment, through study completion, an average of 1 year
measure: Proportion of HIV patients with CD4 cells count above 500 /ml
timeFrame: From date of enrollment, through study completion, an average of 1 year
measure: Incidence of antiretroviral modification due to simplification or failure
timeFrame: From date of enrollment, through study completion, an average of 1 year
measure: Incidence of aids events among patients enrolled in the cohort study
timeFrame: From date of enrollment, through study completion, an average of 1 year
measure: Incidence of non aids events among patients enrolled in the cohort study
timeFrame: From date of enrollment, through study completion, an average of 1 year
Other outcomes:
Locations:
city: Belfort
country: France
facility: Hôpital Nord Franche Comté
city: Besançon
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Brest
country: France
facility: CHRU Brest
city: Brive-la-Gaillarde
country: France
facility: Centre Hospitalier de Brive
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand - Hôpital Gabriel-Montpied
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: La Rochelle
country: France
facility: Centre Hospitalier de La Rochelle
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse - Hospices Civils de Lyon
city: Marseille
country: France
facility: Hôpital de la Conception - Assistance Publique des Hôpitaux de Marseille
city: Marseille
country: France
facility: Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille
city: Metz
country: France
facility: CHR Metz-Thionville
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Nancy
country: France
facility: CHU Nancy - Hôpital Brabois
city: Nantes
country: France
facility: CHU Nantes - Hôtel-Dieu
city: Nice
country: France
facility: CHU Nice
city: Niort
country: France
facility: Centre Hospitalier de Niort
city: Orléans
country: France
facility: CHR Orléans
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris
city: Paris
country: France
facility: Hôpital Bichat - Assistance Publique des Hôpitaux de Paris
city: Paris
country: France
facility: Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille
city: Reims
country: France
facility: CHU Reims - Hôpital Robert Debré
city: Rennes
country: France
facility: CHU Rennes - Hôpital Pontchaillou
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Étienne
country: France
facility: CHU St Etienne - Hôpital Nord
city: Strasbourg
country: France
facility: CHU Strasbourg - Hôpital Civil
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Purpan
city: Tourcoing
country: France
facility: CHU Tourcoing - Hôpital Guy Chatiliez
city: Troyes
country: France
facility: CH Troyes
city: Vannes
country: France
facility: CH Bretagne-Atlantique
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU de Guadeloupe
city: Fort-de-France
country: Martinique
facility: CHU de Martinique
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Pascal PUGLIESE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Martinique
name: André CABIE, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.