Quality of Care in French HIV Infected Patients

Official title

Dataids Prospective Observational Cohort on Quality of Care of French HIV Infected Patients

Overview

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.

Primary outcome measures

• 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 outcome measures (7)

• 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]
• 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]
• 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]
• 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]
• Incidence of antiretroviral modification due to simplification or failure [Time frame: From date of enrollment, through study completion, an average of 1 year]
• 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]
• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 37 centers

• Hôpital Nord Franche Comté — Belfort
• CHU Besançon - Hôpital Jean Minjoz — Besançon
• CHRU Brest — Brest
• Centre Hospitalier de Brive — Brive-la-Gaillarde
• CHU Clermont-Ferrand - Hôpital Gabriel-Montpied — Clermont-Ferrand
• CHIC — Créteil
• Center not named — Faye-l'Abbesse
• CHD Vendée — La Roche-sur-Yon
• … and 29 more centers

Guadeloupe · 1 center

• CHU de Guadeloupe — Pointe-à-Pitre

Martinique · 1 center

• CHU de Martinique — Fort-de-France

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 30782744

Identifiers

NCT: NCT02898987 · DAT_001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗