Quality of Care in French HIV Infected Patients (Dataids_PEC)

February 26, 2024 updated by: DatAids

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 :

  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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Belfort, France
        • Recruiting
        • Hopital Nord Franche Comte
        • Contact:
          • Vincent GENDRIN
        • Principal Investigator:
          • Vincent GENDRIN
      • Besançon, France
        • Recruiting
        • CHU Besançon - Hôpital Jean Minjoz
        • Contact:
          • Catherine CHIROUZE
        • Principal Investigator:
          • Catherine CHIROUZE
      • Brest, France
        • Recruiting
        • CHRU Brest
        • Principal Investigator:
          • Sylvain JAFFUEL
        • Contact:
          • Sylvain JAFFUEL
      • Brive-la-Gaillarde, France
        • Recruiting
        • Centre Hospitalier de Brive
        • Contact:
          • Bruno ABRAHAM
        • Principal Investigator:
          • Bruno ABRAHAM
      • Clermont-Ferrand, France
        • Recruiting
        • CHU Clermont-Ferrand - Hôpital Gabriel-Montpied
        • Principal Investigator:
          • Christine JACOMET
        • Contact:
          • Christine JACOMET
      • La Roche-sur-Yon, France
        • Recruiting
        • CHD Vendée
        • Contact:
          • Dominique MERRIEN
        • Principal Investigator:
          • Dominique MERRIEN
      • La Rochelle, France
        • Recruiting
        • Centre Hospitalier de La Rochelle
        • Contact:
          • Mariam RONCATO
        • Principal Investigator:
          • Mariam RONCATO
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris
        • Principal Investigator:
          • Antoine CHERET
        • Contact:
          • Antoine CHERET
      • Limoges, France
        • Recruiting
        • Chu Limoges
        • Contact:
          • Jean-François FAUCHER
        • Principal Investigator:
          • Jean-François FAUCHER
        • Principal Investigator:
          • Claire GENET
      • Lyon, France
        • Recruiting
        • Hôpital de la Croix-Rousse - Hospices Civils de Lyon
        • Contact:
          • Laurent COTTE
        • Principal Investigator:
          • Laurent COTTE
      • Marseille, France
        • Recruiting
        • Hôpital de la Conception - Assistance Publique des Hôpitaux de Marseille
        • Contact:
          • Isabelle RAVAUX
        • Principal Investigator:
          • Isabelle RAVAUX
      • Marseille, France
        • Recruiting
        • Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille
        • Contact:
          • Sylvie BREGIGEON-RONOT
        • Principal Investigator:
          • Sylvie BREGIGEON-RONOT
      • Metz, France
        • Recruiting
        • CHR Metz-Thionville
        • Contact:
          • Céline ROBERT
        • Principal Investigator:
          • Céline ROBERT
      • Montpellier, France
        • Recruiting
        • Hopital Gui de Chauliac
        • Contact:
          • Alain MAKINSON
        • Principal Investigator:
          • Alain MAKINSON
      • Nancy, France
        • Recruiting
        • CHU Nancy - Hôpital Brabois
        • Contact:
          • Benjamin LEFEVRE
        • Principal Investigator:
          • Benjamin LEFEVRE
      • Nantes, France
        • Recruiting
        • CHU Nantes - Hôtel-Dieu
        • Contact:
          • François RAFFI
        • Principal Investigator:
          • François RAFFI
      • Nice, France
        • Recruiting
        • CHU Nice
        • Principal Investigator:
          • Pascal PUGLIESE
        • Contact:
          • Pascal PUGLIESE
      • Niort, France
        • Recruiting
        • Centre Hospitalier de Niort
        • Principal Investigator:
          • Simon SUNDER
        • Contact:
          • Simon SUNDER
      • Orléans, France
        • Recruiting
        • CHR Orléans
        • Principal Investigator:
          • Laurent HOCQUELOUX
        • Contact:
          • Laurent HOCQUELOUX
      • Paris, France
        • Recruiting
        • Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris
        • Contact:
          • Christine KATLAMA
        • Principal Investigator:
          • Christine KATLAMA
      • Paris, France
        • Recruiting
        • Hôpital Bichat - Assistance Publique des Hôpitaux de Paris
        • Contact:
          • Yazdan YAZDANPANAH
        • Principal Investigator:
          • Yazdan YAZDANPANAH
      • Paris, France
        • Recruiting
        • Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris
        • Principal Investigator:
          • Claudine Duvivier
        • Contact:
          • Claudine DUVIVIER
      • Quimper, France
        • Recruiting
        • Centre Hospitalier de Cornouaille
        • Contact:
          • Nolwenn HALL
        • Principal Investigator:
          • Nolwenn HALL
      • Reims, France
        • Recruiting
        • CHU Reims - Hôpital Robert Debré
        • Contact:
          • Firouze BANISADR
        • Principal Investigator:
          • Firouze BANISADR
      • Rennes, France
        • Recruiting
        • Chu Rennes - Hopital Pontchaillou
        • Principal Investigator:
          • Pierre TATTEVIN
        • Contact:
          • Pierre TATTEVIN
      • Rouen, France
        • Recruiting
        • CHU Rouen
        • Contact:
          • Manuel ETIENNE
        • Principal Investigator:
          • Manuel ETIENNE
      • Saint-Étienne, France
        • Recruiting
        • CHU St Etienne - Hôpital Nord
        • Contact:
          • Amandine GAGNEUX-BRUNON
        • Principal Investigator:
          • Amandine GAGNEUX-BRUNON
      • Strasbourg, France
        • Recruiting
        • CHU Strasbourg - Hôpital Civil
        • Principal Investigator:
          • David REY
        • Contact:
          • David REY
      • Toulouse, France
        • Recruiting
        • Chu Toulouse - Hopital Purpan
        • Contact:
          • Pierre DELOBEL
        • Principal Investigator:
          • Pierre DELOBEL
      • Tourcoing, France
        • Recruiting
        • CHU Tourcoing - Hôpital Guy Chatiliez
        • Contact:
          • Olivier ROBINEAU
        • Principal Investigator:
          • Olivier ROBINEAU
      • Troyes, France
        • Recruiting
        • CH Troyes
        • Contact:
          • Simona PAVEL
        • Principal Investigator:
          • Simona PAVEL
      • Vannes, France
        • Recruiting
        • CH Bretagne-Atlantique
        • Contact:
          • Grégory CORVAISIER
        • Principal Investigator:
          • Grégory CORVAISIER
  • Guadeloupe
      • Pointe-à-Pitre, Guadeloupe
        • Recruiting
        • CHU de Guadeloupe
        • Principal Investigator:
          • Isabelle LAMAURY
        • Contact:
          • Isabelle LAMAURY
  • Martinique
      • Fort-de-France, Martinique
        • Recruiting
        • CHU de Martinique
        • Contact:
          • André CABIE
        • Principal Investigator:
          • André CABIE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From date of enrollment, through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
From date of enrollment, through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DatAids

Investigators

  • Principal Investigator: Pascal PUGLIESE, MD, Centre Hospitalier Universitaire de Nice
  • Principal Investigator: André CABIE, MD-PhD, CHU de Martinique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimated)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DAT_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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