Quality of Care in French HIV Infected Patients

HIV Clinical Trial

— Dataids_PEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02898987
• Other study ID #: DAT_001
• Status: Recruiting
• Start date: January 2016
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: DatAids
• Contact: Pascal Pugliese, MD
• Phone: 0033492035802
• Email: pugliese.p[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
France	Hôpital Nord Franche Comté	Belfort
France	CHU Besançon - Hôpital Jean Minjoz	Besançon
France	CHRU Brest	Brest
France	Centre Hospitalier de Brive	Brive-la-Gaillarde
France	CHU Clermont-Ferrand - Hôpital Gabriel-Montpied	Clermont-Ferrand
France	CHD Vendée	La Roche-sur-Yon
France	Centre Hospitalier de La Rochelle	La Rochelle
France	Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris	Le Kremlin-Bicêtre
France	CHU Limoges	Limoges
France	Hôpital de la Croix-Rousse - Hospices Civils de Lyon	Lyon
France	Hôpital de la Conception - Assistance Publique des Hôpitaux de Marseille	Marseille
France	Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille	Marseille
France	CHR Metz-Thionville	Metz
France	Hôpital Gui de Chauliac	Montpellier
France	CHU Nancy - Hôpital Brabois	Nancy
France	CHU Nantes - Hôtel-Dieu	Nantes
France	CHU Nice	Nice
France	Centre Hospitalier de Niort	Niort
France	CHR Orléans	Orléans
France	Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris	Paris
France	Hôpital Bichat - Assistance Publique des Hôpitaux de Paris	Paris
France	Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris	Paris
France	Centre Hospitalier de Cornouaille	Quimper
France	CHU Reims - Hôpital Robert Debré	Reims
France	CHU Rennes - Hôpital Pontchaillou	Rennes
France	CHU Rouen	Rouen
France	CHU St Etienne - Hôpital Nord	Saint-Étienne
France	CHU Strasbourg - Hôpital Civil	Strasbourg
France	CHU Toulouse - Hôpital Purpan	Toulouse
France	CHU Tourcoing - Hôpital Guy Chatiliez	Tourcoing
France	CH Troyes	Troyes
France	CH Bretagne-Atlantique	Vannes
Guadeloupe	CHU de Guadeloupe	Pointe-à-Pitre
Martinique	CHU de Martinique	Fort-de-France

Sponsors (1)

Lead Sponsor	Collaborator
DatAids

Countries where clinical trial is conducted

France,  Guadeloupe,  Martinique, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Proportion of HIV patients with CD4 cells count above 500 /ml		From date of enrollment, through study completion, an average of 1 year
Secondary	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	From date of enrollment, through study completion, an average of 1 year
Secondary	Incidence of aids events among patients enrolled in the cohort study		From date of enrollment, through study completion, an average of 1 year
Secondary	Incidence of non aids events among patients enrolled in the cohort study		From date of enrollment, through study completion, an average of 1 year

External Links

•   Related Info