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Quality of Care in French HIV Infected Patients (Dataids_PEC)

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ClinicalTrials.gov Identifier: NCT02898987
Recruitment Status : Enrolling by invitation
First Posted : September 13, 2016
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
DatAids

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

Condition or disease
HIV

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
Actual Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dataids Prospective Observational Cohort on Quality of Care of French HIV Infected Patients
Study Start Date : January 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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

  6. 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 ]
  7. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898987


Sponsors and Collaborators
DatAids
Investigators
Principal Investigator: Pascal PUGLIESE, MD Centre Hospitalier Universitaire de Nice
Principal Investigator: André CABIE, MD-PhD CHU de Martinique