HIV
Conditions
Keywords
HIV, Hepatitis C, Comorbidities, AIDS
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.
Interventions
None listed
Sponsors
DatAids
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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 | — |
| Proportion of HIV patients with CD4 cells count above 500 /ml | From date of enrollment, through study completion, an average of 1 year | — |
| Incidence of antiretroviral modification due to simplification or failure | 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 |
| Incidence of aids events among patients enrolled in the cohort study | From date of enrollment, through study completion, an average of 1 year | — |
| Incidence of non aids events among patients enrolled in the cohort study | From date of enrollment, through study completion, an average of 1 year | — |
Countries
France, Guadeloupe, Martinique
Contacts
CONTACTPascal Pugliese, MD
CONTACTSolène SECHER
PRINCIPAL_INVESTIGATORPascal PUGLIESE, MD
Centre Hospitalier Universitaire de Nice
PRINCIPAL_INVESTIGATORAndré CABIE, MD-PhD
CHU de Martinique
Outcome results
None listed