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NCT Number: NCT02898987

Quality of Care in 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

Recruiting

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Nord Franche Comté, Belfort, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Pascal Pugliese, MD

CONTACT

[email protected]

0033492035802

Solène SECHER

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

DatAids

Other

Registry information

Official study title

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

Acronym: Dataids_PEC

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Sep 13, 2016
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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