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Nice Human Immunodeficiency Virus (HIV) Cohort

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ClinicalTrials.gov Identifier: NCT03690063
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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Brief Summary:
Historically, the database on the HIV was organized within the framework of the medico-economic file of the human immunodeficiency (DMI-2), introduced jointly by the Direction of Hospitals (Mission AIDS) and the INSERM at the end of the 80s. Today this database is fed via the computerized medical record NADIS. Most part of the research works on the theme of the HIV take support on this database (DAD, EuroAIDS, Neuradapt).

Condition or disease Intervention/treatment
Human Immunodeficiency Virus Other: Follow up

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Nice Human Immunodeficiency Virus (HIV) Cohort
Actual Study Start Date : January 1996
Actual Primary Completion Date : January 1996
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Follow up
    Follow up of treatment, behavior, co-morbidity

Outcome Measures
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Primary Outcome Measures :
  1. change of the clinico-biological signs of the patients [ Time Frame: Each Year during 50 years ]
    change of the clinico-biological values form the start of the study, mesured every year, to the end of the study


Secondary Outcome Measures :
  1. number of the various type of adverse events related by type of treatments [ Time Frame: Each Year during 50 years ]
    Number of patients and laboratory data related to any events occurred such as : Death, Acute myocardial infarction , Ascites, Bone Mass Density , Diabetes mellitus, End Stage Renal Disease , Fibroscan stiffness , Bone fracture , Hepatic encephalopathy , Hepatorenal syndrome Invasive Cardiovascular Procedures , Kidney transplantation , Liver biopsy , Liver decompensation , Liver transplantation Non-AIDS defining malignancies , AIDS defining malignancies, Oesophageal variceal bleeding , Stroke


Other Outcome Measures:
  1. number of the various type of co-morbidity [ Time Frame: Each Year during 50 years ]
    Number of death, immediate cause of death, underlying conditions of death, ongoing risk factors in the year prior of the death, descripion of co-moirbidities (ongoing chronic conditions, prior cardiovascular diseases, history of depression, history of psychosis, liver diseases)


Eligibility Criteria
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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
Patients HIV innocents of any treatment and recently infected
Criteria

Inclusion Criteria:

  • Enrol consecutive patients with a scheduled visit in the outpatient clinic (regardless of CD4 cell count and ART status).

Exclusion Criteria:

-

Contacts and Locations
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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): NCT03690063


Contacts
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Contact: Christian PRADIER, Pr pradier.c@chu-nice.fr

Locations
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France
CHU de Nice Recruiting
Nice, France
Contact: Christian Pradier, Pr         
Contact       pradier.c@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Additional Information:

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03690063    
Other Study ID Numbers: 18-DSP-01
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Virus Diseases
Infections
Immune System Diseases
Blood-Borne Infections
 Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Slow Virus Diseases