Nice Human Immunodeficiency Virus (HIV) Cohort

Human Immunodeficiency Virus Clinical Trial

Official title:

Nice Human Immunodeficiency Virus (HIV) Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03690063
• Other study ID #: 18-DSP-01
• Status: Recruiting
• Start date: January 1996
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Christian PRADIER, Pr
• Email: pradier.c[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2024
• Est. primary completion date: January 1996
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Other:
• Follow up
Follow up of treatment, behavior, co-morbidity

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of the various type of co-morbidity	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)	Each Year during 50 years
Primary	change of the clinico-biological signs of the patients	change of the clinico-biological values form the start of the study, mesured every year, to the end of the study	Each Year during 50 years
Secondary	number of the various type of adverse events related by type of treatments	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	Each Year during 50 years