Nice Human Immunodeficiency Virus (HIV) Cohort

September 27, 2018 updated by: Centre Hospitalier Universitaire de Nice
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients HIV innocents of any treatment and recently infected

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Each Year during 50 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Each Year during 50 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Each Year during 50 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1996

Primary Completion (Actual)

January 1, 1996

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

October 1, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-DSP-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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