- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02203006
HIV Patients Cohort (OVIHD)
Constitution of an Open Monocentric Cohort of HIV Infected Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Since the arrival of highly active tritherapies, HIV infection became mainly an ambulatory chronic pathology centred on a long term care taking into account the complication of long-term treatment as well as the arisen of new problem bound to a prolonged survival and ageing. So the care is more and more in a prevention and screening approach with in particular the care of metabolic and cardiovascular complication due to antiretroviral treatment.
As a reorganization of the coverage of the HIV infected people take place on the Hotel Dieu Hospital it thus seems important to double this care optimization with a clinical research side. This will be done in constituting an HIV patient cohort including a blood sample collection to contribute to the vigilance of the complication to due the infection.
Our ultimate objective is to optimize the selection of the treatment. It is important to do it to be able to have, on many years duration, precise clinical information and biological sample allowing to realize later some assay and analyse the influence of some genetic markers.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75004
- Hôpital Hôtel Dieu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged ≥18 years old,
- Patients with an HIV infection
- patients having given their written informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: OVIHD
Cohort and a blood sample collection will be done with data and blood of HIV infected patients
|
7 ml of blood will be taken during a follow-up consultation and kept in a biological collection.
Clinical data will be collected in a database.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HIV infection
Time Frame: 10 years
|
The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comorbidity and complication in HIV infected patients
Time Frame: 10 years
|
The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)
|
10 years
|
|
efficiency of the current antiretroviral therapeutic diets
Time Frame: 10 years
|
The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)
|
10 years
|
|
Blood sample collection
Time Frame: 10 years
|
To put in relation the clinical-biological relevant biological or genetic data of the follow-up a blood sample will be constituted.
7 ml will be taken to each patient and kept in a collection
|
10 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Jean-Marc Tréluyer, MD, PhD, Assistance Publique - Hopitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDRCB : 2010-A00417-32
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