OVIHD: HIV Patients Cohort

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT02203006
Collaborator
(none)
1,296
1
1
233.4
5.6

Study Details

Study Description

Brief Summary

The purpose of this study is to improve our knowledge concerning HIV infection, treated or not, in the current conditions of care to optimize it.

Condition or Disease Intervention/Treatment Phase
  • Biological: OVIHD
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1296 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Constitution of an Open Monocentric Cohort of HIV Infected Patients
Actual Study Start Date :
Oct 19, 2011
Anticipated Primary Completion Date :
Oct 1, 2030
Anticipated Study Completion Date :
Apr 1, 2031

Arms and Interventions

Arm Intervention/Treatment
Other: OVIHD

Cohort and a blood sample collection will be done with data and blood of HIV infected patients

Biological: OVIHD
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:
  • Blood sample
  • Outcome Measures

    Primary Outcome Measures

    1. HIV infection [10 years]

      The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)

    Secondary Outcome Measures

    1. Comorbidity and complication in HIV infected patients [10 years]

      The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)

    2. efficiency of the current antiretroviral therapeutic diets [10 years]

      The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)

    3. Blood sample collection [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Aged ≥18 years old,

    • Patients with an HIV infection

    • patients having given their written informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Hôtel Dieu Paris France 75004

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Study Director: Jean Marc Tréluyer, MD, PhD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT02203006
    Other Study ID Numbers:
    • IDRCB : 2010-A00417-32
    First Posted:
    Jul 29, 2014
    Last Update Posted:
    Apr 14, 2021
    Last Verified:
    Apr 1, 2021
    Keywords provided by Assistance Publique - Hôpitaux de Paris

    Study Results

    No Results Posted as of Apr 14, 2021