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HIV Patients Cohort (OVIHD)

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ClinicalTrials.gov Identifier: NCT02203006
Recruitment Status : Recruiting
First Posted : July 29, 2014
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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
Patients Affected by the HIV Biological: OVIHD Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 19, 2011
Estimated Primary Completion Date : October 2030
Estimated Study Completion Date : April 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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 Name: Blood sample




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged ≥18 years old,
  • Patients with an HIV infection
  • patients having given their written informed consent.

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): NCT02203006


Contacts
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Contact: Jean Paul Viard, MD +331 42 34 88 41 / 36 jean-paul.viard@aphp.fr
Contact: Sandra COLAS 00 33 1 71 19 64 32 sandra.colas@aphp.fr

Locations
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France
Hôpital Hôtel Dieu Recruiting
Paris, France, 75004
Contact: Jean Paul Viard, MD    +331 42 34 88 41 / 36    jean-paul.viard@aphp.fr   
Contact: Sandra COLAS    00 33 1 71 19 64 32    sandra.colas@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Jean Marc Tréluyer, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02203006    
Other Study ID Numbers: IDRCB : 2010-A00417-32
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Keywords provided by Assistance Publique - Hôpitaux de Paris:
HIV,
infection,
cohort