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Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients (EURECA)

This study is currently recruiting participants.
Verified July 2016 by Centre Hospitalier Universitaire de Besancon
Sponsor:
ClinicalTrials.gov Identifier:
NCT02858414
First Posted: August 8, 2016
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon
  Purpose
This study evaluates the impact of highly active antiretroviral therapy on the size of the latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The activation state of the cells will be assessed, by measuring the activation of Akt, to determine its influence on the size of the viral reservoirs.

Condition Intervention
HIV Infection Other: additional blood sample

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients: EURECA (ERANET to Unravel New Roads to Eradication and a Cure for AIDS) Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • Measure of the integrated viral reservoir size [ Time Frame: day 1 ]
    Measure by Alu-PCR. Results are given in number of integrated proviral DNA copies per 1 million cells.

  • Measure of the proviral reservoir size [ Time Frame: day 1 ]
    Measure by Total Proviral HIV DNA detection kit. Results are given in number of total proviral DNA copies per 1 million cells.


Secondary Outcome Measures:
  • Measure of Akt activation [ Time Frame: day 1 ]
    Measure of Akt activation in live cells by flow cytometry


Estimated Enrollment: 40
Study Start Date: February 2015
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: blood sample Other: additional blood sample

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected patients under Highly Active Anti-Retroviral Therapy (HAART) or Naïve from treatment

Exclusion Criteria:

  • Age limits
  • Pregnancy
  • Legal restrictions to consent
  Contacts and Locations
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): NCT02858414


Contacts
Contact: Georges HERBEIN, MD-PhD g.herbein@chu-besancon.fr

Locations
France
Centre Hospitalier Régional Universitaire Recruiting
Besançon, France, 25030
Contact: Elise ROBERT       e1robert@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Georges HERBEIN, MD-PhD Centre Hospitalier Universitaire de Besancon
  More Information

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02858414     History of Changes
Other Study ID Numbers: P/2014/223
First Submitted: July 29, 2016
First Posted: August 8, 2016
Last Update Posted: February 15, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases


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