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

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ClinicalTrials.gov Identifier: NCT02858414
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infection Other: additional blood sample Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
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
Actual Study Start Date : April 2, 2015
Actual Primary Completion Date : October 4, 2017
Actual Study Completion Date : October 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: blood sample Other: additional blood sample



Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. Measure of Akt activation [ Time Frame: day 1 ]
    Measure of Akt activation in live cells by flow cytometry



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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


Locations
France
Centre Hospitalier Régional Universitaire
Besançon, France, 25030
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Georges HERBEIN, MD-PhD Centre Hospitalier Universitaire de Besancon

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02858414     History of Changes
Other Study ID Numbers: P/2014/223
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
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