Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients (EURECA)
Primary Purpose
HIV Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
additional blood sample
Sponsored by
About this trial
This is an interventional basic science trial for HIV Infection
Eligibility 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
Sites / Locations
- Centre Hospitalier Régional Universitaire
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
blood sample
Arm Description
Outcomes
Primary Outcome Measures
Measure of the integrated viral reservoir size
Measure by Alu-PCR. Results are given in number of integrated proviral DNA copies per 1 million cells.
Measure of the proviral reservoir size
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
Measure of Akt activation in live cells by flow cytometry
Full Information
NCT ID
NCT02858414
First Posted
July 29, 2016
Last Updated
December 5, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02858414
Brief Title
Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients
Acronym
EURECA
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 2, 2015 (Actual)
Primary Completion Date
October 4, 2017 (Actual)
Study Completion Date
October 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
blood sample
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
additional blood sample
Primary Outcome Measure Information:
Title
Measure of the integrated viral reservoir size
Description
Measure by Alu-PCR. Results are given in number of integrated proviral DNA copies per 1 million cells.
Time Frame
day 1
Title
Measure of the proviral reservoir size
Description
Measure by Total Proviral HIV DNA detection kit. Results are given in number of total proviral DNA copies per 1 million cells.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Measure of Akt activation
Description
Measure of Akt activation in live cells by flow cytometry
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges HERBEIN, MD-PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire
City
Besançon
ZIP/Postal Code
25030
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients
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