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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Other: additional blood sample

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • Centre Hospitalier Régional Universitaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: blood sample	Other: additional blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 1
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.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of Akt activation	Measure of Akt activation in live cells by flow cytometry	day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Georges HERBEIN, MD-PhD, CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2015
• Primary Completion (Actual): October 4, 2017
• Study Completion (Actual): October 4, 2017

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 8, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: P/2014/223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No