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

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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 29, 2016
First Posted Date  ICMJE August 8, 2016
Last Update Posted Date December 6, 2018
Actual Study Start Date  ICMJE April 2, 2015
Actual Primary Completion Date October 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
Measure of Akt activation [ Time Frame: day 1 ]
Measure of Akt activation in live cells by flow cytometry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE HIV Infection
Intervention  ICMJE Other: additional blood sample
Study Arms  ICMJE Experimental: blood sample
Intervention: Other: additional blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2018)
41
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2016)
40
Actual Study Completion Date  ICMJE October 4, 2017
Actual Primary Completion Date October 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02858414
Other Study ID Numbers  ICMJE P/2014/223
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Georges HERBEIN, MD-PhD Centre Hospitalier Universitaire de Besancon
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP