NCT04067869

Brief Summary

The purpose of this study is to assess the level of CD4 and CD8 T cell activation in an observational cohort study of HIV-1 patients, virosuppressed on combined antiretroviral therapy (\< 50 copies/ml) for at least 2 years and to focus on two factors that could participate in this activation: cytomegalovirus infection and auto-immune disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2010

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

June 10, 2026

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

August 22, 2019

Last Update Submit

June 8, 2026

Conditions

Cytomegalovirus InfectionsHIV-1-infection

Outcome Measures

Primary Outcomes (1)

  • Measurement of systemic lymphocyte activation

    Measured by the expression of HLA-DR and CD38 markers on the surface of CD4 + and CD8 + LT by flow cytometry

    At the screening

Study Arms (1)

Single arm

EXPERIMENTAL

Patient with confirmed HIV-1 infection

Procedure: Blood samples

Interventions

Blood samplesPROCEDURE

Blood sample containing 3 ethylene-diamine-tetra-acetic acid tubes (7ml), 3 dry tubes (7ml) and 5 citrated tubes, ie 9 tubes

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients included in the Aquitaine ANRS CO3 cohort aged 18 years or older (confirmed HIV-1 infection and at least one follow-up in the cohort),
  • plasma HIV-1 RNA \<50 copies / ml for at least 24 months under a highly active antiretroviral combination (treatment comprising at least 3 antiretroviral drugs) modified or initiated between 2005 and 2008,
  • Follow-up in one of the departments of Bordeaux University Hospital or Libourne Hospital,
  • Free, informed and written consent, signed by the patient and the investigator (Consent of the Aquitaine CO3 Cohort and linked to this specific study).

You may not qualify if:

  • Presence of 2 consecutive measurements of HIV RNA\> 50 copies / ml,
  • History of immunotherapy treatments (interleukin-2),
  • Hepatitis B or C co-infections,
  • Pregnancy
  • Breastfeeding
  • Symptomatic infectious episode in progress.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Bordeaux, France

Location

Related Publications (2)

  • Wittkop L, Bitard J, Lazaro E, Neau D, Bonnet F, Mercie P, Dupon M, Hessamfar M, Ventura M, Malvy D, Dabis F, Pellegrin JL, Moreau JF, Thiebaut R, Pellegrin I; Groupe d'Epidemiologie Clinique du SIDA en Aquitaine. Effect of cytomegalovirus-induced immune response, self antigen-induced immune response, and microbial translocation on chronic immune activation in successfully treated HIV type 1-infected patients: the ANRS CO3 Aquitaine Cohort. J Infect Dis. 2013 Feb 15;207(4):622-7. doi: 10.1093/infdis/jis732. Epub 2012 Nov 29.

    PMID: 23204178RESULT

  • Picat MQ, Pellegrin I, Bitard J, Wittkop L, Proust-Lima C, Liquet B, Moreau JF, Bonnet F, Blanco P, Thiebaut R; ANRS CO3 Aquitaine Cohort. Integrative Analysis of Immunological Data to Explore Chronic Immune T-Cell Activation in Successfully Treated HIV Patients. PLoS One. 2017 Jan 3;12(1):e0169164. doi: 10.1371/journal.pone.0169164. eCollection 2017.

    PMID: 28046052RESULT

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Isabelle PELLEGRIN, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

February 16, 2010

Primary Completion

December 13, 2010

Study Completion

December 13, 2010

Last Updated

June 10, 2026

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)