Cytomegalovirus Infection in Patients With HIV-1 Infection (ACTHIV)

Participation of Cytomegalovirus Infection or an Autoimmune Process in T Lymphocyte Activation of HIV-1 Infected Patients With Undetectable Viral Load on Antiretroviral Therapy.

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.

Study Overview

• Status: Completed
• Conditions: Cytomegalovirus Infections; HIV-1-infection
• Intervention / Treatment: Procedure: Blood samples

Detailed Description

T cell activation plays a central role in HIV pathogenesis and is highly correlated to disease progression even in HIV patients virosuppressed on combined antiretroviral therapy since years. The mechanisms underlying this activation in virosuppressed patients are poorly understood. Identifying some factors involved in immune activation that can be targeted by therapies could optimize the treatment of HIV patients. 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: cytomégalovirus infection and auto-immune disorders.

• Study Type: Interventional
• Enrollment (Actual): 392
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bordeaux, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Single arm; Patient with confirmed HIV-1 infection	Procedure: Blood samples; Blood sample containing 3 ethylene-diamine-tetra-acetic acid tubes (7ml), 3 dry tubes (7ml) and 5 citrated tubes, ie 9 tubes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Isabelle PELLEGRIN, Dr, University Hospital, Bordeaux

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2010
• Primary Completion (Actual): December 13, 2010
• Study Completion (Actual): December 13, 2010

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: CHUBX 2009/22; 2009-A01063-54 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No