Cytomegalovirus Infection in Patients With HIV-1 Infection

Phase 3

Completed

• Conditions: HIV-1-infection; Cytomegalovirus Infections
• Interventions: Procedure: Blood samples

• Registration Number: NCT04067869
• Lead Sponsor: University Hospital, Bordeaux

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.

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 Timeline

• Study Start: 2010-02-16
• Primary Completion: 2010-12-13
• Study Completion: 2010-12-13
• Status Verified: 2019-08
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-22
• Last Update Submitted: 2019-08-26
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Blood samples	Patient with confirmed HIV-1 infection

Primary Outcome Measures

Name	Time	Method
Measurement of systemic lymphocyte activation	At the screening	Measured by the expression of HLA-DR and CD38 markers on the surface of CD4 + and CD8 + LT by flow cytometry