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

University Hospital of Bordeaux

Status and phase: Completed; Phase 3

Conditions: HIV-1-infection; Cytomegalovirus Infections

Treatments: Procedure: Blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT04067869

CHUBX 2009/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 392 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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392 participants in 1 patient group

Single arm

Experimental group

Description:

Patient with confirmed HIV-1 infection

Treatment:

Procedure: Blood samples