Cytomegalovirus Infection in Patients With HIV-1 Infection

HIV-1-infection Clinical Trial

— ACTHIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04067869
• Other study ID #: CHUBX 2009/22
• Status: Completed
• Phase: Phase 3
• Start date: February 16, 2010
• Est. completion date: December 13, 2010

Study information

• Verified date: August 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: December 13, 2010
• Est. primary completion date: December 13, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infections
• HIV-1-infection
• Infection

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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