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Cytomegalovirus Infection in Patients With HIV-1 Infection

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04067869
Acronym
ACTHIV
Enrollment
392
Registered
2019-08-28
Start date
2010-02-16
Completion date
2010-12-13
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus Infections, HIV-1-infection

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.

Interventions

PROCEDUREBlood samples

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

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Measurement of systemic lymphocyte activationAt the screeningMeasured by the expression of HLA-DR and CD38 markers on the surface of CD4 + and CD8 + LT by flow cytometry

Countries

France

Contacts

PRINCIPAL_INVESTIGATORIsabelle PELLEGRIN, Dr

University Hospital, Bordeaux

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026