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

Primary Purpose

Cytomegalovirus Infections, HIV-1-infection

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Blood samples

About this trial

This is an interventional treatment trial for Cytomegalovirus Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Patient with confirmed HIV-1 infection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04067869

First Posted

August 22, 2019

Last Updated

August 26, 2019

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT04067869

Brief Title

Cytomegalovirus Infection in Patients With HIV-1 Infection

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

February 16, 2010 (Actual)

Primary Completion Date

December 13, 2010 (Actual)

Study Completion Date

December 13, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cytomegalovirus Infections, HIV-1-infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

392 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Experimental

Arm Description

Patient with confirmed HIV-1 infection

Intervention Type

Procedure

Intervention Name(s)

Blood samples

Intervention Description

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

Primary Outcome Measure Information:

Title

Measurement of systemic lymphocyte activation

Description

Measured by the expression of HLA-DR and CD38 markers on the surface of CD4 + and CD8 + LT by flow cytometry

Time Frame

At the screening

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Isabelle PELLEGRIN, Dr

Organizational Affiliation

University Hospital, Bordeaux

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Cytomegalovirus Infection in Patients With HIV-1 Infection

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