Cytomegalovirus Infection in Patients With HIV-1 Infection

NCT04067869 | Completed Phase 3

• 1 other identifier: CHUBX 2009/22
• Study Type: interventional
• Target: 392
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cytomegalovirus Infections; HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single arm

EXPERIMENTAL

Patient with confirmed HIV-1 infection

Procedure: Blood samples

Interventions

Blood samples PROCEDURE

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

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Isabelle PELLEGRIN, Dr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: February 16, 2010
• Primary Completion: December 13, 2010
• Study Completion: December 13, 2010
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share