Role of Viral Reservoir, Immune Activation and Depletion in Persistent Viremia Persistent Viremia in People Living With HIV on Antiretroviral Therapy

NCT07015164 | Not Yet Recruiting

• 1 other identifier: APHP240349
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Low-level HIV replication in a patient on effective antiretroviral therapy is a relatively frequent event, generating stress for both patient and physician, due to the fear of subsequent virological escape with emergence of resistant virus(es) and/or transmission of such virus(es) to partner(s). Understanding the origin of this low-level viral replication would enable informed therapeutic decisions to be made (therapeutic intensification, modification of antiretroviral (ARV) treatment with the use of molecules belonging to other therapeutic classes, or maintenance of the status quo), and reassure patients of the scientific rationale guiding their course of action. This is a single-center, cross-sectional study designed to compare the parameters of the cellular viral reservoir between a group of participants with persistent viral replication under ARV treatment and a group of participants with perfect viral replication control (stable virological suppression). Patients meeting the eligibility criteria will be offered the opportunity to have two additional blood tubes taken for research purposes, as part of an integrated visit to monitor HIV infection, which already includes a venipuncture. Patients meeting these criteria will have been previously identified by a feasibility survey carried out by the clinical research team of the Infectious and Tropical Diseases Department (SMIT) at Hôpital Bichat-Claude Bernard (AP-HP. Nord).

Conditions

HIV

Keywords

HIV; antiretroviral treatment; viral reservoir; persistent viremia

Outcome Measures

Primary Outcomes (1)

• Quantification of HIV-1 cellular reservoir parameters using molecular techniques

  Assessment of the HIV-1 cellular reservoir in peripheral blood mononuclear cells (PBMCs) using the following molecular methods: Quantification of total HIV-1 DNA by real-time PCR Quantification of cell-associated HIV-1 RNA by real-time PCR Quantification of intact proviral genomes by digital PCR These measurements will be compared between two groups of HIV-1-infected individuals under antiretroviral therapy: Group 1: participants with persistent low-level viremia Group 2: participants with sustained virological suppression

  At study inclusion (single blood sample)

Secondary Outcomes (3)

• Genetic diversity of HIV-1 proviruses integrated in cellular genomes

  At study inclusion (single blood sample)

• Phylogenetic analysis of plasma HIV-1 sequences

  At study inclusion (single blood sample)

• Expression levels of immune activation and exhaustion markers on CD4+ and CD8+ T cells

  At study inclusion (single blood sample)

Study Arms (1)

identification of clinical and immunological parameters

Identification of clinical and immunological parameters associated with persistence of low-level viremia on effective antiretroviral therapy in people living with HIV with persistent low plasma viral load on ARV treatment, and in people living with HIV with perfect control of viral replication (stable virological suppression).

Eligibility Criteria

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

Study Population

Adults living with HIV-1, under antiretroviral therapy (ART) for at least 2 years, recruited from a single clinical center. The study includes two groups: individuals with persistent low-level viremia and individuals with sustained virological suppression.

PLHIV with persistent low plasma viral load on ARV therapy : * PLHIV \> 18 years of age * On ARV treatment for at least 3 years * Taking one of the following ARV treatments: * Tenofovir Alafenamide + Emtricitabine + Bictegravir * Abacavir + Lamivudine + Dolutegravir * Tenofovir Disoproxil Fumarate + Emtricitabine + Dolutegravir * Tenofovir Disoproxil Fumarate + Lamivudine \+ Doravirine * Abacavir + Lamivudine + Doravirine * With at least 3 consecutive HIV plasma viral loads between 50 and 1,000 copies/mL over a period of at least 12 months * Absence of resistance mutations to current antiretroviral treatments PLHIV group with perfect control of viral replication (stable virological suppression): * PLWH \> 18 years of age * On ARV treatment for at least 3 years * Taking one of the following ARV treatments: * Tenofovir Alafenamide + Emtricitabine + Bictegravir * Abacavir + Lamivudine + Dolutegravir * Tenofovir Disoproxil Fumarate + Emtricitabine + Dolutegravir * Tenofovir Disoproxil Fumarate + Lamivudine \+ Doravirine * Abacavir + Lamivudine + Doravirine * With at least 3 plasma HIV viral loads below 50 copies/mL over a period of at least 24 months * Absence of resistance mutations to current antiretroviral treatments

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat, service des Maladies Infectieuses et Tropicales

Paris, Paris, 75018, France

Location

Central Study Contacts

Jade GHOSN, professor

CONTACT

0140258000; jade.ghosn@aphp.fr

Quentin LEHINGRAT, Doctor

CONTACT

0140258080; quentin.lehingrat@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 11, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)