NCT07745530

Brief Summary

HIV/AIDS is a chronic disease that is difficult to eradicate because the virus persists as proviral DNA integrated into the host cells. Despite antiretroviral therapy, proviral DNA persists in lymphoid and myeloid reservoirs, whether circulating (memory CD4+ T cells) or tissue-based (macrophages). HIV reservoirs are highly heterogeneous, making it difficult to identify a specific biomarker or cell profile for a given reservoir. A distinctive feature of HIV reservoirs may be the selective interaction between reservoir cells and platelets. The presence of HIV in platelets could impact disease progression, particularly by triggering the reversal of HIV latency and leading to residual viral production. The frequency of platelets containing circulating virus in the blood is approximately 0.1% of the total platelet volume. Although seemingly negligible, this would represent a daily input of 10⁸ platelets harboring the virus. Furthermore, patients whose platelets contain HIV are primarily those with persistent immunological failure, known as "immunological non-responders" (InR). The regulation of the size (number and frequency) of the HIV reservoir by platelets is not known. However, HIV-containing platelets form more conjugates with CD4+ T cells than HIV-free platelets. While HIV-containing platelets do not productively infect cells, they induce metabolic dysfunction in CD4+ T cells (aerobic glycolysis). Increased aerobic glycolysis is a hallmark of T cell activation and senescence. This suggests an interconnection between the presence of the virus in platelets, the size of the reservoir, and immune dysfunction in HIV.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
2mo left

Started Apr 2025

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Apr 2025Oct 2026

Study Start

First participant enrolled

April 1, 2025

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

July 29, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

hivplatelet

Outcome Measures

Primary Outcomes (1)

  • In vivo evaluation of the formation of platelet-PBMC conjugates enriched in latent or active reservoirs and of their transcriptional competence

    In vivo evaluation of the formation of platelet-PBMC conjugates enriched in latent or active reservoirs, correlated with immune status through the following parameters: Frequency of CD4+ T lymphocytes associated with platelets and/or platelet components, Frequency of platelet-associated CD4+ T cells carrying HIV RNA, and ex vivo HIV reactivation; Number of integrated HIV provirus copies in CD4+ T cells associated or not with platelets. Monitoring of the transcriptional competence of platelet-associated reservoirs ex vivo, and the capacity of platelets to reactivate these reservoirs (latency reversal) in vitro based on the following criterion: Frequency of J-Lat GFP+ cells (indicating a reactivated provirus in this reporter cell) after coculture with platelets obtained from individuals of the different experimental groups.

    at enrollment

Study Arms (3)

Immunological non-responders 1

EXPERIMENTAL

Immunological non-responders (\<500 CD4+ T cells/µL, undetectable viral load for \>2 years) with a CD4+ T cell nadir below 100.

Other: blood sampling

Immunological responders

EXPERIMENTAL

Immunological responders (\>500 CD4+ T cells/µL, undetectable viral load for \>2 years)

Other: blood sampling

Immunological non-responders 2

EXPERIMENTAL

Immunological non-responders (\<500 CD4+ T cells/µL, undetectable viral load for \>2 years) with a CD4+ T cell nadir between 200 and 500

Other: blood sampling

Interventions

During a routine consultation, a specific 40 mL blood sample will be collected for the study.

Immunological non-responders 1Immunological non-responders 2Immunological responders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients living with HIV with an undetectable viral load for more than 2 years
  • Beneficiary of a social security scheme or rightful claimant;
  • Patients able to read and understand the information sheet;
  • Having signed the consent form.

You may not qualify if:

  • being unable to give free and informed consent;
  • pregnant or breastfeeding woman;
  • being under guardianship, curatorship, or a protection mandate;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Tourcoing

Tourcoing, 59200, France

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Olivier Robineau, MD, PhD

    Centre Hospitalier de Tourcoing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Jacques VITAGLIANO, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 4, 2026

Study Start

April 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

August 4, 2026

Record last verified: 2026-07

Locations