NCT06458504

Brief Summary

We propose to demonstrate that HIV-1 and SARS-CoV-2 are capable of targeting long-lived HSPC with self-renewal capacities. These progenitors, thus transformed into host cells, can give rise to a durable source of infected cells with an impact on hematopoiesis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

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

First Submitted

Initial submission to the registry

June 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

October 25, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

June 10, 2024

Last Update Submit

March 17, 2025

Conditions

Keywords

HIV-1SARS-CoV-2Hematopoietic ProgenitorsVirus-inducedImmunosuppression

Outcome Measures

Primary Outcomes (1)

  • Evaluate if infected HSPC would modulate the bone marrow environment

    Evaluate whether these infected HSPC would modulate the bone marrow environment by upregulating inflammatory cytokines detrimental to lymphopoiesis.

    at 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* adult patients. * patients able to read and understand the information note. * no opposition to the use of biological samples. 45 subjects are required in our study: (A) 20 patients with FFPE osteomedullary biopsy prior to COVID-19 pandemic. Including : * 10 HIVpos patients selected based on biopsy results (normal, subnormal/minor lesion). * 10 HIVneg patients selected to match HIVpos patients, considering age and biological sex. (B) 25 HIVneg patients asymptomatic for COVID-19 for whom a myelogram or BM biopsy is prescribed as part of a search for haematological pathology or as part of lymphoma extension investigations.

You may qualify if:

  • HIV patients :
  • HIV-positive patients with a negative or positive viral load.
  • managed at Ambroise Paré Hospital.
  • patients with a bone marrow biopsy or myelogram performed as part of their care.
  • Healthy subjects without HIV - patients with a BM biopsy or myelogram performed as part of their care for a suspected hematological pathology.
  • Management at Ambroise Paré Hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology and interne medicine department, Ambroise Paré hospital - APHP

Boulogne-Billancourt, 92100, France

RECRUITING

Study Officials

  • Claude CAPRON, MD, PhD

    Laboratory of Immunology, Ambroise Paré hospital - APHP

    PRINCIPAL INVESTIGATOR
  • Fernando REAL, PhD

    Center for Infection and Immunity of Lille, INSERM U1019 - CNRS UMR9017, Institut Pasteur de Lille

    STUDY DIRECTOR

Central Study Contacts

Claude CAPRON, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 13, 2024

Study Start

October 25, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations