NCT05973825

Immuno-virological Evaluation of Persons Living With HIV (PLWH)

Immuno-virological Evaluation of Persons Living With HIV (PLWH) Who Initiated Anti-retroviral Treatment (ART) During Acute HIV Infection and of PLWH on Long Term ART

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a dual arm (arm 1 and arm 2) multi-centric non-randomized (prospective) study. Two new multicentric cohorts will be set up in 4 Belgian HIV reference centers (UZ Gent, UZ Brussel, University Hospital Liege and St. Pierre Hospital Brussels): cohort 1 will comprise PLWH in whom ART was initiated during acute HIV infection minimum 3 years ago but no more than 10 years ago (short-term ART cohort); cohort 2 will comprise PLWH on ART since \>20 years (long-term ART cohort). Participants will be included based on suppressed viremia and uninterrupted ART since initiation. Participants will undergo one blood sampling and one leukapheresis. In and exclusion criteria are described below.

Detailed description

This project aims to gain new knowledge and insights into the viral reservoir establishment and HIV Latency as well as to develop new powerful tools to study latency reversal, that will ultimately contribute to research into an HIV curative treatment. The study objectives are * To collect and store state of the art peripheral blood samples (60 vials of 50 X106 PBMC's) from two patient cohorts, 10 acute seroconverters and 10 long-term ART-treated patients . * To characterize and compare the latent reservoir in blood samples from both cohorts as for the proviral genome, transcriptome, epigenome and T cell receptor level * To perform an immunological profiling of infected cells. * To evaluate available drugs that induce either a block-and-lock or a shock-and-kill in in vitro interventions using blood samples from both cohorts * To accelerate the negative selection of transcriptionally competent proviruses in vitro and determine the role of the different determinants. * To make all data available for the different partners and integrate all data acquired.

Conditions

• HIV-1-infection
• HIV Seropositivity

Interventions

Type	Name	Description
PROCEDURE	Leucapheresis	leucapheresis is a procedure in which a large amount of blood cells are obtained by an apheresis procedure

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-07-12
• Completion: 2029-07-12
• First posted: 2023-08-03
• Last updated: 2024-07-15

Locations

1 site across 1 country: Belgium