ClinicalTrials.gg
RecruitingNCT05973825Updated Sep 21, 2026

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

An interventional study of Leucapheresis in HIV-1-infection and HIV Seropositivity, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • HIV-1-infection
  • HIV Seropositivity

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03

In context

HIV Seropositivity

194 studies on the registry are indexed under HIV Seropositivity; 11 are open to participants now.

This study's planned enrollment of 24 is below the median of 105 across 114 interventional studies indexed under HIV Seropositivity.

Browse HIV Seropositivity studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Cohort 1: short-term ART cohort

  • Documented -1 infection
  • Able and willing to provide written
  • Age = or >18 years and \< 80 years
  • ART started during a documented recent HIV-1 infection (acute HIV infection, defined as:

    • Clinical symptoms of acute seroconversion and incomplete Western Blot, or
    • Negative screening test within the past 6 months and incomplete Western Blot, or
    • Risk contact within the \<3 months and presumable primo-infection with or without clinical symptoms and incomplete Western Blot.
  • Being on ART since minimum 2 years and maximum 10 years
  • Participants should have had a routine plasma viral load measurement at least once a year.
  • Viral load \< 40 or \<50 copies/ml determined by the assay (used in the local centers) for at least 3 years (one blip \< 200 copies/ml is allowed)
  • Ability and willingness to have blood samples collected and stored for 20 years and used for various research purposes.
  • Patients with HIV-1 subtype B are preferred for inclusion (as most of the complex assays are subtype B specific). However, if the investigators do not reach our target of 10 participants, patients infected with other subtypes will be allowed to enter the study. (Primers will subsequently be adapted to the patient-specific proviral sequences).

Cohort 2: long-term ART cohort

  • Documented HIV-1 infection
  • Able and willing to provide written informed consent
  • Age = or >18 years and \< 80 years
  • Being on ART since at least 20 years
  • ART should not have been started during a documented recent HIV-1 infection (acute HIV infection), defined as:

    • Clinical symptoms of acute seroconversion and incomplete Western Blot or
    • Negative screening test within the past 6 months and incomplete Western Blot or
    • Risk contact within \<3 months and presumable primo-infection with or without clinical symptoms and incomplete Western Blot.
  • Patients should have had a routine plasma viral load measurement at least once a year.
  • Routine plasma viral load \< 40 or \<50 copies/ml determined by the assay used in the local centres for at least 20 years (one blip \< 200 copies/ml is allowed if it occurred >10 years ago)
  • Ability and willingness to have blood samples collected and stored for 20 years and used for various research purposes.
  • Participants with HIV-1 subtype B are preferred for inclusion (as most of the complex assays are subtype B specific). However, if the investigators do not reach our target of 10 participants, patients infected with other subtypes will be allowed to enter the study. (Primers will subsequently be adapted to the patient-specific proviral sequences).

Exclusion criteria

Exclusion Criteria:

  • Previous or current history of opportunistic infection (AIDS defining events as defined in category C of the Centers for Disease Control and Prevention (CDC) clinical classification), consisting of chronic -1 infection.
  • Evidence of active -virus (HBV) infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (= HBV antigen or viral load negative and positive HBV surface antibody).
  • Evidence of active infection (HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry).
  • Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease.
  • Current cancer.
  • History of HIV-related thrombocytopenia.
  • Pregnancy or breastfeeding.
  • Any condition, including preexisting psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant.
  • Abnormal results of standard of care laboratory tests:

    1. Confirmed \<11g/dl for women and \<12 g/dl for men
    2. Confirmed count \<100 000/µl *
    3. Confirmed \<1000/μl
    4. Confirmed (AST) and/or alanine aminotransferase (ALT)>10x (ULN)
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Immuno-virological evaluation of persons living with HIV

    Leucapheresis will be performed in HIV positive people making white blood cells available for in depth virological and immunological evaluation

    Procedure: Leucapheresis

Interventions

  • ProcedureLeucapheresis

    leucapheresis is a procedure in which a large amount of blood cells are obtained by an apheresis procedure

06

What researchers measure

Primary outcomes

  1. Information on virological aspects of people on long term ART versus people treated during recent infection

    Intact proviral deoxyribonucleic acid (DNA) assay quantified by digital Polymerase Chain Reaction (pcr)

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05973825
Collaborators
Vrije Universiteit Brussel, Centre Hospitalier Universitaire Saint Pierre, Centre Hospitalier Universitaire de Liege, Universitair Ziekenhuis Brussel, Université Libre de Bruxelles, KU Leuven
Responsible party
Sponsor
First posted
Aug 3, 2023
Start date
Feb 13, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Linos Vandekerckhove
Contact
linos.vandekerckhove@ugent.be
+3293323398
Linos vandekerckhove
principal investigator · UZ Gent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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