HIV-1-infectionNCT05973825
Immuno-virological Evaluation of Persons Living With HIV (PLWH)
A study testing Leucapheresis in people with HIV-1-infection and HIV Seropositivity, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV-1-infection, HIV Seropositivity
- What is being tested?
- Leucapheresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Feb 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort 1: short-term ART cohort
- Documented HIV-1 infection
- Able and willing to provide written informed consent
- 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
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- 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).
Who cannot join
- 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 HIV-1 infection.
- Evidence of active Hepatitis B-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 HCV 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.
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- 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:
- Confirmed haemoglobin <11g/dl for women and <12 g/dl for men
- Confirmed platelet count <100 000/µl *
- Confirmed neutrophil count <1000/μl
- Confirmed Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>10x upper limit of normal (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Gent
Ghent, Oost-Vlaanderen, 9000
Linos Vandekerckhove, 09333398, linos.vandekerckhove@ugent.be
About this study
Official title: 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
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.
- Conditions
- HIV-1-infection, HIV Seropositivity
- Being tested
- Leucapheresis
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeucapheresisProcedure or surgery
leucapheresis is a procedure in which a large amount of blood cells are obtained by an apheresis procedure
| Study group | Role | What they receive |
|---|---|---|
| Immuno-virological evaluation of persons living with HIV | Experimental | Leucapheresis will be performed in HIV positive people making white blood cells available for in depth virological and immunological evaluation Receives: Procedure: Leucapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start13 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Linos vandekerckhove, Principal investigator, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973825
- Sponsor's protocol ID
- ONZ-2023-0154
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05973825
- Acronym / sponsor ID
- ONZ-2023-0154
- Conditions
- HIV-1-infection, HIV Seropositivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Centre Hospitalier Universitaire Saint Pierre, Centre Hospitalier Universitaire de Liege, Universitair Ziekenhuis Brussel, Université Libre de Bruxelles, KU Leuven
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immuno-virological evaluation of persons living with HIV | Experimental | Procedure: LeucapheresisLeucapheresis will be performed in HIV positive people making white blood cells available for in depth virological and immunological evaluation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Cohort 1: short-term ART cohort
- Documented HIV-1 infection
- Able and willing to provide written informed consent
- Age = or >18 years and < 80 years
- ART started during a documented recent HIV-1 infection (acute HIV infection, defined as:
Key exclusion criteria (15 listed)
- 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 HIV-1 infection.
- Evidence of active Hepatitis B-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 HCV 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leucapheresisleucapheresis is a procedure in which a large amount of blood cells are obtained by an apheresis procedure | Procedure or surgery | Immuno-virological evaluation of persons living with HIV |
Primary outcome
Information on virological aspects of people on long term ART versus people treated during recent infection
Time frame: 3 years
Intact proviral deoxyribonucleic acid (DNA) assay quantified by digital Polymerase Chain Reaction (pcr)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linos vandekerckhove principal investigator
UZ Gent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leucapheresis in people with HIV-1-infection and HIV Seropositivity, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linos Vandekerckhove (+3293323398, linos.vandekerckhove@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information on virological aspects of people on long term ART versus people treated during recent infection (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.