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

NCT05973825 | Not Yet Recruiting

• 1 other identifier: ONZ-2023-0154
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-1-infection; HIV Seropositivity

Outcome Measures

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)

  3 years

Study Arms (1)

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

Procedure: Leucapheresis

Interventions

Leucapheresis PROCEDURE

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

Immuno-virological evaluation of persons living with HIV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• Cohort 2: long-term ART cohort
• Documented HIV-1 infection
• Able and willing to provide written informed consent

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Vrije Universiteit Brussel: collaborator
• Centre Hospitalier Universitaire Saint Pierre: collaborator
• Centre Hospitalier Universitaire de Liege: collaborator
• Universitair Ziekenhuis Brussel: collaborator
• Université Libre de Bruxelles: collaborator
• KU Leuven: collaborator

Study Sites (1)

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

HIV Seropositivity

Interventions

Leukapheresis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Linos vandekerckhove

  UZ Gent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linos Vandekerckhove

CONTACT

+3293323398; linos.vandekerckhove@ugent.be

Study Design

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

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 3, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): July 12, 2027
• Study Completion (Estimated): July 12, 2029
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

BE (1)