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

Launched by UNIVERSITY HOSPITAL, GHENT · Jul 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to learn more about the health of people living with HIV who have been on treatment for a long time. The study will include two groups of participants: one group consists of individuals who started their HIV treatment during the early stages of the infection (between 3 to 10 years ago), while the other group includes those who have been on treatment for over 20 years. Both groups must have a consistently low level of the virus in their blood and have been on their treatment without interruption.

To be eligible for the trial, participants need to be between 18 and 80 years old and should be willing to provide consent for blood samples to be collected and stored for future research. Participants can expect to have their blood drawn once and undergo a procedure called leukapheresis, which is a way to collect specific blood cells. It's important to know that certain health conditions, such as active infections or serious illnesses, may prevent someone from participating in the study. This trial is not yet recruiting, but it aims to gather important information about HIV treatment over different time periods.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • 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:
• • 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:
• • 1. Confirmed haemoglobin \<11g/dl for women and \<12 g/dl for men
• • 2. Confirmed platelet count \<100 000/µl \*
• • 3. Confirmed neutrophil count \<1000/μl
• • 4. 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.