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

Ki vehet részt

• 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)

Ki nem vehet részt

• 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 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)
• 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
• 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)
• Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease
• Current cancer
• History of HIV-related thrombocytopenia
• 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)
• Pregnancy or breastfeeding