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

Prior treatment

• 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.

Other illness

• 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.

Lab values

• 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)

Other

• Pregnancy or breastfeeding.

• 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).