HIV cure clue: does early treatment shrink the hidden virus?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.