Measuring the HIV-1 Reservoir During Cure Interventions Studies (MERCI)

Exclusion Criteria

• •Current history of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification), consisting of chronic HIV-1 infection.
• •Evidence of active 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 history of 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 AST and/or ALT \>10xULN
• •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.
• •The following treatment will be prohibited three months before screening and during the study:
• •1. immunosuppressive drugs (inclusive corticosteroids) except for drugs used for topical use.
• •2. Immunomodulatory drugs including but not limited to Granulocyte-colony stimulating factors, Granulocyte-monocyte colony-stimulating factor, interleukin 2, 7 \& 15.