Chronic HIV-1 infection (for ≥ 6 months) prior to ART initiation
Pre-ART Plasma HIV-1 RNA set point between 50 and ≤ 5,000 copies/mL measured within two years prior to ART initiation
On ART for ≥ 6 consecutive months prior to screening
Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 6 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable.
No documented history of resistance to any components of the current ART regimen
Availability of a fully active alternative ART regimen, in the opinion of the Investigator, in the event of discontinuation of the current ART regimen with development of resistance.
Hemoglobin ≥ 11.5 g/dL (males) or ≥ 11 g/dL (females)
White Blood Cells ≥ 2,500 cells/μL
Platelets ≥ 125,000/mL
Absolute Neutrophil Counts ≥ 1000 cells/μL
Cluster of Differentiation 4 (CD4)+ count ≥ 500 cells/μL
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or bilirubin ≤ 2 × upper limit of normal (ULN)
Estimated glomerular filtration rate ≥ 60 mL/min
No autoimmune disease requiring on-going immunosuppression
No evidence of current hepatitis B virus (HBV) infection
No evidence of current hepatitis C virus (HCV) infection (positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable)
No documented history of pre-ART CD4 nadir \< 200 cells/μL (unknown pre-ART CD4 nadir is acceptable)
No history of opportunistic illness indicative of stage 3 HIV
No acute febrile illness within 35 days prior to Pre-Baseline/ Day -13
Clareo Health | Study to Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated Human Immunodeficiency Virus (HIV-1) Infected Controllers
