Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults

Inclusion Criteria

• •HIV-1 infection
• •Aged ≥ 18 years at Pre-baseline/Day -13
• •On antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to Pre-Baseline/Day -13
• •* The following agents are allowed as part of the current ARV regimen: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc
• •* The following agents are NOT allowed as part of the current ARV regimen: HIV protease inhibitors (including low dose ritonavir), cobicistat-containing regimens, elvitegravir, efavirenz, etravirine, and nevirapine
• •* A change in ARV regimen ≥ 45 days prior to baseline/Day 1 for reasons other than virologic failure (eg, tolerability, simplification, drug-drug interaction profile) is allowed
• •Plasma HIV-1 RNA \< 50 copies/mL at screening
• •Documented plasma HIV-1 RNA levels \< 50 copies/mL (according to the local assay being used) for ≥ 12 months preceding the screening visit (measured at least twice using a licensed assay with a lower limit of quantitation of at least 40 copies/mL)
• •* Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. (If the lower limit of detection of the local HIV-1 RNA assay is \< 50 copies/mL, the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests)
• •* If ART regimen is changed ≥ 60 days prior to Pre-Baseline/Day -13, plasma HIV-1 RNA \<50 copies/mL at Pre-baseline/Day -13 visit is required
• •No documented history of resistance to any components of the current ARV regimen
• •Availability of a fully active alternative ARV regimen, in the opinion of the Investigator, in the event of discontinuation of the current ARV regimen with development of resistance
• •Hgb ≥ 11.5 g/dL (males) or ≥ 11 g/dL (females)
• •White blood cells (WBC) ≥ 4,000 cells/μL
• •Platelets ≥ 150,000/mL
• •Absolute neutrophil count (ANC) ≥ 1500 cells/μL
• •CD4 count ≥ 400 cells/μL
• •Albumin ≥ 3.9 g/dL
• •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of the normal range (ULN)
• •Estimated glomerular filtration rate ≥ 60 mL/min
• •No autoimmune disease