Study to Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated Human Immunodeficiency Virus (HIV-1) Infected Controllers

A Phase 1b, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of GS-9620 in Antiretroviral Treated HIV-1 Infected Controllers

The primary objective of this study is to evaluate the safety and tolerability of a 10-dose regimen of vesatolimod in HIV-1 infected controllers on antiretroviral treatment (ART) and during analytical treatment interruption (ATI) following vesatolimod dosing.

Key Inclusion Criteria:

• Plasma HIV-1 ribonucleic acid (RNA) levels < 50 copies/mL at screening
• 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.