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

A Phase 1b, Randomized, Blinded, Placebo-Controlled Dose-Escalation Study of the Safety and Biological Activity of GS-9620 in HIV-1 Infected, Virologically Suppressed Adults

The primary objectives of this study are to evaluate the safety and tolerability of escalating, multiple doses of vesatolimod (formerly GS-9620) in HIV-1 infected virologically suppressed adults on antiretroviral therapy (ART) and to evaluate the virologic effect of vesatolimod as measured by changes in plasma HIV-1 RNA.

Key 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

Key Exclusion Criteria:

• Hepatitis B surface antigen (HBsAg) positive

  • Positive anti-HBs antibody and negative HBsAg results are acceptable

• Hepatitis C antibody (HCVAb) positive

  • Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable

• Documented history of pre-ART CD4 nadir < 200 cells/µL

  • Unknown pre-ART CD4 nadir is acceptable

• A new AIDS-defining condition diagnosed within 90 days prior to screening

• Acute febrile illness within 35 days prior to pre-baseline/Day -13

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