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

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.