Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults
Condition: HIV-1 Infection
Intervention: Vesatolimod; Placebo; ARV regimen
Intervention description: Tablet(s) administered orally once every 2 weeks; Tablet(s) administered orally once every 2 weeks; Participants' current ARV regimen must be used in accordance with their prescribing information and may include the following: nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), raltegravir, dolutegravir, rilpivirine, and maraviroc.
Intervention MeSH terms: Vesatolimod
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.