Study to Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated Human Immunodeficiency Virus (HIV-1) Infected Controllers
Condition: HIV-1 Infection
Intervention: Vesatolimod; Placebo; ART
Intervention description: Tablets Administered orally; Tablets Administered orally; ART regimens administered in accordance with their prescribing information. The following agents are allowed as part of the ART regimen: nucleoside reverse transcriptase inhibitors, raltegravir, dolutegravir (DTG), 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: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.