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

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02858401
Collaborator
(none)
48
Enrollment
8
Locations
10
Arms
48.5
Actual Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jan 29, 2015
Actual Primary Completion Date :
Feb 14, 2019
Actual Study Completion Date :
Feb 14, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vesatolimod 1 mg (Cohort 1)

Vesatolimod 1 mg for 71 days, while continuing their existing ARV regimen

Drug: Vesatolimod
Tablet(s) administered orally once every 2 weeks
Other Names:
  • GS-9620

    • Drug: ARV regimen
    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.
    Experimental: Vesatolimod 2 mg (Cohort 2)

    Vesatolimod 2 mg for 71 days, while continuing their existing ARV regimen

    Drug: Vesatolimod
    Tablet(s) administered orally once every 2 weeks
    Other Names:
  • GS-9620

    • Drug: ARV regimen
    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.
    Experimental: Vesatolimod 4 mg (Cohort 3)

    Vesatolimod 4 mg for 71 days, while continuing their existing ARV regimen

    Drug: Vesatolimod
    Tablet(s) administered orally once every 2 weeks
    Other Names:
  • GS-9620

    • Drug: ARV regimen
    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.
    Experimental: Vesatolimod 6 mg (Cohort 4)

    Vesatolimod 6 mg for 127 days, while continuing their existing ARV regimen

    Drug: Vesatolimod
    Tablet(s) administered orally once every 2 weeks
    Other Names:
  • GS-9620

    • Drug: ARV regimen
    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.
    Experimental: Vesatolimod 8 mg (Cohort 5)

    Vesatolimod 8 mg for 127 days administered following overnight fasting, while continuing their existing ARV regimen

    Drug: Vesatolimod
    Tablet(s) administered orally once every 2 weeks
    Other Names:
  • GS-9620

    • Drug: ARV regimen
    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.
    Experimental: Vesatolimod 10 or 12 mg (Cohort 6)

    Vesatolimod 10 or 12 mg for 127 days administered following overnight fasting, while continuing their existing ARV regimen. Participants will receive 3 administrations of 10 mg, followed by 7 administrations of 12 mg (after review of 10 mg safety data)

    Drug: Vesatolimod
    Tablet(s) administered orally once every 2 weeks
    Other Names:
  • GS-9620

    • Drug: ARV regimen
    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.
    Experimental: Vesatolimod 12 mg (Optional Cohort 7)

    Vesatolimod up to 12 mg for up to 127 days for up to 10 total doses administered following overnight fasting, while continuing their existing ARV regimen

    Drug: Vesatolimod
    Tablet(s) administered orally once every 2 weeks
    Other Names:
  • GS-9620

    • Drug: ARV regimen
    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.
    Experimental: Vesatolimod 6 mg with an acidic solution (Optional Cohort 8)

    Vesatolimod 6 mg for 127 days for up to 10 total doses administered with an acidic solution (cranberry juice), while continuing their existing ARV regimen

    Drug: Vesatolimod
    Tablet(s) administered orally once every 2 weeks
    Other Names:
  • GS-9620

    • Drug: ARV regimen
    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.
    Experimental: Vesatolimod up to 12 mg (Cohort 9)

    Vesatolimod up to 12 mg for 127 days for up to 10 total doses administered following a moderate-fat meal, after the review of the data from the highest tolerated fasted dose cohort while continuing their existing ARV regimen

    Drug: Vesatolimod
    Tablet(s) administered orally once every 2 weeks
    Other Names:
  • GS-9620

    • Drug: ARV regimen
    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.
    Placebo Comparator: Placebo (Cohorts 1-9)

    Placebo to match vesatolimod for 71 or 127 days, while continuing their existing ARV regimen

    Drug: Placebo
    Tablet(s) administered orally once every 2 weeks

    Drug: ARV regimen
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). [For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days]

    2. Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint [For Cohorts 1 to 3: Baseline to Day 81; For Cohorts 4 to 6: Baseline to Day 134; For placebo: Baseline to Day 81 or Baseline to Day 134]

      The maximum change from baseline in plasma Log10 HIV-1 RNA refers to the maximum change at any postdose timepoint up to Day 81 or Day 134 for placebo, Day 81 for Cohorts 1 to 3, and Day 134 for Cohorts 4 to 6.

    Secondary Outcome Measures

    1. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2 [Baseline; Day 2]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 2.

    2. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3 [Baseline; Day 3]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 3.

    3. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5 [Baseline; Day 5]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 5.

    4. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8 [Baseline; Day 8]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 8.

    5. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11 [Baseline; Day 11]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 11.

    6. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15 [Baseline; Day 15]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 15.

    7. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17 [Baseline; Day 17]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 17.

    8. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19 [Baseline; Day 19]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 19.

    9. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22 [Baseline; Day 22]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 22.

    10. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25 [Baseline; Day 25]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 25.

    11. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29 [Baseline; Day 29]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 29.

    12. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31 [Baseline; Day 31]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 31.

    13. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33 [Baseline; Day 33]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 33.

    14. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36 [Baseline; Day 36]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 36

    15. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39 [Baseline; Day 39]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 39

    16. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43 [Baseline; Day 43]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 43

    17. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45 [Baseline; Day 45]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit pn Day 45

    18. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47 [Baseline; Day 47]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 47

    19. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50 [Baseline; Day 50]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 50.

    20. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53 [Baseline; Day 53]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 53

    21. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57 [Baseline; Day 57]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 57.

    22. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58 [Baseline; Day 58]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 58.

    23. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59 [Baseline; Day 59]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 59.

    24. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61 [Baseline; Day 61]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 61.

    25. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64 [Baseline; Day 64]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 64.

    26. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67 [Baseline; Day 67]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 67.

    27. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71 [Baseline; Day 71]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 71.

    28. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73 [Baseline; Day 73]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 73.

    29. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 75 [Baseline; Day 75]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 75.

    30. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78 [Baseline; Day 78]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 78.

    31. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 81 [Baseline; Day 81]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 81.

    32. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 85 [Baseline; Day 85]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 85.

    33. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 87 [Baseline; Day 87]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 87.

    34. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 92 [Baseline; Day 92]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 92.

    35. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 99 [Baseline; Day 99]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 99.

    36. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101 [Baseline; Day 101]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 101.

    37. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 106 [Baseline; Day 106]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 106.

    38. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 113 [Baseline; Day 113]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 113.

    39. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 115 [Baseline; Day 115]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 115.

    40. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 120 [Baseline; Day 120]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 120.

    41. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 127 [Baseline; Day 127]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 127.

    42. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 128 [Baseline; Day 128]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 128.

    43. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 129 [Baseline; Day 129]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 129.

    44. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 134 [Baseline; Day 134]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 134.

    45. Change From Baseline in Plasma Log10 HIV-1 RNA at Day 157 [Baseline; Day 157]

      Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 157.

    46. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1 [Postdose 1 on Day 1]

    47. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15 [PostDose 2 on Day 15]

    48. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29 [PostDose 3 on Day 29]

    49. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43 [PostDose 4 on Day 43]

    50. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57 [PostDose 5 on Day 57]

    51. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71 [PostDose 6 on Day 71]

    52. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85 [PostDose 7 on Day 85]

    53. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99 [PostDose 8 on Day 99]

    54. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113 [PostDose 9 on Day 113]

    55. Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127 [PostDose 10 on Day 127]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mills Clinical Research Los Angeles California United States 90069
    2 UCSD Antiviral Research Center (AVRC) San Diego California United States 92103
    3 Midway Immunology & Research Center Fort Pierce Florida United States 34982
    4 Orlando Immunology Center Recruiting Orlando Florida United States 32803
    5 Ohio State University Infectious Diseases Research Columbus Ohio United States 43210
    6 University of Pittsburgh Pittsburgh Pennsylvania United States 15213
    7 Central Texas Clinical Research Austin Texas United States 78705
    8 Peter Shalit, MD Seattle Washington United States 98104

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02858401
    Other Study ID Numbers:
    • GS-US-382-1450
    First Posted:
    Aug 8, 2016
    Last Update Posted:
    Feb 21, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vesatolimod

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in United States. The first participant was screened on 29 January 2015. The last study visit occurred on 14 February 2019.
    Pre-assignment Detail 58 participants were screened.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing antiretroviral (ARV) regimen in accordance with their prescribing information (the following agents were allowed: nucleoside/nucleotide reverse transcriptase inhibitors [NRTIs], raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to Day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Period Title: Overall Study
    STARTED 6 6 6 6 6 6 12
    COMPLETED 6 5 6 6 6 5 12
    NOT COMPLETED 0 1 0 0 0 1 0

    Baseline Characteristics

    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo Total
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Total of all reporting groups
    Overall Participants 6 6 6 6 6 6 12 48
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    44
    (11.0)
    45
    (10.7)
    52
    (4.8)
    44
    (9.3)
    45
    (9.9)
    47
    (17.5)
    45
    (11.9)
    46
    (10.9)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    3
    50%
    1
    16.7%
    0
    0%
    5
    10.4%
    Male
    6
    100%
    5
    83.3%
    6
    100%
    6
    100%
    3
    50%
    5
    83.3%
    12
    100%
    43
    89.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    16.7%
    2
    33.3%
    0
    0%
    0
    0%
    2
    33.3%
    0
    0%
    0
    0%
    5
    10.4%
    Not Hispanic or Latino
    5
    83.3%
    4
    66.7%
    6
    100%
    6
    100%
    4
    66.7%
    6
    100%
    12
    100%
    43
    89.6%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Black
    0
    0%
    0
    0%
    0
    0%
    1
    16.7%
    1
    16.7%
    0
    0%
    0
    0%
    2
    4.2%
    White
    6
    100%
    6
    100%
    6
    100%
    5
    83.3%
    5
    83.3%
    6
    100%
    12
    100%
    46
    95.8%
    HIV-1 RNA (log10 copies/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 copies/mL]
    1.28
    (0.000)
    1.28
    (0.000)
    1.30
    (0.062)
    1.28
    (0.000)
    1.28
    (0.000)
    1.28
    (0.000)
    1.28
    (0.000)
    1.28
    (0.022)
    HIV-1 RNA Category (Count of Participants)
    < 50 copies/ mL
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    12
    100%
    48
    100%
    ≥ 50 copies/ mL
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs).
    Description
    Time Frame For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days

    Outcome Measure Data

    Analysis Population Description
    The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 6 6 6 6 6 12
    SAEs
    0.0
    0%
    16.7
    278.3%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    AEs
    66.7
    1111.7%
    66.7
    1111.7%
    33.3
    555%
    66.7
    1111.7%
    83.3
    1388.3%
    66.7
    1111.7%
    75.0
    625%
    2. Primary Outcome
    Title Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint
    Description The maximum change from baseline in plasma Log10 HIV-1 RNA refers to the maximum change at any postdose timepoint up to Day 81 or Day 134 for placebo, Day 81 for Cohorts 1 to 3, and Day 134 for Cohorts 4 to 6.
    Time Frame For Cohorts 1 to 3: Baseline to Day 81; For Cohorts 4 to 6: Baseline to Day 134; For placebo: Baseline to Day 81 or Baseline to Day 134

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 6 6 6 6 6 12
    Mean (Standard Error) [Log10 copies/mL]
    0.06
    (0.141)
    0.01
    (0.018)
    0.10
    (0.252)
    0.04
    (0.092)
    0.00
    (0.000)
    0.07
    (0.073)
    0.42
    (0.729)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1498
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0640
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2807
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1228
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0289
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5895
    Comments
    Method Wilcoxon rank sum test
    Comments
    3. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 2.
    Time Frame Baseline; Day 2

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 6 5
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    4. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 3.
    Time Frame Baseline; Day 3

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 6 6 6 5 6 12
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.091)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.01
    (0.034)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5557
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5557
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8288
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5557
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6056
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5557
    Comments
    Method Wilcoxon rank sum test
    Comments
    5. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 5.
    Time Frame Baseline; Day 5

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 6 6 0 0 0 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.062)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    6. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 8.
    Time Frame Baseline; Day 8

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 6 5 6 6 6 12
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.068)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1556
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    7. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 11.
    Time Frame Baseline; Day 11

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 6 5 0 0 0 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.068)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3613
    Comments
    Method Wilcoxon rank sum test
    Comments
    8. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 15.
    Time Frame Baseline; Day 15

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 5 6 6 6 6 6 12
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.062)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1949
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    9. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 17.
    Time Frame Baseline; Day 17

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 6 6 0 0 0 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.01
    (0.117)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    10. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 19.
    Time Frame Baseline; Day 19

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg tablet orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg tablet orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg tablet orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg tablet orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg tablet following overnight fasting once every 2 weeks for 127 days for a total of 10 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg up to Day 43 for a total of 3 doses then vesatolimod 12 mg up to 12 mg for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 6 6 0 0 0 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.062)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    11. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 22.
    Time Frame Baseline; Day 22

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 6 5 6 6 6 12
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.02
    (0.037)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1556
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    12. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 25.
    Time Frame Baseline; Day 25

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 6 6 0 0 0 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.062)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    13. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 29.
    Time Frame Baseline; Day 29

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 6 6 6 12
    Mean (Standard Deviation) [Log10 copies/mL]
    0.01
    (0.018)
    0.00
    (0.000)
    0.02
    (0.112)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1949
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4278
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    14. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 31.
    Time Frame Baseline; Day 31

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 0 6 6 10
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.062)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.014)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5186
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5716
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1869
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5186
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5186
    Comments
    Method Wilcoxon rank sum test
    Comments
    15. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 33.
    Time Frame Baseline; Day 33

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 0 0 0 5
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.062)
    0.01
    (0.028)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3613
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4237
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2230
    Comments
    Method Wilcoxon rank sum test
    Comments
    16. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 36
    Time Frame Baseline; Day 36

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 6 6 6 12
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.062)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.16
    (0.500)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3456
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3971
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1301
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3456
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3456
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3456
    Comments
    Method Wilcoxon rank sum test
    Comments
    17. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 39
    Time Frame Baseline; Day 39

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 0 0 0 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.04
    (0.190)
    0.25
    (0.620)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4652
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5993
    Comments
    Method Wilcoxon rank sum test
    Comments
    18. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 43
    Time Frame Baseline; Day 43

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 6 6 6 12
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.062)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1949
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    19. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit pn Day 45
    Time Frame Baseline; Day 45

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 0 6 6 9
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.062)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2763
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    20. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 47
    Time Frame Baseline; Day 47

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 5 0 0 0 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.07
    (0.249)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    21. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 50.
    Time Frame Baseline; Day 50

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 6 6 6 12
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.062)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1949
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    22. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 53
    Time Frame Baseline; Day 53

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 0 0 0 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.01
    (0.126)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    23. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 57.
    Time Frame Baseline; Day 57

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 6 6 6 11
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.03
    (0.165)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.03
    (0.097)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5383
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5896
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8207
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5383
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5383
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5383
    Comments
    Method Wilcoxon rank sum test
    Comments
    24. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 58.
    Time Frame Baseline; Day 58

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 6 5
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    25. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 59.
    Time Frame Baseline; Day 59

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 6 6 6 11
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.01
    (0.081)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.07
    (0.190)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3237
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3755
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4577
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3237
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3237
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3237
    Comments
    Method Wilcoxon rank sum test
    Comments
    26. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 61.
    Time Frame Baseline; Day 61

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 0 0 0 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.01
    (0.126)
    0.03
    (0.081)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4652
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7526
    Comments
    Method Wilcoxon rank sum test
    Comments
    27. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 64.
    Time Frame Baseline; Day 64

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 5 5 6 6 6 6 11
    Mean (Standard Deviation) [Log10 copies/mL]
    0.07
    (0.154)
    0.01
    (0.019)
    0.07
    (0.249)
    0.00
    (0.000)
    0.00
    (0.000)
    0.02
    (0.041)
    0.02
    (0.072)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5546
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6937
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8207
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5383
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5383
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7878
    Comments
    Method Wilcoxon rank sum test
    Comments
    28. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 67.
    Time Frame Baseline; Day 67

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 0 0 0 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.04
    (0.194)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    29. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 71.
    Time Frame Baseline; Day 71

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 6 6 6 12
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.02
    (0.140)
    0.00
    (0.000)
    0.00
    (0.000)
    0.02
    (0.056)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1949
    Comments
    Method Wilcoxon rank sum test
    Comments
    30. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 73.
    Time Frame Baseline; Day 73

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 0 6 6 10
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.01
    (0.112)
    0.00
    (0.000)
    0.00
    (0.000)
    0.04
    (0.136)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5186
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5716
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6908
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5186
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5186
    Comments
    Method Wilcoxon rank sum test
    Comments
    31. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 75
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 75.
    Time Frame Baseline; Day 75

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 0 0 0 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.062)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    32. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 78.
    Time Frame Baseline; Day 78

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 6 6 6 11
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.062)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.19
    (0.635)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5383
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5896
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1784
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5383
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5383
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5383
    Comments
    Method Wilcoxon rank sum test
    Comments
    33. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 81
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 81.
    Time Frame Baseline; Day 81

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 5 0 0 0 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    -0.03
    (0.071)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    34. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 85
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 85.
    Time Frame Baseline; Day 85

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 6 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.03
    (0.075)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    35. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 87
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 87.
    Time Frame Baseline; Day 87

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 0 6 6 4
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.19
    (0.385)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3074
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3074
    Comments
    Method Wilcoxon rank sum test
    Comments
    36. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 92
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 92.
    Time Frame Baseline; Day 92

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 6 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.11
    (0.261)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    37. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 99
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 99.
    Time Frame Baseline; Day 99

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 6 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.03
    (0.062)
    0.07
    (0.142)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1757
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1757
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5993
    Comments
    Method Wilcoxon rank sum test
    Comments
    38. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 101.
    Time Frame Baseline; Day 101

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 0 6 6 10
    Mean (Standard Deviation) [Log10 copies/mL]
    0.02
    (0.049)
    0.00
    (0.000)
    0.00
    (0.102)
    0.00
    (0.000)
    0.00
    (0.000)
    0.05
    (0.173)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8504
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5716
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6908
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5186
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5186
    Comments
    Method Wilcoxon rank sum test
    Comments
    39. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 106
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 106.
    Time Frame Baseline; Day 106

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 6 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.10
    (0.250)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    40. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 113
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 113.
    Time Frame Baseline; Day 113

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 6 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.09
    (0.218)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    41. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 115
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 115.
    Time Frame Baseline; Day 115

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 0 6 6 4
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.08
    (0.156)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3074
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3074
    Comments
    Method Wilcoxon rank sum test
    Comments
    42. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 120
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 120.
    Time Frame Baseline; Day 120

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 6 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.04
    (0.092)
    0.00
    (0.000)
    0.00
    (0.000)
    0.01
    (0.018)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    43. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 127
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 127.
    Time Frame Baseline; Day 127

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 5 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Wilcoxon rank sum test
    Comments
    44. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 128
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 128.
    Time Frame Baseline; Day 128

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 5 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.06
    (0.129)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1757
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1757
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2230
    Comments
    Method Wilcoxon rank sum test
    Comments
    45. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 129
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 129.
    Time Frame Baseline; Day 129

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 5 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.03
    (0.062)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4652
    Comments
    Method Wilcoxon rank sum test
    Comments
    46. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 134
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 134.
    Time Frame Baseline; Day 134

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 5 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.09
    (0.215)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4047
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4652
    Comments
    Method Wilcoxon rank sum test
    Comments
    47. Secondary Outcome
    Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 157
    Description Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 157.
    Time Frame Baseline; Day 157

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 5 6
    Mean (Standard Deviation) [Log10 copies/mL]
    0.00
    (0.000)
    0.00
    (0.000)
    0.00
    (0.000)
    0.13
    (0.254)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1757
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1757
    Comments
    Method Wilcoxon rank sum test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2230
    Comments
    Method Wilcoxon rank sum test
    Comments
    48. Secondary Outcome
    Title Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1
    Description
    Time Frame Postdose 1 on Day 1

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 6 6 6 6 6 12
    Number [percentage of participants]
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    49. Secondary Outcome
    Title Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15
    Description
    Time Frame PostDose 2 on Day 15

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 6 6 5 6 6 12
    Number [percentage of participants]
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    50. Secondary Outcome
    Title Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29
    Description
    Time Frame PostDose 3 on Day 29

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 6 6 6 12
    Number [percentage of participants]
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    8.3
    69.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    51. Secondary Outcome
    Title Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43
    Description
    Time Frame PostDose 4 on Day 43

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 6 6 6 12
    Number [percentage of participants]
    0.0
    0%
    0.0
    0%
    16.7
    278.3%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3333
    Comments
    Method Fisher Exact
    Comments
    52. Secondary Outcome
    Title Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57
    Description
    Time Frame PostDose 5 on Day 57

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 6 6 6 11
    Number [percentage of participants]
    0.0
    0%
    0.0
    0%
    16.7
    278.3%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    9.1
    75.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    53. Secondary Outcome
    Title Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71
    Description
    Time Frame PostDose 6 on Day 71

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 6 5 6 5 6 6 11
    Number [percentage of participants]
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    9.1
    75.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    54. Secondary Outcome
    Title Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85
    Description
    Time Frame PostDose 7 on Day 85

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 6 6
    Number [percentage of participants]
    0.0
    0%
    0.0
    0%
    0.0
    0%
    16.7
    278.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    55. Secondary Outcome
    Title Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99
    Description
    Time Frame PostDose 8 on Day 99

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 4 6 6 6
    Number [percentage of participants]
    0.0
    0%
    0.0
    0%
    0.0
    0%
    16.7
    278.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    56. Secondary Outcome
    Title Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113
    Description
    Time Frame PostDose 9 on Day 113

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 4 6 6 6
    Number [percentage of participants]
    0.0
    0%
    0.0
    0%
    0.0
    0%
    0.0
    0%
    57. Secondary Outcome
    Title Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127
    Description
    Time Frame PostDose 10 on Day 127

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    Measure Participants 0 0 0 6 6 5 6
    Number [percentage of participants]
    0.0
    0%
    0.0
    0%
    0.0
    0%
    16.7
    278.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 1.0000
    Comments
    Method Fisher Exact
    Comments

    Adverse Events

    Time Frame For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
    Adverse Event Reporting Description The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
    Arm/Group Title Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Arm/Group Description Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc).
    All Cause Mortality
    Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Serious Adverse Events
    Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Infections and infestations
    Diverticulitis 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Other (Not Including Serious) Adverse Events
    Vesatolimod 1 mg (Cohort 1) Vesatolimod 2 mg (Cohort 2) Vesatolimod 4 mg (Cohort 3) Vesatolimod 6 mg (Cohort 4) Vesatolimod 8 mg (Cohort 5) Vesatolimod 10 or 12 mg (Cohort 6) Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/6 (66.7%) 4/6 (66.7%) 2/6 (33.3%) 4/6 (66.7%) 5/6 (83.3%) 4/6 (66.7%) 9/12 (75%)
    Blood and lymphatic system disorders
    Lymphadenopathy 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Cardiac disorders
    Supraventricular extrasystoles 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Ear and labyrinth disorders
    Ear pain 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Tinnitus 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Vertigo 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Eye disorders
    Erythema of eyelid 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Scleral hyperaemia 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Gastrointestinal disorders
    Abdominal discomfort 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Abdominal distension 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Abdominal pain lower 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Abdominal pain upper 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Constipation 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)
    Diarrhoea 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%)
    Flatulence 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Haematochezia 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)
    Haemorrhoids 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Nausea 2/6 (33.3%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 1/12 (8.3%)
    Sensitivity of teeth 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Vomiting 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)
    General disorders
    Asthenia 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)
    Chest pain 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Chills 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)
    Early satiety 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Fatigue 2/6 (33.3%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 3/6 (50%) 3/12 (25%)
    Feeling cold 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)
    Malaise 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 1/12 (8.3%)
    Pyrexia 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/12 (0%)
    Sluggishness 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Vessel puncture site pain 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Immune system disorders
    Drug hypersensitivity 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Seasonal allergy 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)
    Infections and infestations
    Bone abscess 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)
    Conjunctivitis 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Conjunctivitis bacterial 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Gastroenteritis 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%)
    Herpes simplex 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%)
    Hordeolum 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Nasopharyngitis 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Pharyngitis 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)
    Proctitis gonococcal 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%)
    Sinusitis 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)
    Syphilis 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Tinea cruris 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Upper respiratory tract infection 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 2/6 (33.3%) 0/6 (0%) 0/12 (0%)
    Injury, poisoning and procedural complications
    Alcohol poisoning 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Contusion 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Exposure to communicable disease 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Eyelid contusion 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Skin laceration 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Sunburn 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Investigations
    Blood creatine phosphokinase increased 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Musculoskeletal stiffness 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Myalgia 0/6 (0%) 0/6 (0%) 0/6 (0%) 2/6 (33.3%) 1/6 (16.7%) 1/6 (16.7%) 1/12 (8.3%)
    Pain in jaw 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Nervous system disorders
    Disturbance in attention 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Dizziness 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)
    Dysgeusia 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Headache 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 2/12 (16.7%)
    Lethargy 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Neuropathy peripheral 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Slow speech 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Psychiatric disorders
    Abnormal dreams 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Depressed mood 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Insomnia 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)
    Renal and urinary disorders
    Haematuria 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)
    Proteinuria 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Urinary incontinence 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%)
    Reproductive system and breast disorders
    Genital lesion 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Penile pain 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Respiratory, thoracic and mediastinal disorders
    Cough 1/6 (16.7%) 0/6 (0%) 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 3/12 (25%)
    Nasal congestion 2/6 (33.3%) 1/6 (16.7%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Nasal oedema 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/12 (0%)
    Oropharyngeal pain 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Productive cough 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Rhonchi 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Sinus congestion 1/6 (16.7%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 2/12 (16.7%)
    Sneezing 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Upper-airway cough syndrome 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Skin and subcutaneous tissue disorders
    Dermatitis 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Dermatitis contact 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Dry skin 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Hyperhidrosis 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Pruritus 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Pseudofolliculitis 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Rash papular 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Rash pruritic 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Swelling face 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%)
    Surgical and medical procedures
    Tooth extraction 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/12 (8.3%)
    Vascular disorders
    Hot flush 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 1/6 (16.7%) 0/6 (0%) 0/12 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Gilead Clinical Study Information Center
    Organization Gilead Sciences
    Phone 1-833-445-3230 (GILEAD-0)
    Email GileadClinicalTrials@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02858401
    Other Study ID Numbers:
    • GS-US-382-1450
    First Posted:
    Aug 8, 2016
    Last Update Posted:
    Feb 21, 2020
    Last Verified:
    Feb 1, 2020