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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02858401
Recruitment Status : Completed
First Posted : August 8, 2016
Results First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: Vesatolimod
Drug: Placebo
Drug: ARV regimen
Enrollment 48
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 Details 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
Hide 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
Reason Not Completed
Withdrew Consent             0             0             0             0             0             1             0
Lost to Follow-up             0             1             0             0             0             0             0
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
Hide 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 Number of Baseline Participants 6 6 6 6 6 6 12 48
Hide Baseline Analysis Population Description
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
Female 0 1 0 0 3 1 0 5
Male 6 5 6 6 3 5 12 43
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
Hispanic or Latino 1 2 0 0 2 0 0 5
Not Hispanic or Latino 5 4 6 6 4 6 12 43
Unknown or Not Reported 0 0 0 0 0 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
Black 0 0 0 1 1 0 0 2
White 6 6 6 5 5 6 12 46
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
< 50 copies/ mL 6 6 6 6 6 6 12 48
≥ 50 copies/ mL 0 0 0 0 0 0 0 0
1.Primary Outcome
Title Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs).
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 6 6 6 6 6 12
Measure Type: Number
Unit of Measure: percentage of participants
SAEs 0.0 16.7 0.0 0.0 0.0 0.0 0.0
AEs 66.7 66.7 33.3 66.7 83.3 66.7 75.0
2.Primary Outcome
Title Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 6 6 6 6 6 12
Mean (Standard Error)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1498
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0640
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2807
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1228
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0289
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5895
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 0 0 0 6 6 6 5
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
0.00  (0.000) 0.00  (0.000) 0.00  (0.000) 0.00  (0.000)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 6 6 6 5 6 12
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5557
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5557
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8288
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5557
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6056
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5557
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 6 6 0 0 0 6
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
0.00  (0.000) 0.00  (0.000) -0.03  (0.062) 0.00  (0.000)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4047
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 6 5 6 6 6 12
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1556
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 6 5 0 0 0 6
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
0.00  (0.000) 0.00  (0.000) -0.03  (0.068) 0.00  (0.000)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3613
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 5 6 6 6 6 6 12
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1949
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 6 6 0 0 0 6
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
0.00  (0.000) 0.00  (0.000) 0.01  (0.117) 0.00  (0.000)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 6 6 0 0 0 6
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
0.00  (0.000) 0.00  (0.000) -0.03  (0.062) 0.00  (0.000)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4047
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 6 5 6 6 6 12
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1556
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 6 6 0 0 0 6
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
0.00  (0.000) 0.00  (0.000) -0.03  (0.062) 0.00  (0.000)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4047
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 6 6 6 6 12
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1949
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4278
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 6 0 6 6 10
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5186
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5716
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1869
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5186
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5186
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 6 0 0 0 5
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
0.00  (0.000) 0.00  (0.000) -0.03  (0.062) 0.01  (0.028)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3613
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4237
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2230
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 6 6 6 6 12
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3456
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3971
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1301
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3456
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3456
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3456
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 6 0 0 0 6
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
0.00  (0.000) 0.00  (0.000) 0.04  (0.190) 0.25  (0.620)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4047
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4652
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5993
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 6 6 6 6 12
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1949
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 6 0 6 6 9
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2763
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 5 0 0 0 6
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
0.00  (0.000) 0.00  (0.000) 0.07  (0.249) 0.00  (0.000)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 6 6 6 6 12
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1949
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 6 0 0 0 6
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
0.00  (0.000) 0.00  (0.000) 0.01  (0.126) 0.00  (0.000)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 6 6 6 6 11
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5383
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5896
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8207
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5383
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5383
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5383
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 0 0 0 6 6 6 5
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
0.00  (0.000) 0.00  (0.000) 0.00  (0.000) 0.00  (0.000)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 6 6 6 6 11
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3237
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3755
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4577
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3237
Comments [Not Specified]
Method Wilcoxon rank sum test
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Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
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Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3237
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
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Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3237
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61
Hide 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
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Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 6 0 0 0 6
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
0.00  (0.000) 0.00  (0.000) 0.01  (0.126) 0.03  (0.081)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
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Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4047
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4652
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
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Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7526
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
27.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64
Hide 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
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Hide 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
Hide 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).
Overall Number of Participants Analyzed 5 5 6 6 6 6 11
Mean (Standard Deviation)
Unit of Measure: 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)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod 1 mg (Cohort 1), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5546
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod 2 mg (Cohort 2), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6937
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod 4 mg (Cohort 3), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8207
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod 6 mg (Cohort 4), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5383
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod 8 mg (Cohort 5), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5383
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod 10 or 12 mg (Cohort 6), Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7878
Comments [Not Specified]
Method Wilcoxon rank sum test
Comments [Not Specified]
28.Secondary Outcome
Title Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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).
Overall Number of Participants Analyzed 6 5 6 0 0 0 6
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
0.00  (0.000) 0.00  (0.000) 0.04  (0.194) 0.00  (0.000)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection