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Trial record 1 of 1 for:    GS-US-382-3961
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Study to Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated Human Immunodeficiency Virus (HIV-1) Infected Controllers

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: NCT03060447
Recruitment Status : Completed
First Posted : February 23, 2017
Results First Posted : April 21, 2021
Last Update Posted : April 21, 2021
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: ART
Enrollment 25
Recruitment Details Participants were enrolled at study sites in the United States. The first participant was screened on 09 May 2017. The last study visit occurred on 13 February 2020.
Pre-assignment Details 31 participants were screened.
Arm/Group Title Vesatolimod Placebo
Hide Arm/Group Description Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed antiretroviral treatment (ART). Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Period Title: Overall Study
Started 17 8
Completed 15 8
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title Vesatolimod Placebo Total
Hide Arm/Group Description Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. Total of all reporting groups
Overall Number of Baseline Participants 17 8 25
Hide Baseline Analysis Population Description
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 8 participants 25 participants
49  (11.4) 42  (9.4) 46  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 8 participants 25 participants
Female 4 0 4
Male 13 8 21
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 8 participants 25 participants
Hispanic or Latino 0 1 1
Not Hispanic or Latino 17 7 24
Unknown or Not Reported 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 8 participants 25 participants
American Indian or Alaska Native 0 0 0
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 6 2 8
White 11 6 17
More than one race 0 0 0
Unknown or Not Reported 0 0 0
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 17 participants 8 participants 25 participants
1.30  (0.108) 1.28  (0.000) 1.30  (0.089)
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 8 participants 25 participants
< 50 copies/mL 16 8 24
≥ 50 copies/mL 1 0 1
Pre-ART Plasma Viral Set-point  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 17 participants 8 participants 25 participants
3.15  (0.275) 3.08  (0.469) 3.13  (0.340)
1.Primary Outcome
Title Percentage of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events (TEAEs)
Hide Description AE was any untoward medical occurrence in a clinical study participant administered a medicinal product (MP), which did not necessarily had a causal relationship with treatment. AE was therefore any unfavorable and/or unintended sign, symptom, or disease temporally associated with use of MP, whether or not considered related to MP. TEAEs: AE with an onset date on or after the study drug start date and no later than 30 days after study drug stop date; or any AE leading to study drug discontinuation. TESAEs: event that resulted in following: death; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; medically important event or reaction: such events might not have been immediately life-threatening or resulted in death or hospitalization but may jeopardize participant or may require intervention to prevent one of the other outcomes constituting SAEs.
Time Frame From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug. Per planned analysis, this outcome measure was analyzed by vesatolimod dose level and placebo.
Arm/Group Title Vesatolimod 4 mg Vesatolimod 4/6 mg Vesatolimod 6 mg Vesatolimod 6/8 mg Vesatolimod 8 mg Placebo
Hide Arm/Group Description:
Participants in Period 1 received 10 doses of vesatolimod 4 mg tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Participants in Period 1 received 10 doses of vesatolimod 4 mg or 6 mg tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Participants in Period 1 received 10 doses of vesatolimod 6 mg tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Participants in Period 1 received 10 doses of vesatolimod 6 mg or 8 mg tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Participants in Period 1 received 10 doses of vesatolimod 8 mg tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Overall Number of Participants Analyzed 2 4 5 3 3 8
Measure Type: Number
Unit of Measure: percentage of participants
TESAEs 0 0 0 33.3 0 0
TEAEs 100.00 75.00 100.00 100.00 100.00 75.00
2.Secondary Outcome
Title Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0
Hide Description Plasma log 10 HIV-1 RNA was measured using Taqman version 2.0 assay with limit of quantification of 20 copies/mL.
Time Frame Baseline and Dose 1: Days 2,8; Dose 2: Days 1,8; Dose 3: Days 1,8; Dose 4: Days 1,2,4,8; Dose 5: Day 1,8; Dose 6: Days 1,4,8; Dose 7: Days 1,8; Dose 8: Days 1,8; Dose 9: Days 1,8; Dose 10: Days 1,2,4,8,14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set (included all participants who were randomized into the study and received at least one dose of study drug) with available data were analyzed.
Arm/Group Title Vesatolimod Placebo
Hide Arm/Group Description:
Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Overall Number of Participants Analyzed 17 8
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
Change at Dose 1: Day 2 Number Analyzed 17 participants 8 participants
-0.01  (0.027) 0.00  (0.000)
Change at Dose 1: Day 8 Number Analyzed 16 participants 8 participants
0.05  (0.212) 0.00  (0.000)
Change at Dose 2: Day 1 Number Analyzed 16 participants 8 participants
0.09  (0.372) 0.00  (0.000)
Change at Dose 2: Day 8 Number Analyzed 16 participants 8 participants
-0.03  (0.111) 0.00  (0.000)
Change at Dose 3: Day 1 Number Analyzed 16 participants 8 participants
-0.03  (0.111) 0.00  (0.000)
Change at Dose 3: Day 8 Number Analyzed 16 participants 7 participants
-0.03  (0.111) 0.00  (0.000)
Change at Dose 4: Day 1 Number Analyzed 16 participants 8 participants
-0.03  (0.111) 0.00  (0.000)
Change at Dose 4: Day 2 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 4: Day 4 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 4: Day 8 Number Analyzed 16 participants 6 participants
-0.03  (0.111) 0.00  (0.000)
Change at Dose 5: Day 1 Number Analyzed 16 participants 8 participants
-0.03  (0.111) 0.00  (0.000)
Change at Dose 5: Day 8 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 6: Day 1 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 6: Day 4 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 6: Day 8 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 7: Day 1 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 7: Day 8 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 8: Day 1 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 8: Day 8 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 9: Day 1 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 9: Day 8 Number Analyzed 14 participants 8 participants
0.00  (0.000) 0.00  (0.000)
Change at Dose 10: Day 1 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 10: Day 2 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 10: Day 4 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 10: Day 8 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Change at Dose 10: Day 14 Number Analyzed 15 participants 8 participants
-0.03  (0.115) 0.00  (0.000)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 1: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 1: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 2: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 2: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 3: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 3: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 4: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 4: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 4: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 4: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 5: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 5: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 6: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 6: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 6: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 7: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 7 - Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 8: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 8: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 9: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 9: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 10: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 10: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 10: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 10: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments Dose 10: Day 14
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
3.Secondary Outcome
Title Time to Virologic Rebound
Hide Description Time to virologic rebound was analyzed using the Kaplan-Meier method at two cut-off values; ≥ 50 copies/mL and ≥ 200 copies/mL. Virologic rebound at ≥ 50 copies/mL was defined as 2 consecutive HIV-1 RNA measurements ≥ 50 copies/mL. Virologic rebound at ≥ 200 copies/mL was defined as 2 consecutive HIV-1 RNA measurements ≥ 200 copies/mL. The date of rebound was the first time HIV-1 RNA measurement ≥ 50 copies/mL or ≥ 200 respectively.
Time Frame From Day 1 (Period 1) up to 24 weeks of Period 2 plus 6 months following virologic re-suppression on ART, an average of 17 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Vesatolimod Placebo
Hide Arm/Group Description:
Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Overall Number of Participants Analyzed 15 8
Median (Inter-Quartile Range)
Unit of Measure: weeks
≥ 50 Copies/mL
4.3
(3.1 to 6.1)
4.0
(3.0 to 4.2)
≥ 200 Copies/mL
5.1
(4.1 to 6.3)
4.1
(3.8 to 4.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ≥ 50 Copies/mL
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method Log Rank
Comments P-value between treatment groups was based on log-rank test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ≥ 200 Copies/mL
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method Log Rank
Comments P-value between treatment groups was based on log-rank test.
4.Secondary Outcome
Title Peak HIV-1 Viral Load During Period 2
Hide Description For participants who did not restart ART, the maximum value of HIV-1 RNA measurements during ATI was used as the peak value and for participants who restarted ART, the maximum value of HIV-1 RNA measurements during ATI before the restart of ART was used as the peak value.
Time Frame From Week 1 up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Vesatolimod Placebo
Hide Arm/Group Description:
Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Overall Number of Participants Analyzed 15 8
Median (Inter-Quartile Range)
Unit of Measure: Log10 copies/mL
4.21
(3.39 to 4.88)
3.97
(3.29 to 4.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values between treatment groups were based on Wilcoxon rank sum test.
5.Secondary Outcome
Title Change in Plasma Viral Load Set-Point Following ATI
Hide Description Plasma viral load set-point values were calculated at pre-ART stage and following ATI. Change in plasma viral load set-point following ATI = viral set-point following ATI minus pre-ART set point. The plasma viral set-point following ATI was calculated as the geometric mean of all the HIV-1 RNA measurements between a start date and an end date. The start date and end date was provided by clinical based on blinded individual participant's data review.
Time Frame Pre-ART (Initial Screening Visit) and 24 weeks plus 6 months following virologic re-suppression on ART (maximum 33 months and 5 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Vesatolimod Placebo
Hide Arm/Group Description:
Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Overall Number of Participants Analyzed 15 7
Median (Inter-Quartile Range)
Unit of Measure: Log10 copies/mL
-0.37
(-0.59 to -0.05)
-0.28
(-0.56 to 0.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values between treatment groups were based on Wilcoxon rank sum test.
6.Secondary Outcome
Title Change From Baseline in Levels of Serum Cytokines
Hide Description Following Serum Cytokines Levels were evaluated: interferon-a (IFN-a), interleukin-1 receptor antagonist (IL-1RA), inducible protein-10 (IP-10) and inducible T cell alpha chemoattractant (ITAC).
Time Frame Baseline and Dose 1: Day 2,8; Dose 4: Days 1,2,8; Dose 10: Days 1,2,8; ATI Remission Visit (12 weeks post ATI Visit: evaluated at maximum of 24 weeks); Early study drug discontinuation (7 days post- last ATI visit at Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Vesatolimod Placebo
Hide Arm/Group Description:
Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Overall Number of Participants Analyzed 17 8
Mean (Standard Deviation)
Unit of Measure: pg/mL
IFN-a, Baseline Number Analyzed 17 participants 8 participants
0.02  (0.036) 0.05  (0.075)
IFN-a,Change at Dose 1: Day 2 Number Analyzed 17 participants 8 participants
0.41  (0.834) -0.01  (0.073)
IFN-a,Change at Dose 1: Day 8 Number Analyzed 16 participants 8 participants
0.14  (0.447) 0.04  (0.129)
IFN-a,Change at Dose 4: Day 1 Number Analyzed 16 participants 8 participants
-0.01  (0.030) 0.10  (0.358)
IFN-a,Change at Dose 4: Day 2 Number Analyzed 16 participants 8 participants
0.75  (2.361) -0.01  (0.065)
IFN-a,Change at Dose 4: Day 8 Number Analyzed 16 participants 6 participants
0.01  (0.064) -0.03  (0.077)
IFN-a,Change at Dose 10: Day 1 Number Analyzed 15 participants 8 participants
-0.01  (0.031) -0.03  (0.056)
IFN-a,Change at Dose 10: Day 2 Number Analyzed 15 participants 8 participants
0.51  (1.028) -0.02  (0.055)
IFN-a,Change at Dose 10: Day 8 Number Analyzed 15 participants 8 participants
0.01  (0.072) -0.04  (0.065)
IFN-a,Change at ATI Remission Visit Number Analyzed 4 participants 3 participants
-0.03  (0.059) 0.17  (0.301)
IFN-a,Change at Early study drug discontinuation Number Analyzed 1 participants 0 participants
0.00
IL-1RA, Baseline Number Analyzed 15 participants 8 participants
2346.1  (3743.44) 882.9  (306.75)
IL-1RA,Change at Dose 1: Day 2 Number Analyzed 14 participants 8 participants
2797.6  (2908.21) 94.8  (190.53)
IL-1RA,Change at Dose 1: Day 8 Number Analyzed 12 participants 6 participants
-326.9  (914.43) 1004.9  (2432.36)
IL-1RA,Change at Dose 4: Day 1 Number Analyzed 13 participants 7 participants
390.4  (856.29) 42.2  (227.90)
IL-1RA,Change at Dose 4: Day 2 Number Analyzed 13 participants 7 participants
5140.4  (8692.35) 186.4  (449.94)
IL-1RA,Change at Dose 4: Day 8 Number Analyzed 14 participants 5 participants
-63.9  (1749.75) -143.5  (226.83)
IL-1RA,Change at Dose 10: Day 1 Number Analyzed 12 participants 7 participants
-160.9  (1229.91) 563.9  (1201.78)
IL-1RA,Change at Dose 10: Day 2 Number Analyzed 13 participants 8 participants
3790.2  (6401.27) 14.1  (467.90)
IL-1RA,Change at Dose 10: Day 8 Number Analyzed 12 participants 7 participants
-77.6  (521.52) -13.9  (308.80)
IL-1RA,Change at ATI Remission Visit Number Analyzed 3 participants 2 participants
-161.7  (1030.42) 491.1  (306.12)
IL-1RA,Change at Early study drug discontinuation Number Analyzed 1 participants 0 participants
222.4
IP-10, Baseline Number Analyzed 17 participants 8 participants
161.0  (82.04) 178.5  (103.50)
IP-10, Change at Dose 1: Day 2 Number Analyzed 17 participants 8 participants
554.1  (693.55) -23.9  (52.24)
IP-10,Change at Dose 1: Day 8 Number Analyzed 16 participants 8 participants
38.8  (126.82) 34.5  (182.93)
IP-10,Change at Dose 4: Day 1 Number Analyzed 16 participants 8 participants
27.8  (71.62) -25.3  (46.15)
IP-10,Change at Dose 4: Day 2 Number Analyzed 16 participants 8 participants
337.9  (487.83) -13.8  (78.10)
IP-10,Change at Dose 4: Day 8 Number Analyzed 16 participants 6 participants
23.4  (58.50) -59.0  (58.04)
IP-10,Change at Dose 10: Day 1 Number Analyzed 15 participants 8 participants
19.1  (44.13) -22.8  (54.29)
IP-10,Change at Dose 10: Day 2 Number Analyzed 15 participants 8 participants
554.6  (893.70) -17.5  (50.94)
IP-10, Change at Dose 10: Day 8 Number Analyzed 15 participants 8 participants
18.1  (82.14) -51.1  (57.23)
IP-10,Change at ATI Remission Number Analyzed 4 participants 3 participants
47.5  (48.42) 26.2  (92.41)
IP-10,Change at Early Study Drug Discontinuation Number Analyzed 1 participants 0 participants
0.7
ITAC, Baseline Number Analyzed 17 participants 8 participants
71.8  (108.10) 206.3  (329.55)
ITAC, Change at Dose 1: Day 2 Number Analyzed 17 participants 8 participants
50.4  (80.46) -13.9  (42.68)
ITAC,Change at Dose 1: Day 8 Number Analyzed 16 participants 8 participants
11.5  (34.78) -10.4  (44.02)
ITAC, Change at Dose 4: Day 1 Number Analyzed 16 participants 8 participants
8.0  (25.97) -25.4  (65.76)
ITAC,Change at Dose 4: Day 2 Number Analyzed 16 participants 8 participants
48.0  (78.14) -8.9  (33.81)
ITAC, Change at Dose 4: Day 8 Number Analyzed 16 participants 6 participants
2.0  (24.20) 5.0  (27.98)
ITAC,Change at Dose 10: Day 1 Number Analyzed 15 participants 8 participants
-1.6  (19.11) -8.4  (33.91)
ITAC,Change at Dose 10: Day 2 Number Analyzed 15 participants 8 participants
69.1  (181.55) -1.0  (27.68)
ITAC,Change at Dose 10: Day 8 Number Analyzed 15 participants 8 participants
2.2  (12.19) -7.4  (22.50)
ITAC,Change at ATI Remission Number Analyzed 4 participants 3 participants
19.1  (20.44) 39.6  (88.54)
ITAC,Change at Early Study Drug Discontinuation Number Analyzed 1 participants 0 participants
31.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IFN-a, Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IFN-a, Dose 1: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IFN-a, Dose 1: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IFN-a, Dose 4: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IFN-a, Dose 4: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IFN-a, Dose 4: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IFN-a, Dose 10: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IFN-a, Dose 10: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IFN-a, Dose 10: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IFN-a, ATI Remission Visit
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IL-1RA, Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IL-1RA, Dose 1: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IL-1RA, Dose 1: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IL-1RA, Dose 4: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Vesatolimod
Comments IL-1RA, Dose 4: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IL-1RA, Dose 4: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IL-1RA, Dose 10: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IL-1RA, Dose 10: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IL-1RA, Dose 10: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IL-1RA, ATI Remission Visit
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IP-10, Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IP-10, Dose 1: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IP-10, Dose 1: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IP-10, Dose 4: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IP-10, Dose 4: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IP-10, Dose 4: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IP-10, Dose 10: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IP-10, Dose 10: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IP-10, Dose 10: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.066
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments IP-10, ATI Remission
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ITAC, Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ITAC, Dose 1: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ITAC, Dose 1: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ITAC, Dose 4: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ITAC, Dose 4: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ITAC, Dose 4: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ITAC, Dose 10: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ITAC, Dose 10: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ITAC, Dose 10: Day 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ITAC, ATI Remission
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
7.Secondary Outcome
Title Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood
Hide Description Following ISGs Levels were evaluated: Interferon-stimulated Gene 15 (ISG15), Oligoadenylate synthase-1 (OAS-1), and interferon-induced guanosine triphosphate-binding protein MX1. Fold change was calculated as postbaseline value divided by baseline value.
Time Frame Baseline and Dose 1: Day 2; Dose 4: Days 1,2; Dose 10: Day 1,2; Early Study Drug Discontinuation (7 days post- last ATI visit at Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Vesatolimod Placebo
Hide Arm/Group Description:
Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Overall Number of Participants Analyzed 17 8
Mean (Standard Deviation)
Unit of Measure: fold change
ISG15, Dose 1: Day 2 Number Analyzed 17 participants 8 participants
19.53  (15.548) 1.06  (0.320)
ISG15, Dose 4: Day 1 Number Analyzed 15 participants 8 participants
3.35  (5.212) 1.24  (0.343)
ISG15, Dose 4: Day 2 Number Analyzed 16 participants 8 participants
19.09  (15.113) 8.41  (20.782)
ISG15, Dose 10: Day 1 Number Analyzed 15 participants 8 participants
1.62  (0.742) 1.02  (0.223)
ISG15, Dose 10: Day 2 Number Analyzed 15 participants 8 participants
19.71  (20.209) 1.02  (0.366)
ISG15, Early Study Drug Discontinuation Number Analyzed 1 participants 0 participants
1.14
OAS-1, Dose 1: Day 2 Number Analyzed 17 participants 8 participants
6.83  (4.225) 1.07  (0.285)
OAS-1, Dose 4: Day 1 Number Analyzed 15 participants 8 participants
2.21  (2.087) 1.13  (0.395)
OAS-1, Dose 4: Day 2 Number Analyzed 16 participants 8 participants
7.44  (4.650) 2.62  (4.676)
OAS-1, Dose 10: Day 1 Number Analyzed 15 participants 8 participants
1.47  (0.665) 1.03  (0.218)
OAS-1, Dose 10: Day 2 Number Analyzed 15 participants 8 participants
6.83  (5.189) 1.04  (0.162)
OAS-1, Early Study Drug Discontinuation Number Analyzed 1 participants 0 participants
1.08
MX1, Dose 1: Day 2 Number Analyzed 17 participants 8 participants
9.36  (6.873) 1.06  (0.249)
MX1, Dose 4: Day 1 Number Analyzed 15 participants 8 participants
2.98  (4.650) 1.17  (0.312)
MX1, Dose 4: Day 2 Number Analyzed 16 participants 8 participants
9.91  (8.061) 3.49  (6.957)
MX1, Dose 10: Day 1 Number Analyzed 15 participants 8 participants
1.59  (0.844) 1.03  (0.226)
MX1, Dose 10: Day 2 Number Analyzed 15 participants 8 participants
10.29  (8.862) 0.98  (0.232)
MX1, Early Study Drug Discontinuation Number Analyzed 1 participants 0 participants
1.06
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ISG15, Dose 1: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ISG15, Dose 4: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ISG15, Dose 4: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments ISG15, Dose 10: Day 1
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments ISG15, Dose 10: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments OAS-1, Dose 1: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments OAS-1, Dose 4: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments OAS-1, Dose 4: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments OAS-1, Dose 10: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments OAS-1, Dose 10: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments MX1, Dose 1: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments MX1, Dose 4: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments MX1, Dose 4: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments MX1, Dose 10: Day 1
Statistical Test of Hypothesis P-Value 0.100
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments MX1, Dose 10: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
8.Secondary Outcome
Title Change From Baseline in Immune Cell Activation
Hide Description Activation of Immune cells (T cells: CD4/CD38/HLADR, CD8/CD38/HLADR and NK cells: CD69+CD56+CD16+, CD69+CD56dimCD16neg, CD69+CD56brCD16dim) was measured by cytometry.
Time Frame Baseline and Dose 4: Days 1,2,4; Dose 6: Days 1,4; Dose 10: Days 1,2,4,14; ATI Remission Visit (12 weeks post ATI Visit: evaluated at maximum of 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Vesatolimod Placebo
Hide Arm/Group Description:
Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Overall Number of Participants Analyzed 9 6
Mean (Standard Deviation)
Unit of Measure: percentage of cell activation
CD4/CD38/HLADR, Baseline Number Analyzed 8 participants 6 participants
2.7  (0.94) 2.3  (1.04)
CD4/CD38/HLADR,Change at Dose 4: Day 1 Number Analyzed 5 participants 6 participants
0.4  (0.58) -0.3  (0.38)
CD4/CD38/HLADR,Change at Dose 4: Day 2 Number Analyzed 5 participants 6 participants
0.9  (0.88) 0.4  (1.02)
CD4/CD38/HLADR,Change at Dose 4: Day 4 Number Analyzed 4 participants 5 participants
0.7  (0.53) -0.3  (0.74)
CD4/CD38/HLADR,Change at Dose 6: Day 1 Number Analyzed 4 participants 6 participants
0.5  (0.41) -0.2  (0.90)
CD4/CD38/HLADR,Change at Dose 6: Day 4 Number Analyzed 4 participants 6 participants
0.9  (0.41) -0.1  (1.20)
CD4/CD38/HLADR,Change at Dose 10: Day 1 Number Analyzed 3 participants 5 participants
1.0  (0.56) -0.4  (0.45)
CD4/CD38/HLADR,Change at Dose 10: Day 2 Number Analyzed 2 participants 5 participants
2.6  (0.11) -0.3  (0.75)
CD4/CD38/HLADR,Change at Dose 10: Day 4 Number Analyzed 4 participants 6 participants
1.0  (1.60) -0.2  (1.45)
CD4/CD38/HLADR,Change at Dose 10: Day 14 Number Analyzed 7 participants 6 participants
0.5  (0.36) 0.1  (1.16)
CD4/CD38/HLADR,Change at ATI Remission Number Analyzed 0 participants 2 participants
1.3  (1.63)
CD8/CD38/HLADR, Baseline Number Analyzed 8 participants 6 participants
5.4  (2.43) 5.2  (2.86)
CD8/CD38/HLADR,Change at Dose 4: Day 1 Number Analyzed 5 participants 6 participants
0.6  (1.41) -0.8  (1.23)
CD8/CD38/HLADR,Change at Dose 4: Day 2 Number Analyzed 5 participants 6 participants
1.6  (1.19) 0.2  (2.06)
CD8/CD38/HLADR,Change at Dose 4: Day 4 Number Analyzed 4 participants 5 participants
0.8  (0.56) -0.9  (1.83)
CD8/CD38/HLADR,Change at Dose 6: Day 1 Number Analyzed 4 participants 6 participants
-0.6  (0.70) -1.1  (1.56)
CD8/CD38/HLADR,Change at Dose 6: Day 4 Number Analyzed 4 participants 6 participants
1.5  (1.53) -0.7  (2.14)
CD8/CD38/HLADR,Change at Dose 10: Day 1 Number Analyzed 3 participants 5 participants
1.5  (2.82) -1.3  (1.77)
CD8/CD38/HLADR,Change at Dose 10: Day 2 Number Analyzed 2 participants 5 participants
7.0  (4.83) -1.2  (2.09)
CD8/CD38/HLADR,Change at Dose 10: Day 4 Number Analyzed 4 participants 6 participants
3.0  (3.25) -1.3  (2.31)
CD8/CD38/HLADR,Change at Dose 10: Day 14 Number Analyzed 7 participants 6 participants
1.6  (3.03) 0.0  (2.81)
CD8/CD38/HLADR,Change at ATI Remission Visit Number Analyzed 0 participants 2 participants
6.0  (6.41)
CD69+CD56+CD16+, Baseline Number Analyzed 9 participants 6 participants
7.5  (7.04) 6.7  (6.31)
CD69+CD56+CD16+,Change at Dose 4: Day 1 Number Analyzed 6 participants 6 participants
-2.2  (5.43) -0.4  (3.24)
CD69+CD56+CD16+,Change at Dose 4: Day 2 Number Analyzed 6 participants 6 participants
4.5  (7.45) 0.5  (2.81)
CD69+CD56+CD16+,Change at Dose 4: Day 4 Number Analyzed 5 participants 5 participants
1.0  (3.04) 0.0  (5.12)
CD69+CD56+CD16+,Change at Dose 6: Day 1 Number Analyzed 4 participants 6 participants
0.2  (2.36) 0.4  (4.32)
CD69+CD56+CD16+,Change at Dose 6: Day 4 Number Analyzed 4 participants 6 participants
0.9  (0.95) -1.5  (4.78)
CD69+CD56+CD16+,Change at Dose 10: Day 1 Number Analyzed 3 participants 5 participants
0.5  (0.61) -1.2  (4.67)
CD69+CD56+CD16+,Change at Dose 10: Day 2 Number Analyzed 2 participants 5 participants
11.1  (2.72) -2.2  (5.81)
CD69+CD56+CD16+,Change at Dose 10: Day 4 Number Analyzed 4 participants 6 participants
1.7  (1.99) -1.4  (5.10)
CD69+CD56+CD16+,Change at Dose 10: Day 14 Number Analyzed 7 participants 6 participants
0.8  (6.77) -0.4  (3.92)
CD69+CD56+CD16+,Change at ATI Remission Visit Number Analyzed 0 participants 2 participants
-1.7  (1.34)
CD69+CD56dimCD16neg, Baseline Number Analyzed 9 participants 6 participants
12.2  (6.41) 11.3  (10.37)
CD69+CD56dimCD16neg,Change at Dose 4: Day 1 Number Analyzed 6 participants 6 participants
-1.8  (5.13) -0.7  (2.72)
CD69+CD56dimCD16neg,Change at Dose 4: Day 2 Number Analyzed 6 participants 6 participants
6.7  (4.95) -0.8  (4.10)
CD69+CD56dimCD16neg,Change at Dose 4: Day 4 Number Analyzed 5 participants 5 participants
1.9  (6.02) -1.1  (6.50)
CD69+CD56dimCD16neg,Change at Dose 6: Day 1 Number Analyzed 4 participants 6 participants
-0.7  (5.36) -3.0  (7.89)
CD69+CD56dimCD16neg,Change at Dose 6: Day 4 Number Analyzed 4 participants 6 participants
2.6  (3.81) -3.0  (7.00)
CD69+CD56dimCD16neg,Change at Dose 10: Day 1 Number Analyzed 3 participants 5 participants
-0.7  (5.15) -3.7  (7.02)
CD69+CD56dimCD16neg,Change at Dose 10: Day 2 Number Analyzed 2 participants 5 participants
23.9  (8.15) -4.2  (7.94)
CD69+CD56dimCD16neg,Change at Dose 10: Day 4 Number Analyzed 4 participants 6 participants
2.0  (2.55) -2.0  (6.70)
CD69+CD56dimCD16neg,Change at Dose 10: Day 14 Number Analyzed 7 participants 6 participants
1.6  (4.89) -2.5  (8.49)
CD69+CD56dimCD16neg,Change at Dose 10: ATI Remission Number Analyzed 0 participants 2 participants
-7.3  (13.15)
CD69+CD56brCD16dim, Baseline Number Analyzed 9 participants 6 participants
5.0  (2.68) 2.6  (1.02)
CD69+CD56brCD16dim,Change at Dose 4: Day 1 Number Analyzed 6 participants 6 participants
-1.5  (1.46) -0.3  (1.89)
CD69+CD56brCD16dim,Change at Dose 4: Day 2 Number Analyzed 6 participants 6 participants
1.0  (2.98) 0.6  (2.49)
CD69+CD56brCD16dim,Change at Dose 4: Day 4 Number Analyzed 5 participants 5 participants
0.9  (1.63) 2.9  (2.13)
CD69+CD56brCD16dim,Change at Dose 6: Day 1 Number Analyzed 4 participants 6 participants
1.9  (2.09) 1.5  (2.90)
CD69+CD56brCD16dim,Change at Dose 6: Day 4 Number Analyzed 4 participants 6 participants
6.2  (6.68) 0.2  (1.72)
CD69+CD56brCD16dim,Change at Dose 10: Day 1 Number Analyzed 3 participants 5 participants
5.0  (7.00) 1.3  (1.72)
CD69+CD56brCD16dim,Change at Dose 10: Day 2 Number Analyzed 2 participants 5 participants
17.2  (16.49) 2.2  (5.08)
CD69+CD56brCD16dim,Change at Dose 10: Day 4 Number Analyzed 4 participants 6 participants
0.0  (1.46) 3.3  (3.70)
CD69+CD56brCD16dim,Change at Dose 10: Day 14 Number Analyzed 7 participants 6 participants
2.7  (3.14) 0.9  (2.93)
CD69+CD56brCD16dim,Change at ATI Remission Number Analyzed 0 participants 2 participants
0.2  (0.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD4/CD38/HLADR, Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7469
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD4/CD38/HLADR, Dose 4: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1207
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD4/CD38/HLADR, Dose 4: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4113
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD4/CD38/HLADR, Dose 4: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1113
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD4/CD38/HLADR, Dose 6: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2410
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD4/CD38/HLADR, Dose 6: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1098
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD4/CD38/HLADR, Dose 10: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0369
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD4/CD38/HLADR, Dose 10: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0814
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD4/CD38/HLADR, Dose 10: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1658
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD4/CD38/HLADR, Dose 10: Day 14
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9431
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD8/CD38/HLADR, Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6514
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD8/CD38/HLADR, Dose 4: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0821
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD8/CD38/HLADR, Dose 4: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2353
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD8/CD38/HLADR, Dose 4: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1779
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD8/CD38/HLADR, Dose 6: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7491
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD8/CD38/HLADR, Dose 6: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0700
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD8/CD38/HLADR, Dose 10: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3711
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD8/CD38/HLADR, Dose 10: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0814
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD8/CD38/HLADR, Dose 10: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0700
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD8/CD38/HLADR, Dose 10: Day 14
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8303
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56+CD16+, Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9530
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56+CD16+, Dose 4: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1735
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56+CD16+, Dose 4: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2971
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56+CD16+, Dose 4: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56+CD16+, Dose 6: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56+CD16+, Dose 6: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3374
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56+CD16+, Dose 10: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7656
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56+CD16+, Dose 10: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0814
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56+CD16+, Dose 10: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3374
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56+CD16+, Dose 10: Day 14
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4320
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56dimCD16neg, Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8597
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56dimCD16neg, Dose 4: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56dimCD16neg, Dose 4: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0306
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56dimCD16neg, Dose 4: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8345
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56dimCD16neg, Dose 6: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9151
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56dimCD16neg, Dose 6: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1098
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56dimCD16neg, Dose 10: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56dimCD16neg, Dose 10: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0814
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56dimCD16neg, Dose 10: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4555
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56dimCD16neg, Dose 10: Day 14
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6171
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56brCD16dim, Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0677
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56brCD16dim, Dose 4: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4712
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56brCD16dim, Dose 4: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6889
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56brCD16dim, Dose 4: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1437
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56brCD16dim, Dose 6: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7491
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56brCD16dim, Dose 6: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0700
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56brCD16dim, Dose 10: Day 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7656
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56brCD16dim, Dose 10: Day 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1752
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments CD69+CD56brCD16dim, Dose 10: Day 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0700
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Vesatolimod, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments CD69+CD56brCD16dim, Dose 10: Day 14
Statistical Test of Hypothesis P-Value 0.2246
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments P-values are based on two-sided Wilcoxon rank sum tests.
9.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: Cmax of Vesatolimod
Hide Description Cmax is defined as the maximum concentration of drug.
Time Frame Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit.
Hide Outcome Measure Data
Hide Analysis Population Description
The vesatolimod PK Analysis Set included all participants who were randomized into the study, received at least 1 dose of active vesatolimod, and had at least 1 non-missing post baseline concentration value for vesatolimod. Per planned analysis this outcome measure was analyzed by actual treatment received (i.e. 'Vesatolimod').
Arm/Group Title Vesatolimod
Hide Arm/Group Description:
Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: pg/mL
7149.6  (7662.17)
10.Secondary Outcome
Title PK Parameter: AUClast of Vesatolimod
Hide Description AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time Frame Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the vesatolimod PK Analysis Set were analyzed. Per planned analysis this outcome measure was analyzed by actual treatment received (i.e. 'Vesatolimod').
Arm/Group Title Vesatolimod
Hide Arm/Group Description:
Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: hour*pg/ml
49323.5  (48542.34)
11.Secondary Outcome
Title PK Parameter: AUCinf of Vesatolimod
Hide Description AUCinf was defined as the concentration of drug extrapolated to infinite time.
Time Frame Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the vesatolimod PK Analysis Set with available data were analyzed. Per planned analysis this outcome measure was analyzed by actual treatment received (i.e. 'Vesatolimod').
Arm/Group Title Vesatolimod
Hide Arm/Group Description:
Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: hour*pg/mL
60040.3  (59280.72)
12.Secondary Outcome
Title PK Parameter: %AUCexp of Vesatolimod
Hide Description %AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf.
Time Frame Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the vesatolimod PK Analysis Set with available data were analyzed. Per planned analysis this outcome measure was analyzed by actual treatment received (i.e. 'Vesatolimod').
Arm/Group Title Vesatolimod
Hide Arm/Group Description:
Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Percentage of AUC
22.4  (7.90)
13.Secondary Outcome
Title PK Parameter: Tmax of Vesatolimod
Hide Description Tmax is defined as the time (observed time point) of Cmax.
Time Frame Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the vesatolimod PK Analysis Set with available data were analyzed. Per planned analysis this outcome measure was analyzed by actual treatment received (i.e. 'Vesatolimod').
Arm/Group Title Vesatolimod
Hide Arm/Group Description:
Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: hour
2.00
(0.50 to 6.00)
Time Frame From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days)
Adverse Event Reporting Description The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
 
Arm/Group Title Vesatolimod Placebo
Hide Arm/Group Description Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
All-Cause Mortality
Vesatolimod Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
Vesatolimod Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/17 (5.88%)   0/8 (0.00%) 
Gastrointestinal disorders     
Chronic gastritis  1  1/17 (5.88%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA (22.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vesatolimod Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   16/17 (94.12%)   6/8 (75.00%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  3/17 (17.65%)  0/8 (0.00%) 
Cardiac disorders     
Bradycardia  1  1/17 (5.88%)  0/8 (0.00%) 
Eye disorders     
Blepharospasm  1  1/17 (5.88%)  0/8 (0.00%) 
Gastrointestinal disorders     
Abdominal pain lower  1  1/17 (5.88%)  0/8 (0.00%) 
Abdominal pain upper  1  1/17 (5.88%)  0/8 (0.00%) 
Angular cheilitis  1  1/17 (5.88%)  0/8 (0.00%) 
Chapped lips  1  1/17 (5.88%)  0/8 (0.00%) 
Diarrhoea  1  1/17 (5.88%)  0/8 (0.00%) 
Faeces soft  1  1/17 (5.88%)  0/8 (0.00%) 
Nausea  1  5/17 (29.41%)  1/8 (12.50%) 
Swollen tongue  1  1/17 (5.88%)  0/8 (0.00%) 
Umbilical hernia  1  1/17 (5.88%)  1/8 (12.50%) 
Vomiting  1  1/17 (5.88%)  0/8 (0.00%) 
General disorders     
Chills  1  4/17 (23.53%)  0/8 (0.00%) 
Fatigue  1  3/17 (17.65%)  0/8 (0.00%) 
Malaise  1  2/17 (11.76%)  0/8 (0.00%) 
Pyrexia  1  3/17 (17.65%)  0/8 (0.00%) 
Vessel puncture site bruise  1  2/17 (11.76%)  0/8 (0.00%) 
Infections and infestations     
Acute sinusitis  1  2/17 (11.76%)  0/8 (0.00%) 
Gastroenteritis viral  1  1/17 (5.88%)  1/8 (12.50%) 
Laryngitis  1  1/17 (5.88%)  0/8 (0.00%) 
Nasopharyngitis  1  2/17 (11.76%)  0/8 (0.00%) 
Sinusitis  1  3/17 (17.65%)  2/8 (25.00%) 
Tinea cruris  1  1/17 (5.88%)  0/8 (0.00%) 
Urinary tract infection  1  1/17 (5.88%)  0/8 (0.00%) 
Viral infection  1  1/17 (5.88%)  0/8 (0.00%) 
Injury, poisoning and procedural complications     
Foot fracture  1  0/17 (0.00%)  1/8 (12.50%) 
Procedural pain  1  1/17 (5.88%)  0/8 (0.00%) 
Rib fracture  1  1/17 (5.88%)  0/8 (0.00%) 
Tooth fracture  1  1/17 (5.88%)  0/8 (0.00%) 
Investigations     
Weight decreased  1  1/17 (5.88%)  0/8 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/17 (5.88%)  0/8 (0.00%) 
Gout  1  1/17 (5.88%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/17 (17.65%)  0/8 (0.00%) 
Back pain  1  1/17 (5.88%)  1/8 (12.50%) 
Bursitis  1  0/17 (0.00%)  1/8 (12.50%) 
Muscle spasms  1  1/17 (5.88%)  0/8 (0.00%) 
Myalgia  1  1/17 (5.88%)  0/8 (0.00%) 
Pain in extremity  1  0/17 (0.00%)  1/8 (12.50%) 
Pain in jaw  1  0/17 (0.00%)  1/8 (12.50%) 
Tendonitis  1  1/17 (5.88%)  0/8 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Seborrhoeic keratosis  1  1/17 (5.88%)  0/8 (0.00%) 
Nervous system disorders     
Dizziness  1  1/17 (5.88%)  0/8 (0.00%) 
Headache  1  5/17 (29.41%)  3/8 (37.50%) 
Neuropathy peripheral  1  1/17 (5.88%)  0/8 (0.00%) 
Sciatica  1  1/17 (5.88%)  0/8 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Morning sickness  1  1/17 (5.88%)  0/8 (0.00%) 
Reproductive system and breast disorders     
Haematospermia  1  0/17 (0.00%)  1/8 (12.50%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/17 (5.88%)  0/8 (0.00%)