Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated Human Immunodeficiency Virus (HIV-1) Infected Controllers (NCT NCT03060447)

NCT ID: NCT03060447

Last Updated: 2021-04-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 25 participants
• Primary outcome timeframe: From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days)
• Results posted on: 2021-04-21

Participant Flow

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.

31 participants were screened.

Participant milestones

Measure	Vesatolimod 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.	Placebo 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 Study STARTED	17	8
Overall Study COMPLETED	15	8
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Vesatolimod 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.	Placebo 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 Study Withdrawal by Subject	2	0

Baseline Characteristics

Study to Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated Human Immunodeficiency Virus (HIV-1) Infected Controllers

Baseline characteristics by cohort

Measure	Vesatolimod n=17 Participants 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.	Placebo n=8 Participants 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 n=25 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 11.4 • n=5 Participants	42 years STANDARD_DEVIATION 9.4 • n=7 Participants	46 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
HIV-1 RNA	1.30 log10 copies/mL STANDARD_DEVIATION 0.108 • n=5 Participants	1.28 log10 copies/mL STANDARD_DEVIATION 0.000 • n=7 Participants	1.30 log10 copies/mL STANDARD_DEVIATION 0.089 • n=5 Participants
HIV-1 RNA Category < 50 copies/mL	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
HIV-1 RNA Category ≥ 50 copies/mL	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Pre-ART Plasma Viral Set-point	3.15 log10 copies/mL STANDARD_DEVIATION 0.275 • n=5 Participants	3.08 log10 copies/mL STANDARD_DEVIATION 0.469 • n=7 Participants	3.13 log10 copies/mL STANDARD_DEVIATION 0.340 • n=5 Participants

PRIMARY outcome

Timeframe: From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days)

Population: 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.

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.

Outcome measures

Measure	Vesatolimod 4 mg n=2 Participants 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.	Vesatolimod 4/6 mg n=4 Participants 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.	Vesatolimod 6 mg n=5 Participants 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.	Vesatolimod 6/8 mg n=3 Participants 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.	Vesatolimod 8 mg n=3 Participants 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.	Placebo n=8 Participants 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.
Percentage of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events (TEAEs) TESAEs	0 percentage of participants	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events (TEAEs) TEAEs	100.00 percentage of participants	75.00 percentage of participants	100.00 percentage of participants	100.00 percentage of participants	100.00 percentage of participants	75.00 percentage of participants

SECONDARY outcome

Timeframe: 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

Population: 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.

Plasma log 10 HIV-1 RNA was measured using Taqman version 2.0 assay with limit of quantification of 20 copies/mL.

Outcome measures

Measure	Vesatolimod 4 mg n=17 Participants 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.	Vesatolimod 4/6 mg n=8 Participants 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.	Vesatolimod 6 mg 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.	Vesatolimod 6/8 mg 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.	Vesatolimod 8 mg 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.	Placebo 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.
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 7: Day 1	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 7: Day 8	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 1: Day 2	-0.01 Log10 copies/mL Standard Deviation 0.027	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 1: Day 8	0.05 Log10 copies/mL Standard Deviation 0.212	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 2: Day 1	0.09 Log10 copies/mL Standard Deviation 0.372	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 2: Day 8	-0.03 Log10 copies/mL Standard Deviation 0.111	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 3: Day 1	-0.03 Log10 copies/mL Standard Deviation 0.111	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 3: Day 8	-0.03 Log10 copies/mL Standard Deviation 0.111	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 4: Day 1	-0.03 Log10 copies/mL Standard Deviation 0.111	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 4: Day 2	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 4: Day 4	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 4: Day 8	-0.03 Log10 copies/mL Standard Deviation 0.111	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 5: Day 1	-0.03 Log10 copies/mL Standard Deviation 0.111	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 5: Day 8	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 6: Day 1	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 6: Day 4	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 6: Day 8	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 8: Day 1	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 8: Day 8	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 9: Day 1	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 9: Day 8	0.00 Log10 copies/mL Standard Deviation 0.000	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 10: Day 1	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 10: Day 2	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 10: Day 4	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 10: Day 8	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—
Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 Change at Dose 10: Day 14	-0.03 Log10 copies/mL Standard Deviation 0.115	0.00 Log10 copies/mL Standard Deviation 0.000	—	—	—	—

SECONDARY outcome

Timeframe: 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

Population: Participants in the Full Analysis Set with available data were analyzed.

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.

Outcome measures

Measure	Vesatolimod 4 mg n=15 Participants 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.	Vesatolimod 4/6 mg n=8 Participants 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.	Vesatolimod 6 mg 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.	Vesatolimod 6/8 mg 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.	Vesatolimod 8 mg 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.	Placebo 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.
Time to Virologic Rebound ≥ 50 Copies/mL	4.3 weeks Interval 3.1 to 6.1	4.0 weeks Interval 3.0 to 4.2	—	—	—	—
Time to Virologic Rebound ≥ 200 Copies/mL	5.1 weeks Interval 4.1 to 6.3	4.1 weeks Interval 3.8 to 4.6	—	—	—	—

SECONDARY outcome

Timeframe: From Week 1 up to Week 24

Population: Participants in the Full Analysis Set with available data were analyzed.

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.

Outcome measures

Measure	Vesatolimod 4 mg n=15 Participants 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.	Vesatolimod 4/6 mg n=8 Participants 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.	Vesatolimod 6 mg 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.	Vesatolimod 6/8 mg 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.	Vesatolimod 8 mg 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.	Placebo 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.
Peak HIV-1 Viral Load During Period 2	4.21 Log10 copies/mL Interval 3.39 to 4.88	3.97 Log10 copies/mL Interval 3.29 to 4.32	—	—	—	—

SECONDARY outcome

Timeframe: Pre-ART (Initial Screening Visit) and 24 weeks plus 6 months following virologic re-suppression on ART (maximum 33 months and 5 days)

Population: Participants in the Full Analysis Set with available data were analyzed.

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.

Outcome measures

Measure	Vesatolimod 4 mg n=15 Participants 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.	Vesatolimod 4/6 mg n=7 Participants 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.	Vesatolimod 6 mg 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.	Vesatolimod 6/8 mg 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.	Vesatolimod 8 mg 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.	Placebo 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.
Change in Plasma Viral Load Set-Point Following ATI	-0.37 Log10 copies/mL Interval -0.59 to -0.05	-0.28 Log10 copies/mL Interval -0.56 to 0.17	—	—	—	—

SECONDARY outcome

Timeframe: 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)

Population: Participants in the Full Analysis Set with available data were analyzed.

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).

Outcome measures

Measure	Vesatolimod 4 mg n=17 Participants 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.	Vesatolimod 4/6 mg n=8 Participants 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.	Vesatolimod 6 mg 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.	Vesatolimod 6/8 mg 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.	Vesatolimod 8 mg 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.	Placebo 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.
Change From Baseline in Levels of Serum Cytokines IP-10,Change at Dose 10: Day 2	554.6 pg/mL Standard Deviation 893.70	-17.5 pg/mL Standard Deviation 50.94	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IP-10, Change at Dose 10: Day 8	18.1 pg/mL Standard Deviation 82.14	-51.1 pg/mL Standard Deviation 57.23	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IP-10,Change at ATI Remission	47.5 pg/mL Standard Deviation 48.42	26.2 pg/mL Standard Deviation 92.41	—	—	—	—
Change From Baseline in Levels of Serum Cytokines ITAC,Change at Dose 10: Day 2	69.1 pg/mL Standard Deviation 181.55	-1.0 pg/mL Standard Deviation 27.68	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IFN-a, Baseline	0.02 pg/mL Standard Deviation 0.036	0.05 pg/mL Standard Deviation 0.075	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IFN-a,Change at Dose 1: Day 2	0.41 pg/mL Standard Deviation 0.834	-0.01 pg/mL Standard Deviation 0.073	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IFN-a,Change at Dose 1: Day 8	0.14 pg/mL Standard Deviation 0.447	0.04 pg/mL Standard Deviation 0.129	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IFN-a,Change at Dose 4: Day 1	-0.01 pg/mL Standard Deviation 0.030	0.10 pg/mL Standard Deviation 0.358	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IFN-a,Change at Dose 4: Day 2	0.75 pg/mL Standard Deviation 2.361	-0.01 pg/mL Standard Deviation 0.065	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IFN-a,Change at Dose 4: Day 8	0.01 pg/mL Standard Deviation 0.064	-0.03 pg/mL Standard Deviation 0.077	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IFN-a,Change at Dose 10: Day 1	-0.01 pg/mL Standard Deviation 0.031	-0.03 pg/mL Standard Deviation 0.056	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IFN-a,Change at Dose 10: Day 2	0.51 pg/mL Standard Deviation 1.028	-0.02 pg/mL Standard Deviation 0.055	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IFN-a,Change at Dose 10: Day 8	0.01 pg/mL Standard Deviation 0.072	-0.04 pg/mL Standard Deviation 0.065	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IFN-a,Change at ATI Remission Visit	-0.03 pg/mL Standard Deviation 0.059	0.17 pg/mL Standard Deviation 0.301	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IFN-a,Change at Early study drug discontinuation	0.00 pg/mL	—	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IL-1RA, Baseline	2346.1 pg/mL Standard Deviation 3743.44	882.9 pg/mL Standard Deviation 306.75	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IL-1RA,Change at Dose 1: Day 2	2797.6 pg/mL Standard Deviation 2908.21	94.8 pg/mL Standard Deviation 190.53	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IL-1RA,Change at Dose 1: Day 8	-326.9 pg/mL Standard Deviation 914.43	1004.9 pg/mL Standard Deviation 2432.36	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IL-1RA,Change at Dose 4: Day 1	390.4 pg/mL Standard Deviation 856.29	42.2 pg/mL Standard Deviation 227.90	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IL-1RA,Change at Dose 4: Day 2	5140.4 pg/mL Standard Deviation 8692.35	186.4 pg/mL Standard Deviation 449.94	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IL-1RA,Change at Dose 4: Day 8	-63.9 pg/mL Standard Deviation 1749.75	-143.5 pg/mL Standard Deviation 226.83	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IL-1RA,Change at Dose 10: Day 1	-160.9 pg/mL Standard Deviation 1229.91	563.9 pg/mL Standard Deviation 1201.78	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IL-1RA,Change at Dose 10: Day 2	3790.2 pg/mL Standard Deviation 6401.27	14.1 pg/mL Standard Deviation 467.90	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IL-1RA,Change at Dose 10: Day 8	-77.6 pg/mL Standard Deviation 521.52	-13.9 pg/mL Standard Deviation 308.80	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IL-1RA,Change at ATI Remission Visit	-161.7 pg/mL Standard Deviation 1030.42	491.1 pg/mL Standard Deviation 306.12	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IL-1RA,Change at Early study drug discontinuation	222.4 pg/mL	—	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IP-10, Baseline	161.0 pg/mL Standard Deviation 82.04	178.5 pg/mL Standard Deviation 103.50	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IP-10, Change at Dose 1: Day 2	554.1 pg/mL Standard Deviation 693.55	-23.9 pg/mL Standard Deviation 52.24	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IP-10,Change at Dose 1: Day 8	38.8 pg/mL Standard Deviation 126.82	34.5 pg/mL Standard Deviation 182.93	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IP-10,Change at Dose 4: Day 1	27.8 pg/mL Standard Deviation 71.62	-25.3 pg/mL Standard Deviation 46.15	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IP-10,Change at Dose 4: Day 2	337.9 pg/mL Standard Deviation 487.83	-13.8 pg/mL Standard Deviation 78.10	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IP-10,Change at Dose 4: Day 8	23.4 pg/mL Standard Deviation 58.50	-59.0 pg/mL Standard Deviation 58.04	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IP-10,Change at Dose 10: Day 1	19.1 pg/mL Standard Deviation 44.13	-22.8 pg/mL Standard Deviation 54.29	—	—	—	—
Change From Baseline in Levels of Serum Cytokines IP-10,Change at Early Study Drug Discontinuation	0.7 pg/mL	—	—	—	—	—
Change From Baseline in Levels of Serum Cytokines ITAC, Baseline	71.8 pg/mL Standard Deviation 108.10	206.3 pg/mL Standard Deviation 329.55	—	—	—	—
Change From Baseline in Levels of Serum Cytokines ITAC, Change at Dose 1: Day 2	50.4 pg/mL Standard Deviation 80.46	-13.9 pg/mL Standard Deviation 42.68	—	—	—	—
Change From Baseline in Levels of Serum Cytokines ITAC,Change at Dose 1: Day 8	11.5 pg/mL Standard Deviation 34.78	-10.4 pg/mL Standard Deviation 44.02	—	—	—	—
Change From Baseline in Levels of Serum Cytokines ITAC, Change at Dose 4: Day 1	8.0 pg/mL Standard Deviation 25.97	-25.4 pg/mL Standard Deviation 65.76	—	—	—	—
Change From Baseline in Levels of Serum Cytokines ITAC,Change at Dose 4: Day 2	48.0 pg/mL Standard Deviation 78.14	-8.9 pg/mL Standard Deviation 33.81	—	—	—	—
Change From Baseline in Levels of Serum Cytokines ITAC, Change at Dose 4: Day 8	2.0 pg/mL Standard Deviation 24.20	5.0 pg/mL Standard Deviation 27.98	—	—	—	—
Change From Baseline in Levels of Serum Cytokines ITAC,Change at Dose 10: Day 1	-1.6 pg/mL Standard Deviation 19.11	-8.4 pg/mL Standard Deviation 33.91	—	—	—	—
Change From Baseline in Levels of Serum Cytokines ITAC,Change at Dose 10: Day 8	2.2 pg/mL Standard Deviation 12.19	-7.4 pg/mL Standard Deviation 22.50	—	—	—	—
Change From Baseline in Levels of Serum Cytokines ITAC,Change at ATI Remission	19.1 pg/mL Standard Deviation 20.44	39.6 pg/mL Standard Deviation 88.54	—	—	—	—
Change From Baseline in Levels of Serum Cytokines ITAC,Change at Early Study Drug Discontinuation	31.2 pg/mL	—	—	—	—	—

SECONDARY outcome

Timeframe: 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)

Population: Participants in the Full Analysis Set with available data were analyzed.

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.

Outcome measures

Measure	Vesatolimod 4 mg n=17 Participants 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.	Vesatolimod 4/6 mg n=8 Participants 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.	Vesatolimod 6 mg 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.	Vesatolimod 6/8 mg 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.	Vesatolimod 8 mg 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.	Placebo 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.
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood ISG15, Dose 1: Day 2	19.53 fold change Standard Deviation 15.548	1.06 fold change Standard Deviation 0.320	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood ISG15, Dose 4: Day 1	3.35 fold change Standard Deviation 5.212	1.24 fold change Standard Deviation 0.343	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood ISG15, Dose 4: Day 2	19.09 fold change Standard Deviation 15.113	8.41 fold change Standard Deviation 20.782	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood MX1, Early Study Drug Discontinuation	1.06 fold change	—	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood ISG15, Dose 10: Day 1	1.62 fold change Standard Deviation 0.742	1.02 fold change Standard Deviation 0.223	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood ISG15, Dose 10: Day 2	19.71 fold change Standard Deviation 20.209	1.02 fold change Standard Deviation 0.366	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood ISG15, Early Study Drug Discontinuation	1.14 fold change	—	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood OAS-1, Dose 1: Day 2	6.83 fold change Standard Deviation 4.225	1.07 fold change Standard Deviation 0.285	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood OAS-1, Dose 4: Day 1	2.21 fold change Standard Deviation 2.087	1.13 fold change Standard Deviation 0.395	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood OAS-1, Dose 4: Day 2	7.44 fold change Standard Deviation 4.650	2.62 fold change Standard Deviation 4.676	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood OAS-1, Dose 10: Day 1	1.47 fold change Standard Deviation 0.665	1.03 fold change Standard Deviation 0.218	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood OAS-1, Dose 10: Day 2	6.83 fold change Standard Deviation 5.189	1.04 fold change Standard Deviation 0.162	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood OAS-1, Early Study Drug Discontinuation	1.08 fold change	—	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood MX1, Dose 1: Day 2	9.36 fold change Standard Deviation 6.873	1.06 fold change Standard Deviation 0.249	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood MX1, Dose 4: Day 1	2.98 fold change Standard Deviation 4.650	1.17 fold change Standard Deviation 0.312	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood MX1, Dose 4: Day 2	9.91 fold change Standard Deviation 8.061	3.49 fold change Standard Deviation 6.957	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood MX1, Dose 10: Day 1	1.59 fold change Standard Deviation 0.844	1.03 fold change Standard Deviation 0.226	—	—	—	—
Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood MX1, Dose 10: Day 2	10.29 fold change Standard Deviation 8.862	0.98 fold change Standard Deviation 0.232	—	—	—	—

SECONDARY outcome

Timeframe: 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)

Population: Participants in the Full Analysis Set with available data were analyzed.

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.

Outcome measures

Measure	Vesatolimod 4 mg n=9 Participants 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.	Vesatolimod 4/6 mg n=6 Participants 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.	Vesatolimod 6 mg 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.	Vesatolimod 6/8 mg 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.	Vesatolimod 8 mg 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.	Placebo 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.
Change From Baseline in Immune Cell Activation CD4/CD38/HLADR, Baseline	2.7 percentage of cell activation Standard Deviation 0.94	2.3 percentage of cell activation Standard Deviation 1.04	—	—	—	—
Change From Baseline in Immune Cell Activation CD4/CD38/HLADR,Change at Dose 4: Day 1	0.4 percentage of cell activation Standard Deviation 0.58	-0.3 percentage of cell activation Standard Deviation 0.38	—	—	—	—
Change From Baseline in Immune Cell Activation CD4/CD38/HLADR,Change at Dose 4: Day 2	0.9 percentage of cell activation Standard Deviation 0.88	0.4 percentage of cell activation Standard Deviation 1.02	—	—	—	—
Change From Baseline in Immune Cell Activation CD4/CD38/HLADR,Change at Dose 4: Day 4	0.7 percentage of cell activation Standard Deviation 0.53	-0.3 percentage of cell activation Standard Deviation 0.74	—	—	—	—
Change From Baseline in Immune Cell Activation CD4/CD38/HLADR,Change at Dose 6: Day 1	0.5 percentage of cell activation Standard Deviation 0.41	-0.2 percentage of cell activation Standard Deviation 0.90	—	—	—	—
Change From Baseline in Immune Cell Activation CD4/CD38/HLADR,Change at Dose 6: Day 4	0.9 percentage of cell activation Standard Deviation 0.41	-0.1 percentage of cell activation Standard Deviation 1.20	—	—	—	—
Change From Baseline in Immune Cell Activation CD4/CD38/HLADR,Change at Dose 10: Day 1	1.0 percentage of cell activation Standard Deviation 0.56	-0.4 percentage of cell activation Standard Deviation 0.45	—	—	—	—
Change From Baseline in Immune Cell Activation CD4/CD38/HLADR,Change at Dose 10: Day 2	2.6 percentage of cell activation Standard Deviation 0.11	-0.3 percentage of cell activation Standard Deviation 0.75	—	—	—	—
Change From Baseline in Immune Cell Activation CD4/CD38/HLADR,Change at Dose 10: Day 4	1.0 percentage of cell activation Standard Deviation 1.60	-0.2 percentage of cell activation Standard Deviation 1.45	—	—	—	—
Change From Baseline in Immune Cell Activation CD4/CD38/HLADR,Change at Dose 10: Day 14	0.5 percentage of cell activation Standard Deviation 0.36	0.1 percentage of cell activation Standard Deviation 1.16	—	—	—	—
Change From Baseline in Immune Cell Activation CD4/CD38/HLADR,Change at ATI Remission	—	1.3 percentage of cell activation Standard Deviation 1.63	—	—	—	—
Change From Baseline in Immune Cell Activation CD8/CD38/HLADR, Baseline	5.4 percentage of cell activation Standard Deviation 2.43	5.2 percentage of cell activation Standard Deviation 2.86	—	—	—	—
Change From Baseline in Immune Cell Activation CD8/CD38/HLADR,Change at Dose 4: Day 1	0.6 percentage of cell activation Standard Deviation 1.41	-0.8 percentage of cell activation Standard Deviation 1.23	—	—	—	—
Change From Baseline in Immune Cell Activation CD8/CD38/HLADR,Change at Dose 4: Day 2	1.6 percentage of cell activation Standard Deviation 1.19	0.2 percentage of cell activation Standard Deviation 2.06	—	—	—	—
Change From Baseline in Immune Cell Activation CD8/CD38/HLADR,Change at Dose 4: Day 4	0.8 percentage of cell activation Standard Deviation 0.56	-0.9 percentage of cell activation Standard Deviation 1.83	—	—	—	—
Change From Baseline in Immune Cell Activation CD8/CD38/HLADR,Change at Dose 6: Day 1	-0.6 percentage of cell activation Standard Deviation 0.70	-1.1 percentage of cell activation Standard Deviation 1.56	—	—	—	—
Change From Baseline in Immune Cell Activation CD8/CD38/HLADR,Change at Dose 6: Day 4	1.5 percentage of cell activation Standard Deviation 1.53	-0.7 percentage of cell activation Standard Deviation 2.14	—	—	—	—
Change From Baseline in Immune Cell Activation CD8/CD38/HLADR,Change at Dose 10: Day 1	1.5 percentage of cell activation Standard Deviation 2.82	-1.3 percentage of cell activation Standard Deviation 1.77	—	—	—	—
Change From Baseline in Immune Cell Activation CD8/CD38/HLADR,Change at Dose 10: Day 2	7.0 percentage of cell activation Standard Deviation 4.83	-1.2 percentage of cell activation Standard Deviation 2.09	—	—	—	—
Change From Baseline in Immune Cell Activation CD8/CD38/HLADR,Change at Dose 10: Day 4	3.0 percentage of cell activation Standard Deviation 3.25	-1.3 percentage of cell activation Standard Deviation 2.31	—	—	—	—
Change From Baseline in Immune Cell Activation CD8/CD38/HLADR,Change at Dose 10: Day 14	1.6 percentage of cell activation Standard Deviation 3.03	0.0 percentage of cell activation Standard Deviation 2.81	—	—	—	—
Change From Baseline in Immune Cell Activation CD8/CD38/HLADR,Change at ATI Remission Visit	—	6.0 percentage of cell activation Standard Deviation 6.41	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56+CD16+, Baseline	7.5 percentage of cell activation Standard Deviation 7.04	6.7 percentage of cell activation Standard Deviation 6.31	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56+CD16+,Change at Dose 4: Day 1	-2.2 percentage of cell activation Standard Deviation 5.43	-0.4 percentage of cell activation Standard Deviation 3.24	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56+CD16+,Change at Dose 4: Day 2	4.5 percentage of cell activation Standard Deviation 7.45	0.5 percentage of cell activation Standard Deviation 2.81	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56+CD16+,Change at Dose 4: Day 4	1.0 percentage of cell activation Standard Deviation 3.04	0.0 percentage of cell activation Standard Deviation 5.12	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56+CD16+,Change at Dose 6: Day 1	0.2 percentage of cell activation Standard Deviation 2.36	0.4 percentage of cell activation Standard Deviation 4.32	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56+CD16+,Change at Dose 6: Day 4	0.9 percentage of cell activation Standard Deviation 0.95	-1.5 percentage of cell activation Standard Deviation 4.78	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56+CD16+,Change at Dose 10: Day 1	0.5 percentage of cell activation Standard Deviation 0.61	-1.2 percentage of cell activation Standard Deviation 4.67	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56+CD16+,Change at Dose 10: Day 2	11.1 percentage of cell activation Standard Deviation 2.72	-2.2 percentage of cell activation Standard Deviation 5.81	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56+CD16+,Change at Dose 10: Day 4	1.7 percentage of cell activation Standard Deviation 1.99	-1.4 percentage of cell activation Standard Deviation 5.10	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56+CD16+,Change at Dose 10: Day 14	0.8 percentage of cell activation Standard Deviation 6.77	-0.4 percentage of cell activation Standard Deviation 3.92	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56+CD16+,Change at ATI Remission Visit	—	-1.7 percentage of cell activation Standard Deviation 1.34	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56dimCD16neg, Baseline	12.2 percentage of cell activation Standard Deviation 6.41	11.3 percentage of cell activation Standard Deviation 10.37	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56dimCD16neg,Change at Dose 4: Day 1	-1.8 percentage of cell activation Standard Deviation 5.13	-0.7 percentage of cell activation Standard Deviation 2.72	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56dimCD16neg,Change at Dose 4: Day 2	6.7 percentage of cell activation Standard Deviation 4.95	-0.8 percentage of cell activation Standard Deviation 4.10	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56dimCD16neg,Change at Dose 4: Day 4	1.9 percentage of cell activation Standard Deviation 6.02	-1.1 percentage of cell activation Standard Deviation 6.50	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56dimCD16neg,Change at Dose 6: Day 1	-0.7 percentage of cell activation Standard Deviation 5.36	-3.0 percentage of cell activation Standard Deviation 7.89	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56dimCD16neg,Change at Dose 6: Day 4	2.6 percentage of cell activation Standard Deviation 3.81	-3.0 percentage of cell activation Standard Deviation 7.00	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56dimCD16neg,Change at Dose 10: Day 1	-0.7 percentage of cell activation Standard Deviation 5.15	-3.7 percentage of cell activation Standard Deviation 7.02	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56dimCD16neg,Change at Dose 10: Day 2	23.9 percentage of cell activation Standard Deviation 8.15	-4.2 percentage of cell activation Standard Deviation 7.94	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56dimCD16neg,Change at Dose 10: Day 4	2.0 percentage of cell activation Standard Deviation 2.55	-2.0 percentage of cell activation Standard Deviation 6.70	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56dimCD16neg,Change at Dose 10: Day 14	1.6 percentage of cell activation Standard Deviation 4.89	-2.5 percentage of cell activation Standard Deviation 8.49	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56dimCD16neg,Change at Dose 10: ATI Remission	—	-7.3 percentage of cell activation Standard Deviation 13.15	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56brCD16dim, Baseline	5.0 percentage of cell activation Standard Deviation 2.68	2.6 percentage of cell activation Standard Deviation 1.02	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56brCD16dim,Change at Dose 4: Day 1	-1.5 percentage of cell activation Standard Deviation 1.46	-0.3 percentage of cell activation Standard Deviation 1.89	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56brCD16dim,Change at Dose 4: Day 2	1.0 percentage of cell activation Standard Deviation 2.98	0.6 percentage of cell activation Standard Deviation 2.49	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56brCD16dim,Change at Dose 4: Day 4	0.9 percentage of cell activation Standard Deviation 1.63	2.9 percentage of cell activation Standard Deviation 2.13	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56brCD16dim,Change at Dose 6: Day 1	1.9 percentage of cell activation Standard Deviation 2.09	1.5 percentage of cell activation Standard Deviation 2.90	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56brCD16dim,Change at Dose 6: Day 4	6.2 percentage of cell activation Standard Deviation 6.68	0.2 percentage of cell activation Standard Deviation 1.72	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56brCD16dim,Change at Dose 10: Day 1	5.0 percentage of cell activation Standard Deviation 7.00	1.3 percentage of cell activation Standard Deviation 1.72	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56brCD16dim,Change at Dose 10: Day 2	17.2 percentage of cell activation Standard Deviation 16.49	2.2 percentage of cell activation Standard Deviation 5.08	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56brCD16dim,Change at Dose 10: Day 4	0.0 percentage of cell activation Standard Deviation 1.46	3.3 percentage of cell activation Standard Deviation 3.70	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56brCD16dim,Change at Dose 10: Day 14	2.7 percentage of cell activation Standard Deviation 3.14	0.9 percentage of cell activation Standard Deviation 2.93	—	—	—	—
Change From Baseline in Immune Cell Activation CD69+CD56brCD16dim,Change at ATI Remission	—	0.2 percentage of cell activation Standard Deviation 0.91	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Population: 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').

Cmax is defined as the maximum concentration of drug.

Outcome measures

Measure	Vesatolimod 4 mg n=17 Participants 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.	Vesatolimod 4/6 mg 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.	Vesatolimod 6 mg 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.	Vesatolimod 6/8 mg 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.	Vesatolimod 8 mg 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.	Placebo 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.
Pharmacokinetic (PK) Parameter: Cmax of Vesatolimod	7149.6 pg/mL Standard Deviation 7662.17	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Population: Participants in the vesatolimod PK Analysis Set were analyzed. Per planned analysis this outcome measure was analyzed by actual treatment received (i.e. 'Vesatolimod').

AUClast is defined as the concentration of drug from time zero to the last observable concentration.

Outcome measures

Measure	Vesatolimod 4 mg n=17 Participants 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.	Vesatolimod 4/6 mg 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.	Vesatolimod 6 mg 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.	Vesatolimod 6/8 mg 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.	Vesatolimod 8 mg 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.	Placebo 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.
PK Parameter: AUClast of Vesatolimod	49323.5 hour*pg/ml Standard Deviation 48542.34	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Population: 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').

AUCinf was defined as the concentration of drug extrapolated to infinite time.

Outcome measures

Measure	Vesatolimod 4 mg n=16 Participants 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.	Vesatolimod 4/6 mg 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.	Vesatolimod 6 mg 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.	Vesatolimod 6/8 mg 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.	Vesatolimod 8 mg 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.	Placebo 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.
PK Parameter: AUCinf of Vesatolimod	60040.3 hour*pg/mL Standard Deviation 59280.72	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Population: 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').

%AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf.

Outcome measures

Measure	Vesatolimod 4 mg n=16 Participants 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.	Vesatolimod 4/6 mg 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.	Vesatolimod 6 mg 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.	Vesatolimod 6/8 mg 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.	Vesatolimod 8 mg 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.	Placebo 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.
PK Parameter: %AUCexp of Vesatolimod	22.4 Percentage of AUC Standard Deviation 7.90	—	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Population: 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').

Tmax is defined as the time (observed time point) of Cmax.

Outcome measures

Measure	Vesatolimod 4 mg n=16 Participants 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.	Vesatolimod 4/6 mg 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.	Vesatolimod 6 mg 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.	Vesatolimod 6/8 mg 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.	Vesatolimod 8 mg 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.	Placebo 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.
PK Parameter: Tmax of Vesatolimod	2.00 hour Interval 0.5 to 6.0	—	—	—	—	—

Adverse Events

Vesatolimod

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vesatolimod n=17 participants at risk 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.	Placebo n=8 participants at risk 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.
Gastrointestinal disorders Chronic gastritis	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.

Other adverse events

Measure	Vesatolimod n=17 participants at risk 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.	Placebo n=8 participants at risk 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.
Blood and lymphatic system disorders Lymphadenopathy	17.6% 3/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Cardiac disorders Bradycardia	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Eye disorders Blepharospasm	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain lower	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Angular cheilitis	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Chapped lips	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Faeces soft	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	29.4% 5/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	12.5% 1/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Swollen tongue	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Umbilical hernia	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	12.5% 1/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
General disorders Chills	23.5% 4/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
General disorders Fatigue	17.6% 3/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
General disorders Malaise	11.8% 2/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
General disorders Pyrexia	17.6% 3/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
General disorders Vessel puncture site bruise	11.8% 2/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Acute sinusitis	11.8% 2/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Gastroenteritis viral	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	12.5% 1/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Laryngitis	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	11.8% 2/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Sinusitis	17.6% 3/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	25.0% 2/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Tinea cruris	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Viral infection	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	12.5% 1/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Procedural pain	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Rib fracture	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Tooth fracture	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Investigations Weight decreased	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Metabolism and nutrition disorders Gout	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	17.6% 3/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	12.5% 1/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	12.5% 1/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	12.5% 1/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	12.5% 1/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Tendonitis	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Dizziness	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Headache	29.4% 5/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	37.5% 3/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Neuropathy peripheral	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Sciatica	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Pregnancy, puerperium and perinatal conditions Morning sickness	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Reproductive system and breast disorders Haematospermia	0.00% 0/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	12.5% 1/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal disorder	0.00% 0/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	12.5% 1/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	12.5% 1/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Sinus congestion	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Eczema	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Hand dermatitis	11.8% 2/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Vascular disorders Hypertension	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Vascular disorders Phlebitis	5.9% 1/17 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/8 • From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: GileadClinicalTrials@gilead.com

Results disclosure agreements

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

Restriction type: OTHER