HIV-1 Infection
Conditions
Brief summary
The primary objectives of this study are to evaluate the safety and tolerability of escalating, multiple doses of vesatolimod (formerly GS-9620) in HIV-1 infected virologically suppressed adults on antiretroviral therapy (ART) and to evaluate the virologic effect of vesatolimod as measured by changes in plasma HIV-1 RNA.
Interventions
DRUGVesatolimod
Tablet(s) administered orally once every 2 weeks
DRUGPlacebo
Tablet(s) administered orally once every 2 weeks
DRUGARV regimen
Participants' current ARV regimen must be used in accordance with their prescribing information and may include the following: nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), raltegravir, dolutegravir, rilpivirine, and maraviroc.
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * HIV-1 infection * Aged ≥ 18 years at Pre-baseline/Day -13 * On antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to Pre-Baseline/Day -13 * The following agents are allowed as part of the current ARV regimen: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc * The following agents are NOT allowed as part of the current ARV regimen: HIV protease inhibitors (including low dose ritonavir), cobicistat-containing regimens, elvitegravir, efavirenz, etravirine, and nevirapine * A change in ARV regimen ≥ 45 days prior to baseline/Day 1 for reasons other than virologic failure (eg, tolerability, simplification, drug-drug interaction profile) is allowed * Plasma HIV-1 RNA \< 50 copies/mL at screening * Documented plasma HIV-1 RNA levels \< 50 copies/mL (according to the local assay being used) for ≥ 12 months preceding the screening visit (measured at least twice using a licensed assay with a lower limit of quantitation of at least 40 copies/mL) * Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or blip) prior to screening are acceptable. (If the lower limit of detection of the local HIV-1 RNA assay is \< 50 copies/mL, the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests) * If ART regimen is changed ≥ 60 days prior to Pre-Baseline/Day -13, plasma HIV-1 RNA \<50 copies/mL at Pre-baseline/Day -13 visit is required * No documented history of resistance to any components of the current ARV regimen * Availability of a fully active alternative ARV regimen, in the opinion of the Investigator, in the event of discontinuation of the current ARV regimen with development of resistance * Hgb ≥ 11.5 g/dL (males) or ≥ 11 g/dL (females) * White blood cells (WBC) ≥ 4,000 cells/μL * Platelets ≥ 150,000/mL * Absolute neutrophil count (ANC) ≥ 1500 cells/μL * CD4 count ≥ 400 cells/μL * Albumin ≥ 3.9 g/dL * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of the normal range (ULN) * Estimated glomerular filtration rate ≥ 60 mL/min * No autoimmune disease Key
Exclusion criteria
* Hepatitis B surface antigen (HBsAg) positive * Positive anti-HBs antibody and negative HBsAg results are acceptable * Hepatitis C antibody (HCVAb) positive * Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable * Documented history of pre-ART CD4 nadir \< 200 cells/µL * Unknown pre-ART CD4 nadir is acceptable * A new AIDS-defining condition diagnosed within 90 days prior to screening * Acute febrile illness within 35 days prior to pre-baseline/Day -13 Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days | — |
| Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint | For Cohorts 1 to 3: Baseline to Day 81; For Cohorts 4 to 6: Baseline to Day 134; For placebo: Baseline to Day 81 or Baseline to Day 134 | The maximum change from baseline in plasma Log10 HIV-1 RNA refers to the maximum change at any postdose timepoint up to Day 81 or Day 134 for placebo, Day 81 for Cohorts 1 to 3, and Day 134 for Cohorts 4 to 6. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5 | Baseline; Day 5 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 5. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8 | Baseline; Day 8 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 8. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17 | Baseline; Day 17 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 17. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11 | Baseline; Day 11 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 11. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15 | Baseline; Day 15 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 15. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19 | Baseline; Day 19 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 19. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22 | Baseline; Day 22 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 22. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25 | Baseline; Day 25 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 25. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29 | Baseline; Day 29 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 29. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31 | Baseline; Day 31 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 31. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33 | Baseline; Day 33 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 33. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36 | Baseline; Day 36 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 36 |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39 | Baseline; Day 39 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 39 |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43 | Baseline; Day 43 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 43 |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45 | Baseline; Day 45 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit pn Day 45 |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47 | Baseline; Day 47 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 47 |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50 | Baseline; Day 50 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 50. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53 | Baseline; Day 53 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 53 |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57 | Baseline; Day 57 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 57. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58 | Baseline; Day 58 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 58. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59 | Baseline; Day 59 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 59. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61 | Baseline; Day 61 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 61. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64 | Baseline; Day 64 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 64. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67 | Baseline; Day 67 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 67. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71 | Baseline; Day 71 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 71. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73 | Baseline; Day 73 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 73. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 75 | Baseline; Day 75 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 75. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78 | Baseline; Day 78 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 78. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 81 | Baseline; Day 81 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 81. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 85 | Baseline; Day 85 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 85. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 87 | Baseline; Day 87 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 87. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 92 | Baseline; Day 92 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 92. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 99 | Baseline; Day 99 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 99. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101 | Baseline; Day 101 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 101. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 106 | Baseline; Day 106 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 106. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 113 | Baseline; Day 113 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 113. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 115 | Baseline; Day 115 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 115. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 120 | Baseline; Day 120 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 120. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 127 | Baseline; Day 127 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 127. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 128 | Baseline; Day 128 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 128. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 129 | Baseline; Day 129 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 129. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 134 | Baseline; Day 134 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 134. |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 157 | Baseline; Day 157 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 157. |
| Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1 | Postdose 1 on Day 1 | — |
| Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15 | PostDose 2 on Day 15 | — |
| Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29 | PostDose 3 on Day 29 | — |
| Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43 | PostDose 4 on Day 43 | — |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2 | Baseline; Day 2 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 2. |
| Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71 | PostDose 6 on Day 71 | — |
| Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85 | PostDose 7 on Day 85 | — |
| Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99 | PostDose 8 on Day 99 | — |
| Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113 | PostDose 9 on Day 113 | — |
| Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127 | PostDose 10 on Day 127 | — |
| Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57 | PostDose 5 on Day 57 | — |
| Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3 | Baseline; Day 3 | Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 3. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at study sites in United States. The first participant was screened on 29 January 2015. The last study visit occurred on 14 February 2019.
Pre-assignment details
58 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Vesatolimod 1 mg (Cohort 1) Participants received vesatolimod 1 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | 6 |
| Vesatolimod 2 mg (Cohort 2) Participants received vesatolimod 2 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | 6 |
| Vesatolimod 4 mg (Cohort 3) Participants received vesatolimod 4 mg orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | 6 |
| Vesatolimod 6 mg (Cohort 4) Participants received vesatolimod 6 mg orally following 2-hour fast once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | 6 |
| Vesatolimod 8 mg (Cohort 5) Participants received vesatolimod 8 mg orally following overnight fasting once every 2 weeks for 127 days for a total of 10 doses, while continuing their ARV regimen in accordance their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | 6 |
| Vesatolimod 10 or 12 mg (Cohort 6) Participants received vesatolimod 10 mg orally up to Day 43 for a total of 3 doses then vesatolimod 12 mg orally up to day 127 for a total 7 doses following overnight fasting once every 2 weeks while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | 6 |
| Placebo Participants received vesatolimod placebo orally once every 2 weeks for 71 days for a total of 6 doses or 127 days for a total of 10 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | 12 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrew Consent | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Vesatolimod 1 mg (Cohort 1) | Total | Placebo | Vesatolimod 10 or 12 mg (Cohort 6) | Vesatolimod 8 mg (Cohort 5) | Vesatolimod 6 mg (Cohort 4) | Vesatolimod 4 mg (Cohort 3) | Vesatolimod 2 mg (Cohort 2) |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 11 | 46 years STANDARD_DEVIATION 10.9 | 45 years STANDARD_DEVIATION 11.9 | 47 years STANDARD_DEVIATION 17.5 | 45 years STANDARD_DEVIATION 9.9 | 44 years STANDARD_DEVIATION 9.3 | 52 years STANDARD_DEVIATION 4.8 | 45 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 43 Participants | 12 Participants | 6 Participants | 4 Participants | 6 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HIV-1 RNA | 1.28 log10 copies/mL STANDARD_DEVIATION 0 | 1.28 log10 copies/mL STANDARD_DEVIATION 0.022 | 1.28 log10 copies/mL STANDARD_DEVIATION 0 | 1.28 log10 copies/mL STANDARD_DEVIATION 0 | 1.28 log10 copies/mL STANDARD_DEVIATION 0 | 1.28 log10 copies/mL STANDARD_DEVIATION 0 | 1.30 log10 copies/mL STANDARD_DEVIATION 0.062 | 1.28 log10 copies/mL STANDARD_DEVIATION 0 |
| HIV-1 RNA Category < 50 copies/ mL | 6 Participants | 48 Participants | 12 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants |
| HIV-1 RNA Category ≥ 50 copies/ mL | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 46 Participants | 12 Participants | 6 Participants | 5 Participants | 5 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 5 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 43 Participants | 12 Participants | 5 Participants | 3 Participants | 6 Participants | 6 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 |
| other Total, other adverse events | 4 / 6 | 4 / 6 | 2 / 6 | 4 / 6 | 5 / 6 | 4 / 6 | 9 / 12 |
| serious Total, serious adverse events | 0 / 6 | 1 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 |
Outcome results
Primary
Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint
The maximum change from baseline in plasma Log10 HIV-1 RNA refers to the maximum change at any postdose timepoint up to Day 81 or Day 134 for placebo, Day 81 for Cohorts 1 to 3, and Day 134 for Cohorts 4 to 6.
Time frame: For Cohorts 1 to 3: Baseline to Day 81; For Cohorts 4 to 6: Baseline to Day 134; For placebo: Baseline to Day 81 or Baseline to Day 134
Population: The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint | 0.06 Log10 copies/mL | Standard Error 0.141 |
| Vesatolimod 2 mg (Cohort 2) | Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint | 0.01 Log10 copies/mL | Standard Error 0.018 |
| Vesatolimod 4 mg (Cohort 3) | Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint | 0.10 Log10 copies/mL | Standard Error 0.252 |
| Vesatolimod 6 mg (Cohort 4) | Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint | 0.04 Log10 copies/mL | Standard Error 0.092 |
| Vesatolimod 8 mg (Cohort 5) | Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint | 0.00 Log10 copies/mL | Standard Error 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint | 0.07 Log10 copies/mL | Standard Error 0.073 |
| Placebo | Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint | 0.42 Log10 copies/mL | Standard Error 0.729 |
p-value: 0.1498Wilcoxon rank sum test
p-value: 0.064Wilcoxon rank sum test
p-value: 0.2807Wilcoxon rank sum test
p-value: 0.1228Wilcoxon rank sum test
p-value: 0.0289Wilcoxon rank sum test
p-value: 0.5895Wilcoxon rank sum test
Primary
Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs).
Time frame: For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days
Population: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | SAEs | 0.0 percentage of participants |
| Vesatolimod 1 mg (Cohort 1) | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | AEs | 66.7 percentage of participants |
| Vesatolimod 2 mg (Cohort 2) | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | SAEs | 16.7 percentage of participants |
| Vesatolimod 2 mg (Cohort 2) | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | AEs | 66.7 percentage of participants |
| Vesatolimod 4 mg (Cohort 3) | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | SAEs | 0.0 percentage of participants |
| Vesatolimod 4 mg (Cohort 3) | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | AEs | 33.3 percentage of participants |
| Vesatolimod 6 mg (Cohort 4) | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | SAEs | 0.0 percentage of participants |
| Vesatolimod 6 mg (Cohort 4) | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | AEs | 66.7 percentage of participants |
| Vesatolimod 8 mg (Cohort 5) | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | SAEs | 0.0 percentage of participants |
| Vesatolimod 8 mg (Cohort 5) | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | AEs | 83.3 percentage of participants |
| Vesatolimod 10 or 12 mg (Cohort 6) | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | SAEs | 0.0 percentage of participants |
| Vesatolimod 10 or 12 mg (Cohort 6) | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | AEs | 66.7 percentage of participants |
| Placebo | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | SAEs | 0.0 percentage of participants |
| Placebo | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | AEs | 75.0 percentage of participants |
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 101.
Time frame: Baseline; Day 101
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101 | 0.02 Log10 copies/mL | Standard Deviation 0.049 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101 | 0.00 Log10 copies/mL | Standard Deviation 0.102 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101 | 0.05 Log10 copies/mL | Standard Deviation 0.173 |
p-value: 0.8504Wilcoxon rank sum test
p-value: 0.5716Wilcoxon rank sum test
p-value: 0.6908Wilcoxon rank sum test
p-value: 0.5186Wilcoxon rank sum test
p-value: 0.5186Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 106
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 106.
Time frame: Baseline; Day 106
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 106 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 106 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 106 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 106 | 0.10 Log10 copies/mL | Standard Deviation 0.25 |
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 11.
Time frame: Baseline; Day 11
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11 | -0.03 Log10 copies/mL | Standard Deviation 0.068 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 0.3613Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 113
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 113.
Time frame: Baseline; Day 113
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 113 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 113 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 113 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 113 | 0.09 Log10 copies/mL | Standard Deviation 0.218 |
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 115
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 115.
Time frame: Baseline; Day 115
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 115 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 115 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 115 | 0.08 Log10 copies/mL | Standard Deviation 0.156 |
p-value: 0.3074Wilcoxon rank sum test
p-value: 0.3074Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 120
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 120.
Time frame: Baseline; Day 120
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 120 | 0.04 Log10 copies/mL | Standard Deviation 0.092 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 120 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 120 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 120 | 0.01 Log10 copies/mL | Standard Deviation 0.018 |
p-value: 1Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 127
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 127.
Time frame: Baseline; Day 127
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 127 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 127 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 127 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 127 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 128
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 128.
Time frame: Baseline; Day 128
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 128 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 128 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 128 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 128 | 0.06 Log10 copies/mL | Standard Deviation 0.129 |
p-value: 0.1757Wilcoxon rank sum test
p-value: 0.1757Wilcoxon rank sum test
p-value: 0.223Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 129
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 129.
Time frame: Baseline; Day 129
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 129 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 129 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 129 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 129 | 0.03 Log10 copies/mL | Standard Deviation 0.062 |
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4652Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 134
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 134.
Time frame: Baseline; Day 134
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 134 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 134 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 134 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 134 | 0.09 Log10 copies/mL | Standard Deviation 0.215 |
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4652Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 15.
Time frame: Baseline; Day 15
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15 | -0.03 Log10 copies/mL | Standard Deviation 0.062 |
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 0.1949Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 157
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 157.
Time frame: Baseline; Day 157
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 157 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 157 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 157 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 157 | 0.13 Log10 copies/mL | Standard Deviation 0.254 |
p-value: 0.1757Wilcoxon rank sum test
p-value: 0.1757Wilcoxon rank sum test
p-value: 0.223Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 17.
Time frame: Baseline; Day 17
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17 | 0.01 Log10 copies/mL | Standard Deviation 0.117 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 19.
Time frame: Baseline; Day 19
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19 | -0.03 Log10 copies/mL | Standard Deviation 0.062 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 2.
Time frame: Baseline; Day 2
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 22.
Time frame: Baseline; Day 22
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22 | 0.02 Log10 copies/mL | Standard Deviation 0.037 |
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 0.1556Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 25.
Time frame: Baseline; Day 25
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25 | -0.03 Log10 copies/mL | Standard Deviation 0.062 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 29.
Time frame: Baseline; Day 29
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29 | 0.01 Log10 copies/mL | Standard Deviation 0.018 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29 | 0.02 Log10 copies/mL | Standard Deviation 0.112 |
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 0.1949Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 0.4278Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 3.
Time frame: Baseline; Day 3
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3 | 0.00 Log10 copies/mL | Standard Deviation 0.091 |
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3 | 0.01 Log10 copies/mL | Standard Deviation 0.034 |
p-value: 0.5557Wilcoxon rank sum test
p-value: 0.5557Wilcoxon rank sum test
p-value: 0.8288Wilcoxon rank sum test
p-value: 0.5557Wilcoxon rank sum test
p-value: 0.6056Wilcoxon rank sum test
p-value: 0.5557Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 31.
Time frame: Baseline; Day 31
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31 | -0.03 Log10 copies/mL | Standard Deviation 0.062 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31 | 0.00 Log10 copies/mL | Standard Deviation 0.014 |
p-value: 0.5186Wilcoxon rank sum test
p-value: 0.5716Wilcoxon rank sum test
p-value: 0.1869Wilcoxon rank sum test
p-value: 0.5186Wilcoxon rank sum test
p-value: 0.5186Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 33.
Time frame: Baseline; Day 33
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33 | -0.03 Log10 copies/mL | Standard Deviation 0.062 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33 | 0.01 Log10 copies/mL | Standard Deviation 0.028 |
p-value: 0.3613Wilcoxon rank sum test
p-value: 0.4237Wilcoxon rank sum test
p-value: 0.223Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 36
Time frame: Baseline; Day 36
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36 | -0.03 Log10 copies/mL | Standard Deviation 0.062 |
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36 | 0.16 Log10 copies/mL | Standard Deviation 0.5 |
p-value: 0.3456Wilcoxon rank sum test
p-value: 0.3971Wilcoxon rank sum test
p-value: 0.1301Wilcoxon rank sum test
p-value: 0.3456Wilcoxon rank sum test
p-value: 0.3456Wilcoxon rank sum test
p-value: 0.3456Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 39
Time frame: Baseline; Day 39
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39 | 0.04 Log10 copies/mL | Standard Deviation 0.19 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39 | 0.25 Log10 copies/mL | Standard Deviation 0.62 |
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4652Wilcoxon rank sum test
p-value: 0.5993Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 43
Time frame: Baseline; Day 43
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43 | -0.03 Log10 copies/mL | Standard Deviation 0.062 |
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 0.1949Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit pn Day 45
Time frame: Baseline; Day 45
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45 | -0.03 Log10 copies/mL | Standard Deviation 0.062 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 0.2763Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 47
Time frame: Baseline; Day 47
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47 | 0.07 Log10 copies/mL | Standard Deviation 0.249 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 5.
Time frame: Baseline; Day 5
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5 | -0.03 Log10 copies/mL | Standard Deviation 0.062 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 50.
Time frame: Baseline; Day 50
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50 | -0.03 Log10 copies/mL | Standard Deviation 0.062 |
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 0.1949Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 53
Time frame: Baseline; Day 53
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53 | 0.01 Log10 copies/mL | Standard Deviation 0.126 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 57.
Time frame: Baseline; Day 57
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57 | 0.03 Log10 copies/mL | Standard Deviation 0.165 |
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57 | 0.03 Log10 copies/mL | Standard Deviation 0.097 |
p-value: 0.5383Wilcoxon rank sum test
p-value: 0.5896Wilcoxon rank sum test
p-value: 0.8207Wilcoxon rank sum test
p-value: 0.5383Wilcoxon rank sum test
p-value: 0.5383Wilcoxon rank sum test
p-value: 0.5383Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 58.
Time frame: Baseline; Day 58
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 59.
Time frame: Baseline; Day 59
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59 | -0.01 Log10 copies/mL | Standard Deviation 0.081 |
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59 | 0.07 Log10 copies/mL | Standard Deviation 0.19 |
p-value: 0.3237Wilcoxon rank sum test
p-value: 0.3755Wilcoxon rank sum test
p-value: 0.4577Wilcoxon rank sum test
p-value: 0.3237Wilcoxon rank sum test
p-value: 0.3237Wilcoxon rank sum test
p-value: 0.3237Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 61.
Time frame: Baseline; Day 61
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61 | 0.01 Log10 copies/mL | Standard Deviation 0.126 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61 | 0.03 Log10 copies/mL | Standard Deviation 0.081 |
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4652Wilcoxon rank sum test
p-value: 0.7526Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 64.
Time frame: Baseline; Day 64
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64 | 0.07 Log10 copies/mL | Standard Deviation 0.154 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64 | 0.01 Log10 copies/mL | Standard Deviation 0.019 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64 | 0.07 Log10 copies/mL | Standard Deviation 0.249 |
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64 | 0.02 Log10 copies/mL | Standard Deviation 0.041 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64 | 0.02 Log10 copies/mL | Standard Deviation 0.072 |
p-value: 0.5546Wilcoxon rank sum test
p-value: 0.6937Wilcoxon rank sum test
p-value: 0.8207Wilcoxon rank sum test
p-value: 0.5383Wilcoxon rank sum test
p-value: 0.5383Wilcoxon rank sum test
p-value: 0.7878Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 67.
Time frame: Baseline; Day 67
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67 | 0.04 Log10 copies/mL | Standard Deviation 0.194 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 71.
Time frame: Baseline; Day 71
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71 | 0.02 Log10 copies/mL | Standard Deviation 0.14 |
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71 | 0.02 Log10 copies/mL | Standard Deviation 0.056 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon (Mann-Whitney)
p-value: 0.1949Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 73.
Time frame: Baseline; Day 73
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73 | 0.01 Log10 copies/mL | Standard Deviation 0.112 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73 | 0.04 Log10 copies/mL | Standard Deviation 0.136 |
p-value: 0.5186Wilcoxon rank sum test
p-value: 0.5716Wilcoxon rank sum test
p-value: 0.6908Wilcoxon rank sum test
p-value: 0.5186Wilcoxon rank sum test
p-value: 0.5186Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 75
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 75.
Time frame: Baseline; Day 75
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 75 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 75 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 75 | -0.03 Log10 copies/mL | Standard Deviation 0.062 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 75 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 78.
Time frame: Baseline; Day 78
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78 | -0.03 Log10 copies/mL | Standard Deviation 0.062 |
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78 | 0.19 Log10 copies/mL | Standard Deviation 0.635 |
p-value: 0.5383Wilcoxon rank sum test
p-value: 0.5896Wilcoxon rank sum test
p-value: 0.1784Wilcoxon rank sum test
p-value: 0.5383Wilcoxon rank sum test
p-value: 0.5383Wilcoxon rank sum test
p-value: 0.5383Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 8.
Time frame: Baseline; Day 8
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8 | -0.03 Log10 copies/mL | Standard Deviation 0.068 |
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 0.1556Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 81
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 81.
Time frame: Baseline; Day 81
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 81 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 2 mg (Cohort 2) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 81 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 4 mg (Cohort 3) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 81 | -0.03 Log10 copies/mL | Standard Deviation 0.071 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 81 | 0.00 Log10 copies/mL | Standard Deviation 0 |
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
p-value: 1Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 85
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 85.
Time frame: Baseline; Day 85
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 85 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 85 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 85 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 85 | 0.03 Log10 copies/mL | Standard Deviation 0.075 |
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 87
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 87.
Time frame: Baseline; Day 87
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 87 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 87 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 87 | 0.19 Log10 copies/mL | Standard Deviation 0.385 |
p-value: 0.3074Wilcoxon rank sum test
p-value: 0.3074Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 92
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 92.
Time frame: Baseline; Day 92
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 92 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 92 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 92 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 92 | 0.11 Log10 copies/mL | Standard Deviation 0.261 |
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
p-value: 0.4047Wilcoxon rank sum test
Secondary
Change From Baseline in Plasma Log10 HIV-1 RNA at Day 99
Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 99.
Time frame: Baseline; Day 99
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 99 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 8 mg (Cohort 5) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 99 | 0.00 Log10 copies/mL | Standard Deviation 0 |
| Vesatolimod 10 or 12 mg (Cohort 6) | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 99 | 0.03 Log10 copies/mL | Standard Deviation 0.062 |
| Placebo | Change From Baseline in Plasma Log10 HIV-1 RNA at Day 99 | 0.07 Log10 copies/mL | Standard Deviation 0.142 |
p-value: 0.1757Wilcoxon rank sum test
p-value: 0.1757Wilcoxon rank sum test
p-value: 0.5993Wilcoxon rank sum test
Secondary
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127
Time frame: PostDose 10 on Day 127
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127 | 0.0 percentage of participants |
| Vesatolimod 8 mg (Cohort 5) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127 | 0.0 percentage of participants |
| Vesatolimod 10 or 12 mg (Cohort 6) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127 | 16.7 percentage of participants |
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
Secondary
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1
Time frame: Postdose 1 on Day 1
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1 | 0.0 percentage of participants |
| Vesatolimod 2 mg (Cohort 2) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1 | 0.0 percentage of participants |
| Vesatolimod 4 mg (Cohort 3) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1 | 0.0 percentage of participants |
| Vesatolimod 6 mg (Cohort 4) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1 | 0.0 percentage of participants |
| Vesatolimod 8 mg (Cohort 5) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1 | 0.0 percentage of participants |
| Vesatolimod 10 or 12 mg (Cohort 6) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1 | 0.0 percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15
Time frame: PostDose 2 on Day 15
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15 | 0.0 percentage of participants |
| Vesatolimod 2 mg (Cohort 2) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15 | 0.0 percentage of participants |
| Vesatolimod 4 mg (Cohort 3) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15 | 0.0 percentage of participants |
| Vesatolimod 6 mg (Cohort 4) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15 | 0.0 percentage of participants |
| Vesatolimod 8 mg (Cohort 5) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15 | 0.0 percentage of participants |
| Vesatolimod 10 or 12 mg (Cohort 6) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15 | 0.0 percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29
Time frame: PostDose 3 on Day 29
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29 | 0.0 percentage of participants |
| Vesatolimod 2 mg (Cohort 2) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29 | 0.0 percentage of participants |
| Vesatolimod 4 mg (Cohort 3) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29 | 0.0 percentage of participants |
| Vesatolimod 6 mg (Cohort 4) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29 | 0.0 percentage of participants |
| Vesatolimod 8 mg (Cohort 5) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29 | 0.0 percentage of participants |
| Vesatolimod 10 or 12 mg (Cohort 6) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29 | 8.3 percentage of participants |
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
Secondary
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43
Time frame: PostDose 4 on Day 43
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43 | 0.0 percentage of participants |
| Vesatolimod 2 mg (Cohort 2) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43 | 0.0 percentage of participants |
| Vesatolimod 4 mg (Cohort 3) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43 | 16.7 percentage of participants |
| Vesatolimod 6 mg (Cohort 4) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43 | 0.0 percentage of participants |
| Vesatolimod 8 mg (Cohort 5) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43 | 0.0 percentage of participants |
| Vesatolimod 10 or 12 mg (Cohort 6) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43 | 0.0 percentage of participants |
p-value: 0.3333Fisher Exact
Secondary
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57
Time frame: PostDose 5 on Day 57
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57 | 0.0 percentage of participants |
| Vesatolimod 2 mg (Cohort 2) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57 | 0.0 percentage of participants |
| Vesatolimod 4 mg (Cohort 3) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57 | 16.7 percentage of participants |
| Vesatolimod 6 mg (Cohort 4) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57 | 0.0 percentage of participants |
| Vesatolimod 8 mg (Cohort 5) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57 | 0.0 percentage of participants |
| Vesatolimod 10 or 12 mg (Cohort 6) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57 | 9.1 percentage of participants |
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
Secondary
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71
Time frame: PostDose 6 on Day 71
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vesatolimod 1 mg (Cohort 1) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71 | 0.0 percentage of participants |
| Vesatolimod 2 mg (Cohort 2) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71 | 0.0 percentage of participants |
| Vesatolimod 4 mg (Cohort 3) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71 | 0.0 percentage of participants |
| Vesatolimod 6 mg (Cohort 4) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71 | 0.0 percentage of participants |
| Vesatolimod 8 mg (Cohort 5) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71 | 0.0 percentage of participants |
| Vesatolimod 10 or 12 mg (Cohort 6) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71 | 9.1 percentage of participants |
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
Secondary
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85
Time frame: PostDose 7 on Day 85
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85 | 0.0 percentage of participants |
| Vesatolimod 8 mg (Cohort 5) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85 | 0.0 percentage of participants |
| Vesatolimod 10 or 12 mg (Cohort 6) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85 | 16.7 percentage of participants |
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
Secondary
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99
Time frame: PostDose 8 on Day 99
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99 | 0.0 percentage of participants |
| Vesatolimod 8 mg (Cohort 5) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99 | 0.0 percentage of participants |
| Vesatolimod 10 or 12 mg (Cohort 6) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99 | 16.7 percentage of participants |
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
Secondary
Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113
Time frame: PostDose 9 on Day 113
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vesatolimod 6 mg (Cohort 4) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113 | 0.0 percentage of participants |
| Vesatolimod 8 mg (Cohort 5) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113 | 0.0 percentage of participants |
| Vesatolimod 10 or 12 mg (Cohort 6) | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113 | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113 | 0.0 percentage of participants |