| Primary | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs). | | The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). | | OG003 | 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). | | OG004 | 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). | | OG005 | 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). | | OG006 | 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). |
| | | Title | Denominators | Categories |
|---|
| SAEs | | | Title | Measurements |
|---|
| - OG0000.0
- OG00116.7
- OG0020.0
- OG003
|
|
| |
| 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. | The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug. | Posted | | Mean | Standard Error | Log10 copies/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | Vesatolimod 4 mg (Cohort 3) |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 2 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 3 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 5 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 11 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 15 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 17 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 19 | | | | ID | Title | Description |
|---|
| OG000 | Vesatolimod 1 mg (Cohort 1) | Participants received vesatolimod 1 mg tablet orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their existing ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | | OG001 | Vesatolimod 2 mg (Cohort 2) | Participants received vesatolimod 2 mg tablet orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | | OG002 | Vesatolimod 4 mg (Cohort 3) | Participants received vesatolimod 4 mg tablet orally following 2-hour fast once every 2 weeks for 71 days for a total of 6 doses while continuing their ARV regimen in accordance with their prescribing information (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 22 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 25 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 31 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 33 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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 | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 36 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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 | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 39 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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 | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 43 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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 | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 45 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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 | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 47 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 50 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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 | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 53 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 57 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 58 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 59 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 61 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 64 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 67 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 71 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 73 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 75 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 78 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 81 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 85 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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 (the following agents were allowed: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 87 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 92 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 99 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 101 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 106 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 113 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 115 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 120 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 127 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 128 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 129 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 134 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline; Day 157 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1 | | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Postdose 1 on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| Secondary | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | PostDose 2 on Day 15 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| Secondary | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | PostDose 3 on Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | PostDose 4 on Day 43 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
|
| Secondary | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | PostDose 5 on Day 57 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | PostDose 6 on Day 71 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | PostDose 7 on Day 85 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | PostDose 8 on Day 99 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | PostDose 9 on Day 113 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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| Secondary | Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | PostDose 10 on Day 127 | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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). | | OG002 | 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). |
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