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The primary objective of this study is to evaluate the safety and tolerability of a 10-dose regimen of vesatolimod in HIV-1 infected controllers on antiretroviral treatment (ART) and during analytical treatment interruption (ATI) following vesatolimod dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vesatolimod | Experimental | Participants in Period 1 will receive 10 doses of vesatolimod (4 mg to 8 mg) once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) will discontinue ART and vesatolimod and will be monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restart ART during Period 2 due to virologic rebound will complete the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who complete 24 Weeks of ATI without restarting ART will move onto Period 3 and have 2 options. They can remain off ART for up to an additional 24 weeks. Those who restart ART at the start of Period 3 will complete ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. |
|
| Placebo | Experimental | Participants in Period 1 will receive 10 doses of placebo matched to vesatolimod once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) will discontinue ART and placebo and will be monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restart ART during Period 2 due to virologic rebound will complete the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who complete 24 Weeks of ATI without restarting ART will move onto Period 3 and have 2 options. They can remain off ART for up to an additional 24 weeks. Those who restart ART at the start of Period 3 will complete ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vesatolimod | Drug | Tablets Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events (TEAEs) | AE was any untoward medical occurrence in a clinical study participant administered a medicinal product (MP), which did not necessarily had a causal relationship with treatment. AE was therefore any unfavorable and/or unintended sign, symptom, or disease temporally associated with use of MP, whether or not considered related to MP. TEAEs: AE with an onset date on or after the study drug start date and no later than 30 days after study drug stop date; or any AE leading to study drug discontinuation. TESAEs: event that resulted in following: death; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; medically important event or reaction: such events might not have been immediately life-threatening or resulted in death or hospitalization but may jeopardize participant or may require intervention to prevent one of the other outcomes constituting SAEs. | From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 | Plasma log 10 HIV-1 RNA was measured using Taqman version 2.0 assay with limit of quantification of 20 copies/mL. | Baseline and Dose 1: Days 2,8; Dose 2: Days 1,8; Dose 3: Days 1,8; Dose 4: Days 1,2,4,8; Dose 5: Day 1,8; Dose 6: Days 1,4,8; Dose 7: Days 1,8; Dose 8: Days 1,8; Dose 9: Days 1,8; Dose 10: Days 1,2,4,8,14 |
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Key Inclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mills Clinical Research | Los Angeles | California | 90069 | United States | ||
| Zuckerberg San Francisco General |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | SenGupta D, Ramgopal M, Brinson C, DeJesus E, Mills A, Shalit P, et al. Safety and Analytic Treatment Interruption Outcomes of Vesatolimod in HIV Controllers. Oral Presentation at CROI 2020, Boston, USA. Abstract 3982. |
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31 participants were screened.
Participants were enrolled at study sites in the United States. The first participant was screened on 09 May 2017. The last study visit occurred on 13 February 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vesatolimod | Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed antiretroviral treatment (ART). Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2020 | Jan 17, 2021 |
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| Placebo | Drug | Tablets Administered orally |
|
| ART | Drug | ART regimens administered in accordance with their prescribing information. The following agents are allowed as part of the ART regimen: nucleoside reverse transcriptase inhibitors, raltegravir, dolutegravir (DTG), rilpivirine, and maraviroc. |
|
| Time to Virologic Rebound | Time to virologic rebound was analyzed using the Kaplan-Meier method at two cut-off values; ≥ 50 copies/mL and ≥ 200 copies/mL. Virologic rebound at ≥ 50 copies/mL was defined as 2 consecutive HIV-1 RNA measurements ≥ 50 copies/mL. Virologic rebound at ≥ 200 copies/mL was defined as 2 consecutive HIV-1 RNA measurements ≥ 200 copies/mL. The date of rebound was the first time HIV-1 RNA measurement ≥ 50 copies/mL or ≥ 200 respectively. | From Day 1 (Period 1) up to 24 weeks of Period 2 plus 6 months following virologic re-suppression on ART, an average of 17 months |
| Peak HIV-1 Viral Load During Period 2 | For participants who did not restart ART, the maximum value of HIV-1 RNA measurements during ATI was used as the peak value and for participants who restarted ART, the maximum value of HIV-1 RNA measurements during ATI before the restart of ART was used as the peak value. | From Week 1 up to Week 24 |
| Change in Plasma Viral Load Set-Point Following ATI | Plasma viral load set-point values were calculated at pre-ART stage and following ATI. Change in plasma viral load set-point following ATI = viral set-point following ATI minus pre-ART set point. The plasma viral set-point following ATI was calculated as the geometric mean of all the HIV-1 RNA measurements between a start date and an end date. The start date and end date was provided by clinical based on blinded individual participant's data review. | Pre-ART (Initial Screening Visit) and 24 weeks plus 6 months following virologic re-suppression on ART (maximum 33 months and 5 days) |
| Change From Baseline in Levels of Serum Cytokines | Following Serum Cytokines Levels were evaluated: interferon-a (IFN-a), interleukin-1 receptor antagonist (IL-1RA), inducible protein-10 (IP-10) and inducible T cell alpha chemoattractant (ITAC). | Baseline and Dose 1: Day 2,8; Dose 4: Days 1,2,8; Dose 10: Days 1,2,8; ATI Remission Visit (12 weeks post ATI Visit: evaluated at maximum of 24 weeks); Early study drug discontinuation (7 days post- last ATI visit at Week 24) |
| Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood | Following ISGs Levels were evaluated: Interferon-stimulated Gene 15 (ISG15), Oligoadenylate synthase-1 (OAS-1), and interferon-induced guanosine triphosphate-binding protein MX1. Fold change was calculated as postbaseline value divided by baseline value. | Baseline and Dose 1: Day 2; Dose 4: Days 1,2; Dose 10: Day 1,2; Early Study Drug Discontinuation (7 days post- last ATI visit at Week 24) |
| Change From Baseline in Immune Cell Activation | Activation of Immune cells (T cells: CD4/CD38/HLADR, CD8/CD38/HLADR and NK cells: CD69+CD56+CD16+, CD69+CD56dimCD16neg, CD69+CD56brCD16dim) was measured by cytometry. | Baseline and Dose 4: Days 1,2,4; Dose 6: Days 1,4; Dose 10: Days 1,2,4,14; ATI Remission Visit (12 weeks post ATI Visit: evaluated at maximum of 24 weeks) |
| Pharmacokinetic (PK) Parameter: Cmax of Vesatolimod | Cmax is defined as the maximum concentration of drug. | Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit. |
| PK Parameter: AUClast of Vesatolimod | AUClast is defined as the concentration of drug from time zero to the last observable concentration. | Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit. |
| PK Parameter: AUCinf of Vesatolimod | AUCinf was defined as the concentration of drug extrapolated to infinite time. | Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit. |
| PK Parameter: %AUCexp of Vesatolimod | %AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf. | Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit. |
| PK Parameter: Tmax of Vesatolimod | Tmax is defined as the time (observed time point) of Cmax. | Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit. |
| San Francisco |
| California |
| 94110 |
| United States |
| Midway Immunology & Research Center | Ft. Pierce | Florida | 34982 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| Peter Shalit, MD | Seattle | Washington | 98104 | United States |
| FG001 | Placebo | Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. |
| COMPLETED |
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| NOT COMPLETED |
|
|
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vesatolimod | Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. |
| BG001 | Placebo | Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| HIV-1 RNA | Mean | Standard Deviation | log10 copies/mL |
| |||||||||||||||
| HIV-1 RNA Category | Count of Participants | Participants | No |
| |||||||||||||||
| Pre-ART Plasma Viral Set-point | Mean | Standard Deviation | log10 copies/mL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events (TEAEs) | AE was any untoward medical occurrence in a clinical study participant administered a medicinal product (MP), which did not necessarily had a causal relationship with treatment. AE was therefore any unfavorable and/or unintended sign, symptom, or disease temporally associated with use of MP, whether or not considered related to MP. TEAEs: AE with an onset date on or after the study drug start date and no later than 30 days after study drug stop date; or any AE leading to study drug discontinuation. TESAEs: event that resulted in following: death; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; medically important event or reaction: such events might not have been immediately life-threatening or resulted in death or hospitalization but may jeopardize participant or may require intervention to prevent one of the other outcomes constituting SAEs. | The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug. Per planned analysis, this outcome measure was analyzed by vesatolimod dose level and placebo. | Posted | Number | percentage of participants | From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days) |
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| Secondary | Change From Baseline in Plasma Log 10 HIV-1 RNA by Taqman 2.0 | Plasma log 10 HIV-1 RNA was measured using Taqman version 2.0 assay with limit of quantification of 20 copies/mL. | Participants in the Full Analysis Set (included all participants who were randomized into the study and received at least one dose of study drug) with available data were analyzed. | Posted | Mean | Standard Deviation | Log10 copies/mL | Baseline and Dose 1: Days 2,8; Dose 2: Days 1,8; Dose 3: Days 1,8; Dose 4: Days 1,2,4,8; Dose 5: Day 1,8; Dose 6: Days 1,4,8; Dose 7: Days 1,8; Dose 8: Days 1,8; Dose 9: Days 1,8; Dose 10: Days 1,2,4,8,14 |
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| Secondary | Time to Virologic Rebound | Time to virologic rebound was analyzed using the Kaplan-Meier method at two cut-off values; ≥ 50 copies/mL and ≥ 200 copies/mL. Virologic rebound at ≥ 50 copies/mL was defined as 2 consecutive HIV-1 RNA measurements ≥ 50 copies/mL. Virologic rebound at ≥ 200 copies/mL was defined as 2 consecutive HIV-1 RNA measurements ≥ 200 copies/mL. The date of rebound was the first time HIV-1 RNA measurement ≥ 50 copies/mL or ≥ 200 respectively. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Median | Inter-Quartile Range | weeks | From Day 1 (Period 1) up to 24 weeks of Period 2 plus 6 months following virologic re-suppression on ART, an average of 17 months |
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| Secondary | Peak HIV-1 Viral Load During Period 2 | For participants who did not restart ART, the maximum value of HIV-1 RNA measurements during ATI was used as the peak value and for participants who restarted ART, the maximum value of HIV-1 RNA measurements during ATI before the restart of ART was used as the peak value. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Median | Inter-Quartile Range | Log10 copies/mL | From Week 1 up to Week 24 |
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| Secondary | Change in Plasma Viral Load Set-Point Following ATI | Plasma viral load set-point values were calculated at pre-ART stage and following ATI. Change in plasma viral load set-point following ATI = viral set-point following ATI minus pre-ART set point. The plasma viral set-point following ATI was calculated as the geometric mean of all the HIV-1 RNA measurements between a start date and an end date. The start date and end date was provided by clinical based on blinded individual participant's data review. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Median | Inter-Quartile Range | Log10 copies/mL | Pre-ART (Initial Screening Visit) and 24 weeks plus 6 months following virologic re-suppression on ART (maximum 33 months and 5 days) |
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| Secondary | Change From Baseline in Levels of Serum Cytokines | Following Serum Cytokines Levels were evaluated: interferon-a (IFN-a), interleukin-1 receptor antagonist (IL-1RA), inducible protein-10 (IP-10) and inducible T cell alpha chemoattractant (ITAC). | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Dose 1: Day 2,8; Dose 4: Days 1,2,8; Dose 10: Days 1,2,8; ATI Remission Visit (12 weeks post ATI Visit: evaluated at maximum of 24 weeks); Early study drug discontinuation (7 days post- last ATI visit at Week 24) |
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| Secondary | Fold Change in Messenger Ribonucleic Acid (mRNA) of Interferon-Stimulated Genes (ISGs) in Whole Blood | Following ISGs Levels were evaluated: Interferon-stimulated Gene 15 (ISG15), Oligoadenylate synthase-1 (OAS-1), and interferon-induced guanosine triphosphate-binding protein MX1. Fold change was calculated as postbaseline value divided by baseline value. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | fold change | Baseline and Dose 1: Day 2; Dose 4: Days 1,2; Dose 10: Day 1,2; Early Study Drug Discontinuation (7 days post- last ATI visit at Week 24) |
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| Secondary | Change From Baseline in Immune Cell Activation | Activation of Immune cells (T cells: CD4/CD38/HLADR, CD8/CD38/HLADR and NK cells: CD69+CD56+CD16+, CD69+CD56dimCD16neg, CD69+CD56brCD16dim) was measured by cytometry. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage of cell activation | Baseline and Dose 4: Days 1,2,4; Dose 6: Days 1,4; Dose 10: Days 1,2,4,14; ATI Remission Visit (12 weeks post ATI Visit: evaluated at maximum of 24 weeks) |
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| Secondary | Pharmacokinetic (PK) Parameter: Cmax of Vesatolimod | Cmax is defined as the maximum concentration of drug. | The vesatolimod PK Analysis Set included all participants who were randomized into the study, received at least 1 dose of active vesatolimod, and had at least 1 non-missing post baseline concentration value for vesatolimod. Per planned analysis this outcome measure was analyzed by actual treatment received (i.e. 'Vesatolimod'). | Posted | Mean | Standard Deviation | pg/mL | Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit. |
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| Secondary | PK Parameter: AUClast of Vesatolimod | AUClast is defined as the concentration of drug from time zero to the last observable concentration. | Participants in the vesatolimod PK Analysis Set were analyzed. Per planned analysis this outcome measure was analyzed by actual treatment received (i.e. 'Vesatolimod'). | Posted | Mean | Standard Deviation | hour*pg/ml | Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit. |
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| Secondary | PK Parameter: AUCinf of Vesatolimod | AUCinf was defined as the concentration of drug extrapolated to infinite time. | Participants in the vesatolimod PK Analysis Set with available data were analyzed. Per planned analysis this outcome measure was analyzed by actual treatment received (i.e. 'Vesatolimod'). | Posted | Mean | Standard Deviation | hour*pg/mL | Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit. |
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| Secondary | PK Parameter: %AUCexp of Vesatolimod | %AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf. | Participants in the vesatolimod PK Analysis Set with available data were analyzed. Per planned analysis this outcome measure was analyzed by actual treatment received (i.e. 'Vesatolimod'). | Posted | Mean | Standard Deviation | Percentage of AUC | Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit. |
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| Secondary | PK Parameter: Tmax of Vesatolimod | Tmax is defined as the time (observed time point) of Cmax. | Participants in the vesatolimod PK Analysis Set with available data were analyzed. Per planned analysis this outcome measure was analyzed by actual treatment received (i.e. 'Vesatolimod'). | Posted | Median | Full Range | hour | Pre-dose (≤ 5 minutes prior to dosing), 0.5, 1, 2, 4, 6, 8, 10, and 24 hours post dose at Dose 1-Day 1 visit. |
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From first dose up to 30 days after permanent discontinuation of study drug (assessed maximum up to 33 months and 5 days)
The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vesatolimod | Participants in Period 1 received 10 doses of vesatolimod (4 mg to 8 mg) tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. | 0 | 17 | 1 | 17 | 16 | 17 |
| EG001 | Placebo | Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. | 0 | 8 | 0 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic gastritis | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Angular cheilitis | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Chapped lips | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Swollen tongue | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Vessel puncture site bruise | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Morning sickness | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
| |
| Haematospermia | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nasal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 5, 2019 | Jan 17, 2021 | Prot_001.pdf |
| ID | Term |
|---|---|
| C582524 | vesatolimod |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ≥ 50 copies/mL |
|
| OG003 | Vesatolimod 6/8 mg | Participants in Period 1 received 10 doses of vesatolimod 6 mg or 8 mg tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. |
| OG004 | Vesatolimod 8 mg | Participants in Period 1 received 10 doses of vesatolimod 8 mg tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and vesatolimod and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. |
| OG005 | Placebo | Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. |
| TEAEs |
|
Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
|
|
|
Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. |
|
|
|
|
|
|
| Placebo |
Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months. |
|
|
|
|
|
|
Participants in Period 1 received 10 doses of placebo matched to vesatolimod tablets once every 14 days over a 20-week period along with their prescribed ART. Participants in Period 2 (ATI) discontinued ART and placebo and were monitored for rebound in HIV-1 plasma viremia for 24 weeks. Participants who restarted ART during Period 2 due to virologic rebound completed the ART Re-Initiation Visits, and then Post-ART Re-suppression Visits monthly for 6 additional months. Participants who completed 24 Weeks of ATI without restarting ART moved onto Period 3 and had 2 options. They remained off ART for up to an additional 24 weeks. Those who restarted ART at the start of Period 3 completed ART Re-initiation Visits and then Post-ART Re-suppression Visits monthly for 6 additional months.
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| Participants |
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