| Primary | Maximum Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA). | Plasma samples were collected for the quantitative analysis of plasma HIV-1 RNA. The maximum change from baseline was calculated by determining the largest change from baseline value across all assessment timepoints. This is identified by subtracting the lowest post-dose visit value up to Day 8 (inclusive) from the baseline value. The baseline was defined as the most recent pre-dose assessment with a valid, non-missing value, including measurements from any unscheduled visits. | The analysis was performed on the full analysis set (FAS) which included all randomized participants who received at least one full dose of study treatment. Only participants with data available at the specified timepoints were included in this analysis. | Posted | | Mean | Standard Deviation | copies/milliliter (c/mL) | | From Day 1 to Day 8 | | | | ID | Title | Description |
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| OG000 | VH3739937 Low Dose Group | Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25. | | OG001 | VH3739937 Medium Dose Group | Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. | | OG002 | VH3739937 High Dose Group | Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. | | OG003 | Placebo Once Daily (QD) | Participants received Placebo QD from Day 1 through Day 7. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. | | OG004 | Placebo Single Dose (SD) | Participants received Placebo SD on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-116909.43± 187489.611
- OG001-130461.67± 106486.489
- OG002-126026.67± 190725.475
- OG003
|
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) During Study Intervention Period | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. | The analysis was performed on the safety set which included all randomized participants who took at least 1 partial or full dose of study treatment. Only participants with data available at the specified timepoints were included in this analysis. | Posted | | Count of Participants | | Participants | | From Day 1 to Day 8 | | | | ID | Title | Description |
|---|
| OG000 | VH3739937 Low Dose Group | Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25. | | OG001 | VH3739937 Medium Dose Group | Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | Number of Reported Deaths | | The analysis was performed on the safety set. Only participants with data available at the specified timepoints were included in this analysis. | Posted | | Count of Participants | | Participants | | From Day 1 to Day 8 | | | | ID | Title | Description |
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| OG000 | VH3739937 Low Dose Group | Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25. | | OG001 | VH3739937 Medium Dose Group | Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. | | OG002 | VH3739937 High Dose Group | Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | Number of Participants With Adverse Events (AEs) Leading to Discontinuation | An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have discontinued from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of last contact. | The analysis was performed on the safety set. Only participants with data available at the specified timepoints were included in this analysis. | Posted | | Count of Participants | | Participants | | From Day 1 to Day 8 | | | | ID | Title | Description |
|---|
| OG000 | VH3739937 Low Dose Group | Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25. | | OG001 | VH3739937 Medium Dose Group | Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of VH3739937 on QD Dosing | Blood samples were collected at indicated timepoints for PK analysis. | The analysis was performed on the Pharmacokinetic (PK) set which included all participants in the Safety analysis set who had at least 1 PK assessment. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | VH3739937 Low Dose Group | Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25. | | OG001 | VH3739937 Medium Dose Group | Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | Time to Maximum Concentration (Tmax) of VH3739937 on QD Dosing | Blood samples were collected at indicated timepoints for PK analysis. Tmax is defined as the time to reach maximum observed plasma concentration (Cmax). | The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | | Median | Full Range | hour (h) | | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | VH3739937 Low Dose Group | Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25. | | OG001 | VH3739937 Medium Dose Group | Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | Concentration at 24 Hours (C24) Post Dose of VH3739937 on QD Dosing | C24 is defined as concentration at nominal time of 24 hours after dosing. Blood samples were collected at indicated timepoints for PK analysis. | The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | | Mean | Standard Deviation | ng/mL | | At 24h post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | VH3739937 Low Dose Group | Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25. | | OG001 | VH3739937 Medium Dose Group | Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | Area Under the Concentration-time Curve From Zero to 24h (AUC[0-24]) of VH3739937 on QD Dosing. | Blood samples were collected at indicated timepoints for PK analysis. | The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour nanogram per milliliter (h*ng/mL) | | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | VH3739937 Low Dose Group | Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25. | | OG001 | VH3739937 Medium Dose Group | Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | Cmax of VH3739937 at Steady State (Cmax, ss) on QD Dosing | Blood samples were collected at indicated timepoints for PK analysis. | The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 7 | | | | ID | Title | Description |
|---|
| OG000 | VH3739937 Low Dose Group | Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25. | | OG001 | VH3739937 Medium Dose Group | Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | Tmax of VH3739937 at Steady State (Tmax, ss) on QD Dosing | Blood samples were collected at indicated timepoints for PK analysis. Tmax is defined as the time to reach the maximum observed plasma concentration (Cmax). | The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | | Median | Full Range | hour (h) | | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h post-dose on Day 7 | | | | ID | Title | Description |
|---|
| OG000 | VH3739937 Low Dose Group | Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25. | | OG001 | VH3739937 Medium Dose Group | Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | C24 of VH3739937 at Steady State (C24, ss) on QD Dosing | Blood samples were collected at indicated timepoints for PK analysis. | The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | | Mean | Standard Deviation | ng/mL | | At 24h post-dose on Day 7 | | | | ID | Title | Description |
|---|
| OG000 | VH3739937 Low Dose Group | Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25. | | OG001 | VH3739937 Medium Dose Group | Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | AUC(0-24) of VH3739937 at Steady State (AUC[0-24], ss) on QD Dosing | Blood samples were collected at indicated timepoints for PK analysis. | The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h post-dose on Day 7 | | | | ID | Title | Description |
|---|
| OG000 | VH3739937 Low Dose Group | Participants received a low dose of VH3739937 as loading Dose 1 (LD1) on Day 1, followed by a once-daily (QD) dose of VH3739937 as maintenance Dose 1 (MD1) from Days 2 through 7, where MD1 was lower than LD1. On Day 8, all participants transitioned to standard-of-care (SOC) combination antiretroviral therapy (cART) and continued study assessments through Day 25. | | OG001 | VH3739937 Medium Dose Group | Participants received a medium dose of VH3739937 as loading Dose 2 (LD2) on Day 1, followed by a QD dose of VH3739937 as maintenance Dose 2 (MD2) from Days 2 through 7, where MD2 was lower than LD2. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | Cmax Post Single Dose of VH3739937 | Blood samples were collected at indicated timepoints for PK analysis. | The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1) | | | | ID | Title | Description |
|---|
| OG000 | VH3739937 High Dose Group | Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | Tmax Post Single Dose of VH3739937 | Blood samples were collected at indicated timepoints for PK analysis. | The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | | Median | Full Range | hour (h) | | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1) | | | | ID | Title | Description |
|---|
| OG000 | VH3739937 High Dose Group | Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | Concentration at 168 Hours (C168) Post Single Dose of VH3739937 | C168 is defined as concentration of VH3739937 at a nominal time of 168 hours after dosing. Blood samples were collected at indicated timepoints for PK analysis. | The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | At 168 hours post-dose (single dose administered on Day 1) | | | | ID | Title | Description |
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| OG000 | VH3739937 High Dose Group | Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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| Secondary | Area Under the Concentration-time Curve From Zero to 168h [AUC(0-168)] Post Single Dose of VH3739937 | Blood samples were collected at indicated timepoints for analysis. | The analysis was performed on the PK set. Only participants with data available at the mentioned timepoints were included in this analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Pre-dose, 1 hour (h), 2 h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h post-dose (single dose administered on Day 1) | | | | ID | Title | Description |
|---|
| OG000 | VH3739937 High Dose Group | Participants received a single high dose (Dose 3) of VH3739937 on Day 1. On Day 8, all participants transitioned to SOC cART and continued study assessments through Day 25. |
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