Proof of Concept Treatment Study of Orally Administered V... | NCT06039579 | Trialant
NCT06039579
Sponsor
ViiV Healthcare
Status
Completed
Last Update Posted
Sep 30, 2025Actual
Enrollment
44Actual
Phase
Phase 2
Conditions
HIV Infections
Interventions
VH4004280
VH4011499
VH4004280 Matching Placebo
VH4011499 Matching Placebo
Antiretroviral therapy
Countries
United States
Argentina
Canada
France
Germany
Italy
Mexico
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT06039579
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
218307
Secondary IDs
ID
Type
Description
Link
2023-505350-18-00
Other Identifier
EU CT number
Brief Title
Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults
Official Title
A Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Phase 2a Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Orally Administered Investigational Capsid Inhibitor Monotherapy in HIV-1 Infected Treatment-Naïve Adults
Acronym
CINNAMON
Organization
ViiV HealthcareINDUSTRY
Status Module
Record Verification Date
Sep 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 25, 2023Actual
Primary Completion Date
Jun 24, 2024Actual
Completion Date
Jun 24, 2024Actual
First Submitted Date
Aug 23, 2023
First Submission Date that Met QC Criteria
Sep 12, 2023
First Posted Date
Sep 15, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Jun 23, 2025
Results First Submitted that Met QC Criteria
Sep 9, 2025
Results First Posted Date
Sep 30, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 9, 2025
Last Update Posted Date
Sep 30, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ViiV HealthcareINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary purpose of the study is to evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1) infected Treatment-Naïve (TN) participants.
Detailed Description
Not provided
Conditions Module
Conditions
HIV Infections
Keywords
HIV-1
VH4004280
VH4011499
Treatment Naïve
Phase 2a
Monotherapy
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
44Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1a: VH4004280 Dose Level 1
Experimental
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
Drug: VH4004280
Drug: Antiretroviral therapy
Part 1a: VH4004280 Dose Level 2
Experimental
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Drug: VH4004280
Drug: Antiretroviral therapy
Part 2a: VH4004280 pre-specified dose
Experimental
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Drug: VH4004280
Drug: Antiretroviral therapy
Matching placebo for VH4004280
Placebo Comparator
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Drug: VH4004280 Matching Placebo
Drug: Antiretroviral therapy
Part 1b: VH4011499 Dose Level 1
Interventions
Name
Type
Description
Arm Group Labels
Other Names
VH4004280
Drug
VH4004280 was administered as tablets orally at Day 1.
Part 1a: VH4004280 Dose Level 1
Part 1a: VH4004280 Dose Level 2
Part 2a: VH4004280 pre-specified dose
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The results were expressed as log10 copies per milliliter (log10 c/mL).
From Baseline (Day 1) and up to Day 11
Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
From Baseline (Day 1) and up to Day 11
Secondary Outcomes
Measure
Description
Time Frame
Monotherapy: Number of Participants With Any Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
From Baseline (Day 1) and up to Day 11
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants who are overtly healthy (other than HIV-1 infection).
Screening cluster of differentiation-4 (CD4+) T-cell count greater than or equal to (≥)200 cells/microliter (µL).
Treatment-naïve: Defined as no antiretroviral therapy received after the diagnosis of HIV-1 infection. Prior use of oral pre-exposure prophylaxis (PreP) is permitted. Prior use of parenteral PreP is exclusionary.
Has body mass index (BMI) within the range of 18.5-31.0 kilograms per meter square (kg/m^2).
Participants male at birth must use male condoms and participants female at birth who are of childbearing potential must be using acceptable forms of birth control.
Participants capable of giving signed informed consent.
Participant must be willing and able to start locally accessible and commercially available combination antiretroviral therapy after the monotherapy period.
Exclusion Criteria:
Women who are breastfeeding or plan to become pregnant or breast feed during the study.
Participants with acute HIV infection.
Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease.
Untreated syphilis infection.
Ongoing malignancy other than certain localised malignancies.
Treatment with immunomodulating agents or any agent with known anti-HIV activity.
Has exclusionary psychiatric, hepatic, cardiovascular gastrointestinal, renal condition.
Participant having any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication.
Participants having exclusionary electrocardiogram (ECG) findings.
Participants who have been exposed to any prohibited medication or vaccine.
Participant positive for hepatitis B or hepatitis C.
Participants with exclusionary safety laboratory (e.g Grade 3 or greater abnormality).
Participants who have positive results for illicit drug use, regular use of drugs of abuse and/or excessive alcohol use.
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
All participants that were enrolled started the study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
FG001
Part 1a: VH4004280 Dose Level 2
Periods
Title
Milestones
Reasons Not Completed
Monotherapy (Day 1-Day 11)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 8, 2023
Jun 23, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Experimental
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
Drug: VH4011499
Drug: Antiretroviral therapy
Part 1b: VH4011499 Dose Level 2
Experimental
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Drug: VH4011499
Drug: VH4011499 Matching Placebo
Drug: Antiretroviral therapy
Part 2b: VH4011499 pre-specified dose
Experimental
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Drug: VH4011499
Drug: Antiretroviral therapy
Matching placebo for VH4011499
Placebo Comparator
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Drug: Antiretroviral therapy
VH4011499
Drug
VH4011499 was administered as tablets orally at Day 1 and Day 6.
Part 1b: VH4011499 Dose Level 1
Part 1b: VH4011499 Dose Level 2
Part 2b: VH4011499 pre-specified dose
VH4004280 Matching Placebo
Drug
VH4004280 Matching Placebo was administered as tablets orally at Day 1.
Matching placebo for VH4004280
VH4011499 Matching Placebo
Drug
VH4011499 Matching Placebo was administered as tablets orally at Day 1 and Day 6.
Part 1b: VH4011499 Dose Level 2
Antiretroviral therapy
Drug
Antiretroviral therapy was administered as available and as per investigator's recommendation.
Matching placebo for VH4004280
Matching placebo for VH4011499
Part 1a: VH4004280 Dose Level 1
Part 1a: VH4004280 Dose Level 2
Part 1b: VH4011499 Dose Level 1
Part 1b: VH4011499 Dose Level 2
Part 2a: VH4004280 pre-specified dose
Part 2b: VH4011499 pre-specified dose
Follow-up: Number of Participants With Any AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
From Day 11 and up to Day 39
Monotherapy: Number of Participants With AEs by Severity
Severity was rated according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
From Baseline (Day 1) and up to Day 11
Follow-up: Number of Participants With AEs by Severity
Severity was rated according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
From Day 11 and up to Day 39
Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation
'Discontinuation' of study intervention refers to any participant who has not received all planned doses of study intervention.
From Baseline (Day 1) and up to Day 11
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Change from Baseline values for liver panel laboratory parameters total bilirubin and direct bilirubin were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.Standard deviation (SD) = 0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Change from Baseline values for liver panel laboratory parameters total bilirubin and direct bilirubin were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. SD = 0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
Change from Baseline values for liver panel laboratory parameters ALT, ALP and AST were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Change from Baseline values for liver panel laboratory parameters ALT, ALP and AST were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
From Baseline (Day 1) and up to Day 39
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
From Baseline (Day 1) and up to Day 39
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
From Baseline (Day 1) and up to Day 39
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
From Baseline (Day 1) and up to Day 39
Monotherapy, VH4004280: Maximum Observed Plasma Drug Concentration (Cmax)
Cmax is defined as the maximum concentration of the drug in plasma.
After dose administration at Day 1
Monotherapy, VH4011499: Cmax
Cmax is defined as the maximum concentration of the drug in plasma.
After dose administration at Day 1 and Day 6
Monotherapy, VH4004280: Time to Maximum Observed Plasma Drug Concentration (Tmax)
Tmax is a measure of the time required to reach the maximum concentration of the drug.
After dose administration at Day 1
Monotherapy, VH4011499: Tmax
Tmax is a measure of the time required to reach the maximum concentration of the drug.
After dose administration at Day 1 and Day 6
Monotherapy, VH4004280: Plasma Concentration at Day 11 (C11)
C11 is defined as the concentration of the drug in plasma at Day 11.
At Day 11
Monotherapy, VH4011499: C11
C11 is defined as the concentration of the drug in plasma at Day 11.
At Day 11
Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
At Baseline (Day 1) and Day 11
Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
At Baseline (Day 1) and Day 11
DeLand
Florida
32720
United States
GSK Investigational Site
Newark
New Jersey
07102
United States
GSK Investigational Site
Buenos Aires
1023
Argentina
GSK Investigational Site
Buenos Aires
C1202ABB
Argentina
GSK Investigational Site
Buenos Aires
C1425AGC
Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno
C1405CKC
Argentina
GSK Investigational Site
Montreal
Quebec
H2L 4P9
Canada
GSK Investigational Site
Marseille
13003
France
GSK Investigational Site
Nantes
44093
France
GSK Investigational Site
Paris
75018
France
GSK Investigational Site
Cologne
50937
Germany
GSK Investigational Site
Milan
20157
Italy
GSK Investigational Site
Guadalajara
44160
Mexico
GSK Investigational Site
Mexico City
06760
Mexico
GSK Investigational Site
Barcelona
08907
Spain
GSK Investigational Site
Barcelona
08916
Spain
GSK Investigational Site
Madrid
28034
Spain
GSK Investigational Site
Madrid
28046
Spain
GSK Investigational Site
London
SE5 8RX
United Kingdom
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
FG002
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
FG003
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
FG004
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
FG005
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
FG006
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
FG007
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0033 subjects
FG0047 subjects
FG0056 subjects
FG0067 subjects
FG0073 subjects
COMPLETED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0033 subjects
FG0047 subjects
FG0056 subjects
FG0067 subjects
FG0073 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Follow-Up (Day 11-Day 39)
Type
Comment
Milestone Data
STARTED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0033 subjects
FG0047 subjects
FG0056 subjects
FG0067 subjects
FG0073 subjects
COMPLETED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0033 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline measures are presented based on Exposed population, which included all participants that received a study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
BG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
BG002
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
BG003
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
BG004
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
BG005
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
BG006
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
BG007
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG0026
BG0033
BG0047
BG0056
BG0067
BG0073
BG00844
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
YEARS
Title
Denominators
Categories
Title
Measurements
BG00034.3± 12.82
BG00142.8± 10.3
BG00231.5± 9.75
BG003
Sex/Gender, Customized
Count of Participants
Participants
Title
Denominators
Categories
Male
Title
Measurements
BG0005
BG0015
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG002
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
Monotherapy, VH4004280: Maximum Change From Baseline (Day 1) in Plasma HIV-1 Ribonucleic Acid (RNA) log10
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The results were expressed as log10 copies per milliliter (log10 c/mL).
Analysis was performed on Full Analysis Set (FAS) population, which included all randomized participants who received at least one full dose of study treatment. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in this analysis.
Posted
Mean
Standard Deviation
log10 c/mL
From Baseline (Day 1) and up to Day 11
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG003
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Baseline (Day 1)
Title
Measurements
OG0005.004± 0.4592
OG0014.923± 0.5428
OG0024.866± 0.7696
OG003
Primary
Monotherapy, VH4011499: Maximum Change From Baseline (Day 1) in Plasma HIV-1 RNA log10
Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum change from baseline was calculated by subtracting the baseline value from the post-dose visit value when the plasma HIV-1 RNA reached its minimum level up to Day 11 (inclusive). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Analysis was performed on FAS population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in this analysis.
Posted
Mean
Standard Deviation
log10 c/mL
From Baseline (Day 1) and up to Day 11
ID
Title
Description
OG000
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
OG001
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2b: VH4011499 Pre-specified Dose
Secondary
Monotherapy: Number of Participants With Any Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
Analysis was performed on Safety Population, which included all randomized participants who received at least 1 dose of study treatment and had safety data available.
Posted
Count of Participants
Participants
From Baseline (Day 1) and up to Day 11
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Secondary
Follow-up: Number of Participants With Any AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
Analysis was performed on Safety Population.
Posted
Count of Participants
Participants
From Day 11 and up to Day 39
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Secondary
Monotherapy: Number of Participants With AEs by Severity
Severity was rated according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Analysis was performed on Safety Population.
Posted
Count of Participants
Participants
From Baseline (Day 1) and up to Day 11
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Secondary
Follow-up: Number of Participants With AEs by Severity
Severity was rated according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Analysis was performed on Safety Population.
Posted
Count of Participants
Participants
From Day 11 and up to Day 39
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG003
Secondary
Monotherapy: Number of Participants With AEs Leading to Study Treatment Discontinuation
'Discontinuation' of study intervention refers to any participant who has not received all planned doses of study intervention.
Analysis was performed on Safety Population, which included all participants that received at least one study intervention. Discontinuation of treatment was not possible for participants that received VH4004280 or matching placebo for VH4004280, since these participants received only one dose intervention at Day 1 (all planned interventions as per protocol schedule).
Posted
Count of Participants
Participants
From Baseline (Day 1) and up to Day 11
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2a: VH4004280 Pre-specified Dose
Secondary
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Change from Baseline values for liver panel laboratory parameters total bilirubin and direct bilirubin were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.Standard deviation (SD) = 0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
Analysis was performed on Safety Population. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in the analysis.
Posted
Mean
Standard Deviation
Micromole per liter (µmol/L)
At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Secondary
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Change from Baseline values for liver panel laboratory parameters total bilirubin and direct bilirubin were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value. SD = 0.0000 is defined as following: if all participants analyzed for a specific parameter at a specific time point have the same value, then SD is equal with 0.0000.
Analysis was performed on Safety Population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in the analysis.
Posted
Mean
Standard Deviation
µmol/L
At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
ID
Title
Description
OG000
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
OG001
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Secondary
Monotherapy and Follow-up, VH4004280: Change From Baseline for Liver Panel Laboratory Parameters - Alanine Aminotransferace (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
Change from Baseline values for liver panel laboratory parameters ALT, ALP and AST were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Analysis was performed on Safety Population. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in the analysis.
Posted
Mean
Standard Deviation
International units per liter (IU/L)
At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2a: VH4004280 Pre-specified Dose
Secondary
Monotherapy and Follow-up, VH4011499: Change From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Change from Baseline values for liver panel laboratory parameters ALT, ALP and AST were summarised. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Analysis was performed on Safety Population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in the analysis.
Posted
Mean
Standard Deviation
IU/L
At Baseline (Day 1) and at Days 2, 4, 6, 7, 9, 11, 18, 25, 32 and 39
ID
Title
Description
OG000
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
OG001
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2b: VH4011499 Pre-specified Dose
Secondary
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
Analysis was performed on Safety Population. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in the analysis.
Posted
Count of Participants
Participants
From Baseline (Day 1) and up to Day 39
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Secondary
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - Total Bilirubin and Direct Bilirubin
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
Analysis was performed on Safety Population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in the analysis.
Posted
Count of Participants
Participants
From Baseline (Day 1) and up to Day 39
ID
Title
Description
OG000
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
OG001
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Secondary
Monotherapy and Follow-up, VH4004280: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
Analysis was performed on Safety Population. Only participants that received VH4004280 intervention or matching placebo for VH4004280 and had data available at the specified timepoints were included in the analysis.
Posted
Count of Participants
Participants
From Baseline (Day 1) and up to Day 39
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Secondary
Monotherapy and Follow-up, VH4011499: Number of Participants With Maximum Toxicity Grade Increase From Baseline for Liver Panel Laboratory Parameters - ALT, ALP and AST
Laboratory abnormalities were graded according to DAIDS grading table Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences.
Analysis was performed on Safety Population. Only participants that received VH4011499 intervention or matching placebo for VH4011499 and had data available at the specified timepoints were included in the analysis.
Posted
Count of Participants
Participants
From Baseline (Day 1) and up to Day 39
ID
Title
Description
OG000
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
OG001
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Secondary
Monotherapy, VH4004280: Maximum Observed Plasma Drug Concentration (Cmax)
Cmax is defined as the maximum concentration of the drug in plasma.
Analysis was performed on Pharmacokinetic (PK) population, which included all participants in the Safety analysis population who had at least 1 non-missing PK assessment. Data was reported according to the actual study treatment. Only participants that received VH4004280 intervention and had data available at the specified timepoint were included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter (ng/mL)
After dose administration at Day 1
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2a: VH4004280 Pre-specified Dose
Secondary
Monotherapy, VH4011499: Cmax
Cmax is defined as the maximum concentration of the drug in plasma.
Analysis was performed on PK population. Only participants that received VH4011499 intervention and had data available at the specified timepoints were included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
After dose administration at Day 1 and Day 6
ID
Title
Description
OG000
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
OG001
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Secondary
Monotherapy, VH4004280: Time to Maximum Observed Plasma Drug Concentration (Tmax)
Tmax is a measure of the time required to reach the maximum concentration of the drug.
Analysis was performed on PK population. Only participants that received VH4004280 intervention and had data available at the specified timepoint were included in the analysis.
Posted
Median
Full Range
Hour (h)
After dose administration at Day 1
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Secondary
Monotherapy, VH4011499: Tmax
Tmax is a measure of the time required to reach the maximum concentration of the drug.
Analysis was performed on PK population. Only participants that received VH4011499 intervention and had data available at the specified timepoints were included in the analysis.
Posted
Median
Full Range
h
After dose administration at Day 1 and Day 6
ID
Title
Description
OG000
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
OG001
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Secondary
Monotherapy, VH4004280: Plasma Concentration at Day 11 (C11)
C11 is defined as the concentration of the drug in plasma at Day 11.
Analysis was performed on PK population. Only participants that received VH4004280 intervention and had data available at the specified timepoint were included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
At Day 11
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Secondary
Monotherapy, VH4011499: C11
C11 is defined as the concentration of the drug in plasma at Day 11.
Analysis was performed on PK population. Only participants that received VH4011499 intervention and had data available at the specified timepoint were included in the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
At Day 11
ID
Title
Description
OG000
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
OG001
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Secondary
Monotherapy, VH4004280: Change in Plasma HIV-1 RNA From Baseline
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Analysis was performed on FAS population. Only participants that received VH4004280 intervention and had data available at the specified timepoints were included in the analysis.
Posted
Mean
Standard Deviation
log10 c/mL
At Baseline (Day 1) and Day 11
ID
Title
Description
OG000
Part 1a: VH4004280 Dose Level 1
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
OG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Secondary
Monotherapy, VH4011499: Change in Plasma HIV-1 RNA From Baseline
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline was calculated by subtracting the baseline value from the post-dose visit value.
Analysis was performed on FAS population. Only participants that received VH4011499 intervention and had data available at the specified timepoints were included in the analysis.
Posted
Mean
Standard Deviation
log10 c/mL
At Baseline (Day 1) and Day 11
ID
Title
Description
OG000
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
OG001
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG002
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Time Frame
All-cause mortality, SAEs and non-serious AEs (including solicited and unsolicited events) were assessed from Day 1 [Monotherapy Phase] and up to Day 39 [Follow-up Phase].
Description
Adverse events are presented phase-wise (for Monotherapy and Follow-up phases), for the Exposed set, which included all participants that received at least one study dose administration.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1a: VH4004280 Dose Level 1 (Monotherapy)
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
0
6
0
6
3
6
EG001
Part 1a: VH4004280 Dose Level 2
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
0
6
0
6
2
6
EG002
Part 2a: VH4004280 Pre-specified Dose (Monotherapy)
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
0
6
0
6
2
6
EG003
Matching Placebo for VH4004280 (Monotherapy)
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
0
3
0
3
2
3
EG004
Part 1b: VH4011499 Dose Level 1 (Monotherapy)
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
0
7
0
7
2
7
EG005
Part 1b: VH4011499 Dose Level 2 (Monotherapy)
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
0
6
0
6
4
6
EG006
Part 2b: VH4011499 Pre-specified Dose (Monotherapy)
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
0
7
0
7
2
7
EG007
Matching Placebo for VH4011499 (Monotherapy)
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
0
3
0
3
1
3
EG008
Part 1a: VH4004280 Dose Level 1 (Follow-up)
Participants received a single dose of VH4004280 Dose Level 1 (low concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label antiretroviral therapy (ART) up to day 39.
0
6
0
6
1
6
EG009
Part 1a: VH4004280 Dose Level 2 (Follow-up)
Participants received a single dose of VH4004280 Dose Level 2 (medium concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
0
6
0
6
3
6
EG010
Part 2a: VH4004280 Pre-specified Dose (Follow-up)
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
0
6
0
6
4
6
EG011
Matching Placebo for VH4004280 (Follow-up)
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
0
3
0
3
1
3
EG012
Part 1b: VH4011499 Dose Level 1 (Follow-up)
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
0
7
0
7
3
7
EG013
Part 1b: VH4011499 Dose Level 2 (Follow-up)
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
0
6
0
6
3
6
EG014
Part 2b: VH4011499 Pre-specified Dose (Follow-up)
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
0
7
0
7
5
7
EG015
Matching Placebo for VH4011499 (Follow-up)
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
0
3
0
3
0
3
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
Ear pain
Ear and labyrinth disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Asthenia
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Feeling cold
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dengue fever
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Dermatophytosis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Genital herpes
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Periodontitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Transaminases increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eczema nummular
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
ViiV Healthcare agreements may vary with individual investigators, but will not prohibit any investigator from publishing. ViiV Healthcare supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG003
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0007
OG0016
OG0027
OG0033
Title
Denominators
Categories
Baseline (Day 1)
Title
Measurements
OG0005.001± 0.7304
OG0014.339± 0.6185
OG0024.960± 0.7288
OG0034.714± 0.7736
Maximum change compared to Baseline (Day 1)
Title
Measurements
OG000-1.834± 0.5141
OG001-1.797± 0.4544
OG002-2.165± 0.4310
OG003
OG003
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG004
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
OG005
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG006
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG007
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0033
OG0047
OG0056
OG0067
OG0073
Title
Denominators
Categories
Title
Measurements
OG0003
OG0012
OG0022
OG0032
OG0042
OG0054
OG0062
OG0071
OG003
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG004
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG005
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG006
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG007
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0033
OG0047
OG0056
OG0067
OG0073
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
OG0024
OG0031
OG0043
OG0053
OG0065
OG0070
OG003
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG004
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
OG005
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG006
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG007
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0033
OG0047
OG0056
OG0067
OG0073
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0000
OG0012
OG0021
OG0031
OG0041
OG0053
OG0062
OG0071
Grade 2
Title
Measurements
OG0003
OG0010
OG0021
OG003
Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 5
Title
Measurements
OG0000
OG0010
OG0020
OG003
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG004
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG005
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG006
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG007
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0033
OG0047
OG0056
OG0067
OG0073
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0042
OG0051
OG0062
OG0070
Grade 2
Title
Measurements
OG0000
OG0011
OG0023
OG003
Grade 3
Title
Measurements
OG0000
OG0011
OG0020
OG003
Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 5
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG003
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG004
Part 1b: VH4011499 Dose Level 1
Participants received a single dose of VH4011499 Dose Level 1 (low concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants had the option to switch to an open-label ART up to day 39.
OG005
Part 1b: VH4011499 Dose Level 2
Participants received a single dose of VH4011499 Dose Level 2 (medium concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG006
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG007
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0047
OG0056
OG0067
OG0073
Title
Denominators
Categories
Title
Measurements
OG0040
OG0050
OG0060
OG0070
OG002
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG003
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0033
Title
Denominators
Categories
Total Bilirubin, Baseline (Day 1)
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Title
Measurements
OG0006.641± 1.5157
OG0018.408± 5.5383
OG0026.926± 4.6300
OG003
Total Bilirubin, Day 2
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0033
Total Bilirubin, Day 4
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0033
Total Bilirubin, Day 6
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Total Bilirubin, Day 7
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Total Bilirubin, Day 9
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Total Bilirubin, Day 11
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Total Bilirubin, Day 18
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Total Bilirubin, Day 25
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Total Bilirubin, Day 32
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Total Bilirubin, Day 39
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0033
Direct Bilirubin, Baseline (Day 1)
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Direct Bilirubin, Day 2
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Direct Bilirubin, Day 4
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Direct Bilirubin, Day 6
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Direct Bilirubin, Day 7
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Direct Bilirubin, Day 9
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Direct Bilirubin, Day 11
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Direct Bilirubin, Day 18
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0033
Direct Bilirubin, Day 25
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Direct Bilirubin, Day 32
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0026
ParticipantsOG0033
Direct Bilirubin, Day 39
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
OG002
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG003
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0007
OG0016
OG0027
OG0033
Title
Denominators
Categories
Total Bilirubin, Baseline (Day 1)
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Title
Measurements
OG0005.643± 2.4898
OG0017.524± 2.6579
OG0024.544± 1.7576
OG003
Total Bilirubin, Day 2
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Total Bilirubin, Day 4
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Total Bilirubin, Day 6
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Total Bilirubin, Day 7
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Total Bilirubin, Day 9
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Total Bilirubin, Day 11
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Total Bilirubin, Day 18
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Total Bilirubin, Day 25
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Total Bilirubin, Day 32
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Total Bilirubin, Day 39
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0032
Direct Bilirubin, Baseline (Day 1)
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Direct Bilirubin, Day 2
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Direct Bilirubin, Day 4
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Direct Bilirubin, Day 6
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Direct Bilirubin, Day 7
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Direct Bilirubin, Day 9
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Direct Bilirubin, Day 11
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Direct Bilirubin, Day 18
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Direct Bilirubin, Day 25
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Direct Bilirubin, Day 32
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Direct Bilirubin, Day 39
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0032
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG003
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0033
Title
Denominators
Categories
ALT, Baseline (Day 1)
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
Title
Measurements
OG00031.3± 13.59
OG00121.7± 7.17
OG00233.2± 13.23
OG003
ALT, Day 2
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0033
ALT, Day 4
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0033
ALT, Day 6
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALT, Day 7
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALT, Day 9
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALT, Day 11
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALT, Day 18
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALT, Day 25
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALT, Day 32
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALT, Day 39
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0033
ALP, Baseline (Day 1)
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALP, Day 2
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0033
ALP, Day 4
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0033
ALP, Day 6
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALP, Day 7
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALP, Day 9
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALP, Day 11
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALP, Day 18
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALP, Day 25
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALP, Day 32
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
ALP, Day 39
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0033
AST, Baseline (Day 1)
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
AST, Day 2
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0033
AST, Day 4
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0033
AST, Day 6
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
AST, Day 7
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
AST, Day 9
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
AST, Day 11
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
AST, Day 18
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
AST, Day 25
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
AST, Day 32
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0033
AST, Day 39
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0025
ParticipantsOG0033
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG003
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0007
OG0016
OG0027
OG0033
Title
Denominators
Categories
ALT, Baseline (Day 1)
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
Title
Measurements
OG00014.9± 4.41
OG00119.5± 9.03
OG00231.7± 22.60
OG003
ALT, Day 2
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALT, Day 4
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALT, Day 6
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALT, Day 7
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALT, Day 9
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALT, Day 11
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALT, Day 18
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALT, Day 25
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALT, Day 32
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALT, Day 39
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0032
ALP, Baseline (Day 1)
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALP, Day 2
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALP, Day 4
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALP, Day 6
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALP, Day 7
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALP, Day 9
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALP, Day 11
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALP, Day 18
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALP, Day 25
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALP, Day 32
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
ALP, Day 39
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0032
AST, Baseline (Day 1)
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
AST, Day 2
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
AST, Day 4
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
AST, Day 6
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
AST, Day 7
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
AST, Day 9
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
AST, Day 11
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
AST, Day 18
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
AST, Day 25
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0033
AST, Day 32
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0027
ParticipantsOG0033
AST, Day 39
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0032
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG003
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0033
Title
Denominators
Categories
Total Bilirubin, Increase to Grade 1
Title
Measurements
OG0000
OG0011
OG0020
OG0030
Total Bilirubin, Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total Bilirubin, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total Bilirubin, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Direct Bilirubin, Increase to Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Direct Bilirubin, Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Direct Bilirubin, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Direct Bilirubin, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG003
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0007
OG0016
OG0027
OG0033
Title
Denominators
Categories
Total Bilirubin, Increase to Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Total Bilirubin, Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total Bilirubin, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Total Bilirubin, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Direct Bilirubin, Increase to Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Direct Bilirubin, Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
Direct Bilirubin, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
Direct Bilirubin, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Part 2a: VH4004280 Pre-specified Dose
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG003
Matching Placebo for VH4004280
Participants received a matching placebo for VH4004280 on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0033
Title
Denominators
Categories
ALT, Increase to Grade 1
Title
Measurements
OG0001
OG0010
OG0021
OG0030
ALT, Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0021
OG003
ALT, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP, Increase to Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP, Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Increase to Grade 1
Title
Measurements
OG0001
OG0010
OG0021
OG003
AST, Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Part 2b: VH4011499 Pre-specified Dose
Participants received a single pre-specified dose of VH4011499 (high concentration) on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
OG003
Matching Placebo for VH4011499
Participants received a matching placebo for VH4011499 on Day 1 and Day 6 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.
Units
Counts
Participants
OG0007
OG0016
OG0027
OG0033
Title
Denominators
Categories
ALT, Increase to Grade 1
Title
Measurements
OG0000
OG0010
OG0021
OG0031
ALT, Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP, Increase to Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP, Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALP, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Increase to Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
AST, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants received a single pre-specified dose of VH4004280 (high concentration) on Day 1 (evaluated for a 10-day period). On Day 11, participants switched to an open-label ART up to day 39.