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A Randomized, Double-Blind (Sponsor Unblinded), Placebo-Controlled, Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH4524184 in HIV-1 Infected Treatment Naïve Adults

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507173-18-00
Acronym
218806
Enrollment
11
Registered
2024-04-01
Start date
2024-04-09
Completion date
2024-07-11
Last updated
2024-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

Maximum Change from Baseline in logarithm in 10 base (log10) Plasma HIV-1 Ribonucleic Acid (RNA) Through Day 10

Detailed description

Number of Participants with Adverse Events (AEs), Number of Participants with AEs by severity, Number of Participants with AEs Leading to Study Treatment Discontinuation, Change from Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ASP) (International units per liter), Change from Baseline for Liver Panel Laboratory Parameters: Total bilirubin, Direct bilirubin (Micromoles per liter [umol/L]), Change from Baseline for Liver Panel Laboratory Parameters: Albumin and Total Protein (Grams per liter [g/L]), Percentage of Participants with Maximum Toxicity Grade Increase Relative to Baseline in liver panel laboratory parameters: ALT, AST, total bilirubin, direct bilirubin, alkaline phosphatase, albumin and total protein, Maximum Observed Plasma Drug Concentration (Cmax) of VH4524184, Time to Maximum Observed Plasma Drugs Concentration (tmax) of VH4524184, Plasma Concentration of VH4524184 on Day 10, Correlation of VH4524184 PK Parameters with Maximum Plasma HIV-1 RNA change from baseline through Day 10, Number of Participants with Treatment-emergent Genotypic Resistance, Number of Participants with Treatment-emergent Phenotypic Resistance, Change From Baseline in Cluster of Differentiation 4 (CD4+) T-cell Counts at Day 10

Interventions

DRUGVisual match to product

Sponsors

Viiv Healthcare UK Limited, Viiv Healthcare UK Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Maximum Change from Baseline in logarithm in 10 base (log10) Plasma HIV-1 Ribonucleic Acid (RNA) Through Day 10

Secondary

MeasureTime frame
Number of Participants with Adverse Events (AEs), Number of Participants with AEs by severity, Number of Participants with AEs Leading to Study Treatment Discontinuation, Change from Baseline for Liver Panel Laboratory Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ASP) (International units per liter), Change from Baseline for Liver Panel Laboratory Parameters: Total bilirubin, Direct bilirubin (Micromoles per liter [umol/L]), Change from Baseline for Liver Panel Laboratory Parameters: Albumin and Total Protein (Grams per liter [g/L]), Percentage of Participants with Maximum Toxicity Grade Increase Relative to Baseline in liver panel laboratory parameters: ALT, AST, total bilirubin, direct bilirubin, alkaline phosphatase, albumin and total protein, Maximum Observed Plasma Drug Concentration (Cmax) of VH4524184, Time to Maximum Observed Plasma Drugs Concentration (tmax) of VH4524184, Plasma Concentration of VH4524184 on Day 10, Correl

Countries

Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026