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HIV-1 Capsid Inhibitor

VH4011499 for Human Immunodeficiency Virus Infection

Phase 1
Waitlist Available
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and up to day 42
Awards & highlights

Summary

This trial is testing a new HIV drug called VH4011499 in healthy adults. The drug aims to block a key part of the virus to stop it from working. The study will check if the drug is safe and how the body handles it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and up to day 42
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and up to day 42 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Absolute values of liver panel parameters: Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST) (International units per Liter)
Part 1: Absolute values of liver panel parameters: Direct bilirubin, total bilirubin (Micromoles per liter)
Part 1: Area under the plasma concentration time curve from time zero to infinity (AUC[0-infinity]) following single dose administration of VH4011499
+25 more

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 3 (Single dose): Participants receiving VH4011499 (new formulation)Experimental Treatment1 Intervention
Group II: Part 2 (MAD) Non DDI cohort: Participants receiving VH4011499Experimental Treatment1 Intervention
Group III: Part 2 (MAD) Drug-Drug Interaction (DDI) cohort: Participants receiving VH4011499 + MidazolamExperimental Treatment2 Interventions
Group IV: Part 1 (SAD): Participants receiving VH4011499Experimental Treatment1 Intervention
Group V: Part 1 (SAD): Participants receiving placeboPlacebo Group1 Intervention
Group VI: Part 2 (MAD) DDI cohort: Participants receiving placebo + MidazolamPlacebo Group2 Interventions
Group VII: Part 2 (MAD) Non DDI cohort: Participants receiving placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VH4011499
2022
Completed Phase 1
~80
Midazolam
2018
Completed Phase 4
~1910

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
363 Previous Clinical Trials
468,915 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,596 Previous Clinical Trials
6,144,207 Total Patients Enrolled
~22 spots leftby Sep 2025
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