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HIV-1 Capsid Inhibitor

First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants

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 up to 5 years

Summary

This trial is testing a new HIV drug called VH4004280 in healthy adults to see if it is safe and how it is processed by the body. The drug works by blocking a crucial part of the HIV virus.

Eligible Conditions
  • Human Immunodeficiency Virus (HIV) Infection
  • HIV Suppression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 3 (Single dose): Participants receiving VH4004280 (new formulation)Experimental Treatment1 Intervention
Group II: Part 2 (MAD) Non Drug-Drug Interaction (DDI) cohort: Participants receiving VH4004280Experimental Treatment1 Intervention
Group III: Part 2 (MAD) DDI cohort: Participants receiving VH4004280 and MidazolamExperimental Treatment2 Interventions
Group IV: Part 1 (SAD): Participants receiving VH4004280Experimental Treatment1 Intervention
Group V: Part 1 (SAD): Participants receiving placeboPlacebo Group1 Intervention
Group VI: Part 2 (MAD) DDI cohort: Participants receiving Placebo and 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
Midazolam
2018
Completed Phase 4
~1910
VH4004280
2021
Completed Phase 2
~120

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
373 Previous Clinical Trials
470,340 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,605 Previous Clinical Trials
6,144,998 Total Patients Enrolled
~18 spots leftby Dec 2025
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