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HIV-1 Capsid Inhibitor

Part 3 (Single dose): Participants receiving VH4004280 (new formulation) 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 up to day 63

Awards & highlights

Study Summary

This trialwill test a new HIV drug to see how safe & tolerable it is. It will explore single & multiple doses in healthy adults.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 63

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 63

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 63 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 and 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 VH4004280

+25 more

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 1

~80

Do I qualify?Apply below to find out

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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

360 Previous Clinical Trials

468,506 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorViiV Healthcare

3,595 Previous Clinical Trials

6,143,857 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the administration of VH4004280 for Part 2 (MAD) of this trial sanctioned by the FDA?

"The safety of Part 2 (MAD): Participants receiving VH4004280 is determined to be a 1. This assessment was made due to the Phase 1 trial status which implies limited data on efficacy and safety."

Answered by AI

Are there opportunities available for participants to join this experiment?

"As confirmed on clinicaltrials.gov, this research endeavour is currently seeking patients to participate in their trial. The project was initially posted on December 13th 2021 and the most recent update took place November 24th 2022."

Answered by AI

What criteria must participants satisfy in order to join this research program?

"This clinical trial has an age requirement of 18 to 50, with a focus on those living with human immunodeficiency virus (HIV). Approximately 80 participants will be admitted."

Answered by AI

Can individuals above the age of 20 participate in this medical trial?

"This particular clinical trial is reserved for patients between the ages of 18 and 50. Younger individuals have 108 studies available to them whereas those over 65 can explore 353 trials."

Answered by AI

What is the cap on participant numbers for this research endeavor?

"Affirmative. According to clinicaltrials.gov, the research project began recruiting participants on December 13th 2021 and is currently seeking 80 volunteers from one site. The trial was last revised on November 24th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05163522.