Part 1: Cohort 1: Participants receiving VH4524184 DL1 for Human Immunodeficiency Virus (HIV) Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
GSK Investigational Site, Baltimore, MDHuman Immunodeficiency Virus (HIV) InfectionVH4524184 - Drug
Eligibility
18 - 50
All Sexes
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Study Summary

This trial tests a new drug to see if it's safe and how it affects the body, with the potential to modify how other drugs work.

Treatment Effectiveness

Study Objectives

32 Primary · 3 Secondary · Reporting Duration: Baseline (Day 1) and up to 6.5 weeks

Week 4
Part 1: Change from Baseline in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline phosphatase (ALP) (International units per liter)
Part 1: Change from Baseline in International normalized ratio (INR) (Ratio)
Part 1: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Part 1: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Part 1: Number of participants with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR
Week 5
Part 2: Change from Baseline in AST, ALT and ALP (International units per liter)
Part 2: Change from Baseline in INR (Ratio)
Part 2: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Part 2: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Part 2: Number of participants with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR
Part 3: Change from Baseline in AST, ALT and ALP (International units per liter)
Part 3: Change from Baseline in INR (Ratio)
Part 3: Change from Baseline in Prothrombin time and Partial Thromboplastin Time (Seconds)
Part 3: Change from Baseline in Total bilirubin and Direct bilirubin (Micromoles per liter)
Part 3: Number of participant with maximum toxicity grade increase from Baseline in liver panel laboratory parameters; AST, ALT, ALP, Total bilirubin, Direct bilirubin, Prothrombin time, Partial Thromboplastin Time and INR
Up to 4 weeks
Part 1: Apparent terminal half-life (t1/2) following dosing of VH4524184
Part 1: Area under the plasma-concentration time curve from zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) following dosing of VH4524184
Part 1: Maximum observed plasma drug concentration (Cmax) following dosing of VH4524184
Part 1: Number of participants with adverse events based on severity
Part 1: Number of participants with serious adverse events (SAE) and non-serious adverse events (non-SAE)
Part 1: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Part 1: Percentage of participants who discontinue treatment due to adverse events (AE)
Part 1: Time to maximum observed plasma drug concentration (tmax) following dosing of VH4524184
Up to 6.5 weeks
Part 2: Area under the plasma concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tau]) following dosing of VH4524184
Part 2: Cmax following dosing of VH4524184
Part 2: Number of participants with SAE and non-SAE
Part 2: Number of participants with adverse events by severity
Part 2: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Part 2: Percentage of participants who discontinue treatment due to AE
Part 2: T1/2 following dosing of VH4524184
Part 2: Tmax following dosing of VH4524184
Part 3: Number of participants with SAE and non-SAE
Part 3: Number of participants with adverse events based on severity
Part 3: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Part 3: Percentage of participants who discontinue treatment due to AE

Trial Safety

Trial Design

19 Treatment Groups

Part 1: Cohort 1: Participants receiving VH4524184 DL1
1 of 19
Part 1: Cohort 3: Participants receiving VH4524184 DL3
1 of 19
Part 1: Cohort 4: Participants receiving VH4524184 DL4
1 of 19
Part 3: Cohort 10: VH4524184 Fasted/ VH4524184 Fed
1 of 19
Part 1: Cohort 2: Participants receiving VH4524184 DL2
1 of 19
Part 1: Cohort 6: Participants receiving VH4524184 DL6
1 of 19
Part 2: Cohort 8: Participants receiving VH4524184 RL2
1 of 19
Part 2: Cohort 9: Participants receiving VH4524184 RL3
1 of 19
Part 2: Cohort 7: Participants receiving VH4524184 RL1
1 of 19
Part 1: Cohort 5: Participants receiving VH4524184 DL5
1 of 19
Part 1: Cohort 6: Participants receiving Placebo
1 of 19
Part 2: Cohort 9: Participants receiving Placebo
1 of 19
Part 1: Cohort 2: Participants receiving Placebo
1 of 19
Part 1: Cohort 4: Participants receiving Placebo
1 of 19
Part 1: Cohort 5: Participants receiving Placebo
1 of 19
Part 2: Cohort 7: Participants receiving Placebo
1 of 19
Part 1: Cohort 3: Participants receiving Placebo
1 of 19
Part 1: Cohort 1: Participants receiving Placebo
1 of 19
Part 2: Cohort 8: Participants receiving Placebo
1 of 19

Experimental Treatment

Non-Treatment Group

105 Total Participants · 19 Treatment Groups

Primary Treatment: Part 1: Cohort 1: Participants receiving VH4524184 DL1 · Has Placebo Group · Phase 1

Part 1: Cohort 1: Participants receiving VH4524184 DL1
Drug
Experimental Group · 1 Intervention: VH4524184 · Intervention Types: Drug
Part 1: Cohort 3: Participants receiving VH4524184 DL3
Drug
Experimental Group · 1 Intervention: VH4524184 · Intervention Types: Drug
Part 1: Cohort 4: Participants receiving VH4524184 DL4
Drug
Experimental Group · 1 Intervention: VH4524184 · Intervention Types: Drug
Part 3: Cohort 10: VH4524184 Fasted/ VH4524184 Fed
Drug
Experimental Group · 1 Intervention: VH4524184 · Intervention Types: Drug
Part 1: Cohort 2: Participants receiving VH4524184 DL2
Drug
Experimental Group · 1 Intervention: VH4524184 · Intervention Types: Drug
Part 1: Cohort 6: Participants receiving VH4524184 DL6
Drug
Experimental Group · 1 Intervention: VH4524184 · Intervention Types: Drug
Part 2: Cohort 8: Participants receiving VH4524184 RL2Experimental Group · 2 Interventions: VH4524184, Midazolam · Intervention Types: Drug, Drug
Part 2: Cohort 9: Participants receiving VH4524184 RL3Experimental Group · 2 Interventions: VH4524184, Midazolam · Intervention Types: Drug, Drug
Part 2: Cohort 7: Participants receiving VH4524184 RL1
Drug
Experimental Group · 1 Intervention: VH4524184 · Intervention Types: Drug
Part 1: Cohort 5: Participants receiving VH4524184 DL5
Drug
Experimental Group · 1 Intervention: VH4524184 · Intervention Types: Drug
Part 1: Cohort 6: Participants receiving Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Part 2: Cohort 9: Participants receiving PlaceboPlaceboComparator Group · 2 Interventions: Placebo, Midazolam · Intervention Types: Drug, Drug
Part 1: Cohort 2: Participants receiving Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Part 1: Cohort 4: Participants receiving Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Part 1: Cohort 5: Participants receiving Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Part 2: Cohort 7: Participants receiving Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Part 1: Cohort 3: Participants receiving Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Part 1: Cohort 1: Participants receiving Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Part 2: Cohort 8: Participants receiving PlaceboPlaceboComparator Group · 2 Interventions: Placebo, Midazolam · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1920

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (day 1) and up to 6.5 weeks

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
335 Previous Clinical Trials
462,099 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,567 Previous Clinical Trials
6,134,192 Total Patients Enrolled

Eligibility Criteria

Age 18 - 50 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Pennsylvania100.0%
What site did they apply to?
GSK Investigational Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Is the age requirement for this study inclusive of individuals aged 50 and above?

"This medical trial is seeking patients aged 18 to 50 years old." - Anonymous Online Contributor

Unverified Answer

What potential risks are associated with taking VH4524184 DL1 for individuals?

"The safety of Part 1: Cohort 1: Participants receiving VH4524184 DL1 is assumed to be low, and scored a one due to the limited clinical data present during Phase 1 trials suggesting efficacy or safety." - Anonymous Online Contributor

Unverified Answer

How many participants have enrolled in this experiment?

"Affirmative. Data hosted on clinicaltrials.gov states that this medical study, which was initially posted on December 2nd 2022, is presently searching for participants. 105 patients must be recruited from one single location to fulfill the requirements of the trial." - Anonymous Online Contributor

Unverified Answer

Does this experiment have any open slots for volunteers?

"Affirmative. Per the clinicaltrials.gov listing, this trial is open for recruitment of 105 patients from a single medical centre. It was initially posted on December 2nd 2022 and last updated on January 11th 2023." - Anonymous Online Contributor

Unverified Answer

For whom is this clinical research available?

"This scientific inquiry is in search of 105 individuals that are living with Human Immunodeficiency Virus (HIV) and aged between 18 to 50. For prospective candidates to be considered, they must meet the following criteria: chronological age from 18-50 years old, healthily functioning bodies that weight at least 110 lbs for males or 99 lbs for females along with a Body Mass Index within a range of 18.5 - 32 kg/m^2 respectively; male participants have no contraceptive restrictions while female applicants need to not be expecting, lactating nor physically capable of bearing children." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.