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Part 1: Cohort 2: Participants receiving VH4524184 DL2 for Human Immunodeficiency Virus Infection

Phase 1
Recruiting
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 6.5 weeks
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and up to 6.5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and up to 6.5 weeks 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: 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: Change from Baseline in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline phosphatase (ALP) (International units per liter)
+29 more
Secondary outcome measures
Part 1: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Part 2: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities
Part 3: Number of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities

Trial Design

19Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 3: Cohort 10: VH4524184 Fasted/ VH4524184 FedExperimental Treatment1 Intervention
Eligible participants will receive VH4524184 under fasted condition in Treatment Period 1 followed by VH4524184 under fed condition in Treatment Period 2 during Cohort 10 (Part 3) of the study. Treatment Periods will be separated by a washout period.
Group II: Part 2: Cohort 9: Participants receiving VH4524184 RL3Experimental Treatment2 Interventions
Eligible participants will receive VH4524184 RL3 during Cohort 9 (Part 2) (optional) of the study. If Cohort 9 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of VH4524184.
Group III: Part 2: Cohort 8: Participants receiving VH4524184 RL2Experimental Treatment2 Interventions
Eligible participants will receive VH4524184 RL2 during Cohort 8 (Part 2) of the study. If Cohort 8 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of VH4524184
Group IV: Part 2: Cohort 7: Participants receiving VH4524184 RL1Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 Repeat dose Level 1 (RL1) during Cohort 7 (Part 2) of the study.
Group V: Part 1: Cohort 6: Participants receiving VH4524184 DL6Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study.
Group VI: Part 1: Cohort 5: Participants receiving VH4524184 DL5Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study.
Group VII: Part 1: Cohort 4: Participants receiving VH4524184 DL4Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 DL4 during Cohort 4 of Part 1 of the study.
Group VIII: Part 1: Cohort 3: Participants receiving VH4524184 DL3Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 DL3 during Cohort 3 of Part 1 of the study.
Group IX: Part 1: Cohort 2: Participants receiving VH4524184 DL2Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 DL2 during Cohort 2 of Part 1 of the study.
Group X: Part 1: Cohort 1: Participants receiving VH4524184 DL1Experimental Treatment1 Intervention
Eligible participants will receive VH4524184 Dose Level 1 (DL1) during Cohort 1 of Part 1 of the study.
Group XI: Part 1: Cohort 5: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 DL5 during Cohort 5 (optional) of Part 1 of the study.
Group XII: Part 1: Cohort 6: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 DL6 during Cohort 6 (optional) of Part 1 of the study.
Group XIII: Part 1: Cohort 1: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 DL1 during Cohort 1 of Part 1 of the study.
Group XIV: Part 2: Cohort 9: Participants receiving PlaceboPlacebo Group2 Interventions
Eligible participants will receive Placebo matching VH4524184 RL3 during Cohort 9 (Part 2) (optional) of the study. If Cohort 9 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of Placebo matching VH4524184.
Group XV: Part 2: Cohort 7: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 RL1 during Cohort 7 (Part 2) of the study.
Group XVI: Part 1: Cohort 2: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 DL2 during Cohort 2 of Part 1 of the study.
Group XVII: Part 1: Cohort 4: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 DL4 during Cohort 4 of Part 1 of the study.
Group XVIII: Part 2: Cohort 8: Participants receiving PlaceboPlacebo Group2 Interventions
Eligible participants will receive Placebo matching VH4524184 RL2 during Cohort 8 (Part 2) of the study. If Cohort 8 is the highest Part 2 dose cohort, participants may also receive midazolam probe before and following repeat dose administration of Placebo matching VH4524184.
Group XIX: Part 1: Cohort 3: Participants receiving PlaceboPlacebo Group1 Intervention
Eligible participants will receive Placebo matching VH4524184 DL3 during Cohort 3 of Part 1 of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1910

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
359 Previous Clinical Trials
468,438 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,595 Previous Clinical Trials
6,143,825 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 age requirement for this study inclusive of individuals aged 50 and above?

"This medical trial is seeking patients aged 18 to 50 years old."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity
2022. "A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05631704.
~45 spots leftby Apr 2025
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