RecruitingPhase 1

First Time in Human Study of Long Acting VH4524184 Formulations

United States372 participantsStarted 2024-03-21

Plain-language summary

The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
. Participants who are negative for SARS-CoV-2, performed on admission/readmission to the Phase 1 unit, using an approved molecular test (PCR).
. Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
. Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg/m\^2 (inclusive) for all cohorts except B19. For Cohort B19, body mass index within the range \>32.0 to 37.0 kg/m\^2 (inclusive).
. Male or female
. Male Participants: No restrictions for male participants
. Participants of female sex assigned at birth:

Exclusion criteria

. History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of participants reporting adverse events (AEs) and related AEs

Timeframe: From first study dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

Percentage of participants with AEs by severity

Timeframe: From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

Percentage of participants discontinuing the treatment due to AEs

Timeframe: From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

Change from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase parameters

Timeframe: From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

Change from baseline in total bilirubin parameters

Timeframe: From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

Change from baseline in international normalized ratio (INR) parameters

Trial details

NCT IDNCT06310551

SponsorViiV Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-01-21

Contact for this trial

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

View on ClinicalTrials.gov More HIV Infections trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
. Participants who are negative for SARS-CoV-2, performed on admission/readmission to the Phase 1 unit, using an approved molecular test (PCR).
. Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
. Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg/m\^2 (inclusive) for all cohorts except B19. For Cohort B19, body mass index within the range \>32.0 to 37.0 kg/m\^2 (inclusive).
. Male or female
. Male Participants: No restrictions for male participants
. Participants of female sex assigned at birth:

Exclusion criteria

. History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.

What they're measuring

Percentage of participants reporting adverse events (AEs) and related AEs

Timeframe: From first study dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

Percentage of participants with AEs by severity

Timeframe: From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

Percentage of participants discontinuing the treatment due to AEs

Timeframe: From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

Change from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase parameters

Timeframe: From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

Change from baseline in total bilirubin parameters

Timeframe: From first dose administration (Day 1) up to Week 52 post last dose, and Week 80 post last dose for a sub-group of participants

Change from baseline in international normalized ratio (INR) parameters