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Virus Therapy

Long-Acting VH4524184 for HIV

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 from first dose administration of vh4524184 (day 1) up to study end (week 52 post last dose)
Awards & highlights

Summary

This trial aims to find safe doses of VH4524184 that can be given through injection and have the right level of drug in the body to create a long-lasting treatment for HIV-1.

Who is the study for?
This trial is for individuals with HIV infection. It's a first-time study of VH4524184, which aims to find safe doses that can be given less often than current treatments. Specific eligibility details are not provided.
What is being tested?
The trial tests various formulations and delivery methods (like injections into muscle or under the skin) of VH4524184, including placebos and an oral version, to see which works best as a long-acting antiretroviral therapy.
What are the potential side effects?
Since this is a first-in-human study, specific side effects aren't listed but may include reactions at the injection site, general discomfort, or other unexpected responses due to the newness of the treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose administration of vh4524184 (day 1) up to study end (week 52 post last dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose administration of vh4524184 (day 1) up to study end (week 52 post last dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase parameters
Change from baseline in international normalized ratio (INR) parameters
Change from baseline in total bilirubin parameters
+3 more
Secondary outcome measures
Percentage of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities

Trial Design

5Treatment groups
Experimental Treatment
Group I: Multiple doses GroupExperimental Treatment10 Interventions
VH4524184 LAI formulations administered SC or IM as single doses that achieve adequate PK exposure targets, may be evaluated for safety and tolerability as multiple doses.
Group II: Formulation C SC GroupExperimental Treatment4 Interventions
Participants receive a Formulation C starting dose of VH4524184 LAI subcutaneously. This intervention is optional and initiated only if Formulation B is poorly tolerated.
Group III: Formulation B SC GroupExperimental Treatment4 Interventions
Participants receive a Formulation B starting dose of VH4524184 LAI subcutaneously.
Group IV: Formulation A SC GroupExperimental Treatment4 Interventions
Participants receive a Formulation A starting dose of VH4524184 LAI subcutaneously (SC).
Group V: Formulation A IM GroupExperimental Treatment3 Interventions
Participants receive a Formulation A starting dose of VH4524184 LAI intramuscularly (IM).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rHuPH20
2008
Completed Phase 2
~650

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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
369 Previous Clinical Trials
469,510 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,788 Previous Clinical Trials
8,176,735 Total Patients Enrolled
~48 spots leftby Mar 2027
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