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)

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose administration of vh4524184 (day 1) up to study end (week 52 post last dose)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Percentage of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities

Trial Design

6Treatment groups

Experimental Treatment

Group I: Multiple doses GroupExperimental Treatment12 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 B IM GroupExperimental Treatment3 Interventions

Participants receive a Formulation B starting dose of VH4524184 LAI intramuscularly (IM).

Group V: Formulation A SC GroupExperimental Treatment4 Interventions

Participants receive a Formulation A starting dose of VH4524184 LAI subcutaneously (SC).

Group VI: 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