186 Participants NeededMy employer runs this trial

VH4524184 for HIV Infection

Recruiting at 97 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: ViiV Healthcare
Must be taking: Emtricitabine, Tenofovir alafenamide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, VH4524184 (an experimental treatment), for individuals with HIV-1 who have never received treatment for their infection. The study compares two different doses of VH4524184, administered with emtricitabine and tenofovir alafenamide, against a standard HIV treatment. The researchers aim to understand VH4524184's long-term effectiveness and determine the best dose for future studies. This trial suits individuals with documented HIV-1 infection who have not yet received treatment. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in HIV treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you must stop taking your current medications, but it mentions that participants receiving any protocol-prohibited medication who are unwilling or unable to switch to an alternate medication are excluded. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that VH4524184 was safe and well-tolerated in earlier studies. Participants in these studies reported no major safety issues. One study highlighted VH4524184 as a new type of medication for HIV-1 that could work longer with fewer doses. While all medications can have side effects, the early results for VH4524184 are promising for those new to HIV treatment. Prospective trial participants should discuss the possible risks and benefits with their healthcare provider.12345

Why are researchers excited about this trial's treatment for HIV?

Researchers are excited about VH4524184 because it offers a fresh approach to treating HIV infection. Unlike current standard treatments that mainly focus on inhibiting viral replication, VH4524184 might work through a different mechanism or target, potentially enhancing its effectiveness. The trial is exploring various doses of VH4524184 in combination with FTC/TAF, which are well-known components of HIV therapy, to optimize its impact. This could lead to a more potent or better-tolerated treatment option for those living with HIV.

What evidence suggests that this trial's treatments could be effective for HIV?

Research has shown that VH4524184 may help treat HIV-1. Early results found that VH4524184 significantly reduced the amount of HIV in the blood. This new drug prevents the virus from multiplying. In this trial, participants will receive varying doses of VH4524184 combined with FTC/TAF, or a selected dose of VH4524184 with FTC/TAF, to evaluate its effectiveness. Studies have demonstrated its efficacy at different doses, suggesting it could effectively manage HIV-1. These findings support further research and testing of VH4524184 for treating HIV.12467

Are You a Good Fit for This Trial?

This trial is for adults (18+) with HIV-1 who have never received HIV treatment, have a viral load of at least 1000 copies/mL, a CD4 count over 200, and meet certain weight and BMI requirements. Women must use effective birth control or not be able to get pregnant. Participants must test negative for pregnancy before starting.

Inclusion Criteria

I can sign and understand the consent form.
I am HIV positive with a recent test showing over 1000 copies/mL.
I am 18 years old or older.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral doses of VH4524184 with FTC/TAF or DTG/3TC

24 months
Monthly visits for monitoring and medication dispensing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • VH4524184

Trial Overview

The study compares two doses of a new oral drug called VH4524184 (each combined with emtricitabine and tenofovir alafenamide) against the standard HIV treatment dolutegravir/lamivudine in people who haven't had prior HIV therapy.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: VH4524184 selected dose + FTC / TAFExperimental Treatment2 Interventions
Group II: VH4524184 Dose B + FTC / TAFExperimental Treatment2 Interventions
Group III: VH4524184 Dose A+ FTC / TAFExperimental Treatment2 Interventions
Group IV: DTG + 3TCActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ViiV Healthcare

Lead Sponsor

Trials
379
Recruited
479,000+
Founded
2009
Headquarters
London, England, UK
Known For
HIV Research
Top Products
- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)
Dr. Harmony Garges profile image

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse profile image

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

Citations

Phase 1 Evaluation of VH4524184, a Third-Generation ... - PMC

VH4524184 (VH-184) is a third-generation INSTI with long-acting potential in development for HIV-1 treatment. The in vitro antiviral potency of VH-184 is ...

VH4524184 Proof-of-Concept in Treatment-Naïve Adults ...

The purpose of this study is to evaluate the safety, tolerability, ability of VH4524184 when given alone to reduce the amount of HIV (viral load) in people ...

ViiV Healthcare premieres early data showing antiviral ...

An investigational integrase strand transfer inhibitor (INSTI), VH4524184 (VH184), retained its antiviral activity and could be effective in countering second- ...

Phase 1 Evaluation of VH4524184, a Third-Generation ...

These data support the safety and further development of VH-184 as a third-generation INSTI with long-acting potential for HIV-1 treatment.

First data on third-generation integrase inhibitor from ViiV

Results from a phase 1 placebo-controlled study of single and multiple doses of the investigational integrase inhibitor VH4524184 (VH-184) in 84 HIV negative ...

First Time in Human Study of Long Acting VH4524184 ...

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 ...

Phase 1 Study of VH4524184 (VH-184), a New Third- ...

HIV-1 treatment. • VH-184 demonstrated a good safety and tolerability profile in this FTIH study. • FTIH study results helped characterize VH ...