VH4524184 for HIV Infection

Recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: ViiV Healthcare

Must not be taking: Cytochrome P450 modulators

Disqualifiers: Diabetes, Hypertension, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the new drug VH4524184, a potential treatment for HIV, behaves in healthy adults. Researchers aim to understand how the body absorbs it and how it interacts with other medicines. Participants will receive different doses of VH4524184, sometimes with food, and in combination with other drugs like Itraconazole or Rifabutin. The trial seeks generally healthy adults who do not have conditions affecting drug processing or who are not taking medications that might interfere. It offers a valuable opportunity for those who meet the criteria and wish to contribute to HIV treatment research. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications or supplements that affect cytochrome P450 enzymes 7 to 14 days before starting the study. If you're on such medications, you may need to stop them before participating.

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

Research has shown that VH4524184, a new treatment being tested for HIV, has been safe and well-tolerated in earlier studies. During initial testing, participants generally did not experience serious side effects. The studies also found that the treatment does not significantly affect CYP3A4, a common liver enzyme that processes many drugs. This is a positive sign for its safety when used with other medications. These findings support further testing and development of VH4524184 as a potential long-acting treatment for HIV. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about VH4524184 for HIV infection because it represents a new approach in treatment. Unlike traditional antiretroviral therapies that primarily focus on inhibiting viral replication, VH4524184 is being explored for its potential to enhance the body's immune response to the virus. This could offer a complementary strategy to existing treatments, possibly improving outcomes for patients who do not respond as well to current therapies. Additionally, some trial arms are investigating how VH4524184 interacts with other medications like Itraconazole, Rifabutin, and Phenytoin, which could broaden its application and effectiveness in managing HIV alongside other conditions.

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

Research has shown that VH4524184, a new drug being tested for HIV, has produced promising results in early studies. This medication helps prevent the virus from integrating with human DNA. Early data indicated that VH4524184 significantly reduced the amount of HIV in the blood, suggesting high effectiveness against the virus. The drug is also noted for its safety and general tolerability among patients. This trial will explore various treatment arms, including different dosing sequences and combinations with other medications, to further evaluate VH4524184 as a potential long-lasting treatment for HIV. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 60 who have normal liver function tests. Men of any reproductive potential can join, while women must not be pregnant or breastfeeding and should be unable to bear children. Participants must understand the study and agree to its terms.

Inclusion Criteria

I am either male or female.

3\. Participants who are overtly healthy as determined by medical evaluation 4. AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) 6. Capable of giving signed informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VH4524184 tablets under various conditions to evaluate absorption, food effects, and drug-drug interactions

6 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VH4524184

Trial Overview

The study is testing VH4524184 tablets in healthy adults to see how they're absorbed, their effects when taken with food, and how they interact with other drugs like Rifabutin, Itraconazole, Phenytoin, and Metformin.

How Is the Trial Designed?

Group I: Part 2_Cohort 2B Experimental Treatment 2 Interventions

Participants will receive VH4524184 tablet and Phenytoin.

Group II: Part 2_Cohort 2A Experimental Treatment 2 Interventions

Participants will receive VH4524184 and Rifabutin.

Group III: Part 2_Cohort 1 Experimental Treatment 2 Interventions

Participants will receive VH4524184 tablet and Itraconazole.

Group IV: Part 2_ Cohort 3 Experimental Treatment 3 Interventions

Participants will receive Metformin, Digoxin and VH4524184 tablets.

Group V: Part 1B_VH4524184 Sequence 6) Experimental Treatment 1 Intervention

Participants will receive VH4524184 tablet of Dose level 2 following a high fat meal and then in fasted condition.

Group VI: Part 1B_VH4524184 (Sequence 8) Experimental Treatment 1 Intervention

Participants will receive VH4524184 tablet of Dose level 3 following a high fat meal and then in a fasted condition.

Group VII: Part 1B_VH4524184 (Sequence 7) Experimental Treatment 1 Intervention

Participants will receive VH4524184 tablet of Dose level 3 in fasted condition and then followed by intake of a high fat meal.

Group VIII: Part 1B_VH4524184 (Sequence 5) Experimental Treatment 1 Intervention

Participants will receive VH4524184 tablet of Dose level 2 in fasted condition and then followed by intake of a high fat meal.

Group IX: Part 1A_VH4524184 (Sequence 4) Experimental Treatment 1 Intervention

Participants will receive VH4524184 tablet(s) of Dose level 2 followed by Dose level 3 in fasted condition.

Group X: Part 1A_VH4524184 (Sequence 3) Experimental Treatment 1 Intervention

Participants will receive VH4524184 tablet(s) of Dose level 3 followed by Dose level 2 in fasted condition.

Group XI: Part 1A_VH4524184 (Sequence 2) Experimental Treatment 1 Intervention

Participants will receive VH4524184 tablet(s) of Dose level 2 followed by Dose level 1 in fasted condition.

Group XII: Part 1A_VH4524184 (Sequence 1) Experimental Treatment 1 Intervention

Participants will receive VH4524184 tablet(s) of Dose level 1 followed by Dose level 2 in fasted condition.

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

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

Citations

1.

academic.oup.com

academic.oup.com/cid/article/81/3/510/8090171

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

VH4524184 does not inhibit/induce CYP3A4, has a moderate food effect, and demonstrated a good safety and tolerability profile in this first-time-in-human s.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07202546

A Phase 2b Study Evaluating Oral VH4524184 Regimens ...

The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing ...

3.

viivhealthcare.com

viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/july/viiv-healthcare-premieres-early-data-showing-antiviral-activity/

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- ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40117383/

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 ...

5.

aidsmap.com

aidsmap.com/news/mar-2025/new-long-acting-hiv-drugs-show-promising-early-results

New long-acting HIV drugs show promising early results

Results showed that VH-184 led to a rapid and potent decline in HIV-1 RNA levels. The mean maximum reduction in viral load was -1.17 log10 ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06214052

Study Details | NCT06214052 | VH4524184 Proof-of- ...

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 ...

7.

viivexchange.com

viivexchange.com/content/dam/cf-viiv/viivexchange/medical/pdf/aids-2024-rogg-vh-184-oral-ftih-oab2603-disc.pdf

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 ...