Drug Database: VH4524184

What is VH4524184? What is VH4524184?

What is VH4524184?

VH4524184 is an investigational drug that is being studied to treat HIV.¹

VH4524184 belongs to a group of HIV drugs called integrase inhibitors.¹ Integrase inhibitors block an HIV enzyme called integrase. By blocking integrase, integrase inhibitors prevent HIV from multiplying and can reduce the amount of HIV in the body.

VH4524184 may be effective against certain HIV strains that are resistant to other HIV drugs.^3,4

To learn about how investigational drugs are tested during clinical trials, read the HIVinfo What is an Investigational HIV Drug? and HIV/AIDS Clinical Trials fact sheets.

Select clinical trials of VH4524184 Select clinical trials of VH4524184

Select clinical trials of VH4524184

Study Name: NCT06214052

Phase: 2a
Status: This study has been completed.
Locations: Multiple countries, including United States
Purpose: The purpose of this study was to evaluate oral VH4524184 given by itself (monotherapy) in adults with HIV who have never received HIV medicines before. Researchers looked at 1) how the body handles VH4524184, 2) whether VH4524184 is safe and easy to tolerate, and 3) how well VH4524184 works to reduce viral load in the body.⁵
Selected Study Results: Results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2025 and showed that VH4524184 worked as well as dolutegravir (brand name: Tivicay) in reducing viral load levels in the body.⁴

Study Names: INNOVATE; NCT07202546

Phase: 2b
Status: This study is currently recruiting participants.
Locations: Multiple countries, including United States
Purpose: The purpose of this study is to see whether oral VH4524184, given with emtricitabine/tenofovir alafenamide (brand name: Descovy), is safe and works to control viral load levels in adults who have never received HIV medicines before.²

For more details on the studies listed above, see the Health Professional version of this drug summary.

Additional studies evaluating VH4524184 for HIV treatment have been completed or are being conducted, including the following Phase 1 trials:

• NCT05631704 was a study that looked at whether oral VH4524184 is safe and tolerable in adults without HIV. Researchers also looked at how the body handles VH4524184 and whether VH4524184 might interact with other drugs. This study has been completed, and results are available from Clin Infect Dis (2025).^6,7
• NCT06310551 is a study looking at how the body handles long-acting injectable forms of VH4524184 and whether these forms of VH4524184 are safe and tolerable in adults without HIV. Results thus far were presented at CROI 2026. This study is currently recruiting participants.⁸

What side effects might VH4524184 cause? What side effects might VH4524184 cause?

What side effects might VH4524184 cause?

One goal of HIV research is to identify safe new drugs that have fewer side effects. In the NCT06214052 study discussed in the previous section, side effects related to VH4524184 were reported in five participants and included diarrhea, dizziness, fatigue, increased levels of pancreatic enzymes (amylase and lipase), nausea, and vomiting. All VH4524184-related side effects were mild, and each occurred in one participant. There were no serious side effects or side effects resulting in study discontinuation.^4,5

Because VH4524184 is still being studied, information on possible side effects of the drug is not complete. As testing of VH4524184 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying VH4524184? Where can I get more information about clinical trials studying VH4524184?

Where can I get more information about clinical trials studying VH4524184?

More information about VH4524184-related research studies is available from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)

Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Research Trials and You.

References References

References

1. ViiV Healthcare website. HIV medicines in development. Accessed May 15, 2026
2. ViiV Healthcare. A Phase 2b randomized, open-label active controlled study evaluating the safety and efficacy of oral VH4524184 coadministered with emtricitabine and tenofovir alafenamide in treatment naive viremic persons with HIV-1 (INNOVATE study). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on September 30, 2025. NLM Identifier: NCT07202546. Accessed May 15, 2026
3. Seki T, Arita S, Ishida K, et al. In vitro characterization of VH4524184 (VH-184, S-365598), a new third-generation integrase strand transfer inhibitor (INSTI) with a unique resistance profile. International AIDS Conference; July 22-26, 2024; Munich, Germany. Conference reports for National AIDS Treatment Advocacy Project (NATAP); 2024. Accessed May 15, 2026
4. Rogg L, Núñez SA, Mingrone MV, et al. Proof-of-concept Phase 2a trial of VH4524184 (VH-184), a third-generation integrase strand transfer inhibitor. Conference on Retroviruses and Opportunistic Infections (CROI); March 9-12, 2025; San Francisco, CA. Conference reports for National AIDS Treatment Advocacy Project (NATAP); 2025. Accessed May 15, 2026
5. ViiV Healthcare. A Phase 2a, randomized, double-blind (sponsor unblinded), placebo-controlled, study to investigate the antiviral effect, safety, tolerability and pharmacokinetics of VH4524184 in HIV-1 infected treatment naïve adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on January 9, 2024. NLM Identifier: NCT06214052. Accessed May 15, 2026
6. ViiV Healthcare. A Phase 1 double-blind (sponsor-unblinded), placebo-controlled randomized, single and multiple ascending dose first-time-in-human study to investigate the safety, tolerability, and pharmacokinetics of VH4524184 and the potential for changes in cytochrome P450 3A (CYP3A) activity. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on November 18, 2022. NLM Identifier: NCT05631704. Accessed May 15, 2026
7. Rogg L, Underwood M, Hanan N, et al. Phase 1 evaluation of VH4524184, a third-generation integrase strand transfer inhibitor with an enhanced resistance profile. Clin Infect Dis. 2025;81(3):510-520. doi:10.1093/cid/ciaf135. Accessed May 15, 2026
8. ViiV Healthcare. A Phase 1 double-blind (sponsor-unblinded), placebo-controlled randomized, single ascending dose and multiple dose study to investigate the safety, tolerability, and pharmacokinetics of parenterally administered VH4524184 in healthy adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on March 5, 2024. NLM Identifier: NCT06310551. Accessed May 15, 2026