What is VH4524184 studying for HIV-1 infection?

VH4524184 is being studied to see how well it works in adults with HIV-1 who have never had treatment before. The study compares two doses of VH4524184 combined with other HIV medications to a standard HIV treatment. This research, led by ViiV Healthcare, aims to understand the long-term effects and best dosing of VH4524184.

Who may be eligible for this HIV-1 clinical trial?

Adults aged 18 years or older with documented HIV-1 infection who have never received HIV treatment may be eligible. Both males and females can participate if they meet weight and health criteria and females are not pregnant or breastfeeding. Please review eligibility criteria for more details.

Is there any cost to participate in this HIV-1 clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07202546

A Phase 2b Randomized, Open-Label Study Evaluating Oral VH4524184 With Emtricitabine and Tenofovir Alafenamide in Adults with HIV-1 Who Have Not Received Treatment

Led by ViiV Healthcare · Updated on 2026-05-08

150

Participants Needed

113

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the medication VH4524184 for treating adults with HIV-1 who have never received treatment before. The study compares two doses of VH4524184, each combined with emtricitabine and tenofovir alafenamide FTCTAF, against a standard treatment of dolutegravir and lamivudine DTG3TC. This phase 2b trial aims to provide data on the long-term antiviral effects and appropriate dosing of VH4524184 for future studies. Participants are randomly assigned to receive either a low or high daily dose of VH4524184 combined with FTCTAF for 12 months, or the standard DTG3TC treatment daily for 24 months. Those on VH4524184 may continue with a selected dose plus FTCTAF from 12 to 24 months. All medications are taken orally, and the study is open-label, meaning participants and researchers know which treatment is given. During the study, participants will undergo regular assessments including blood tests to measure HIV-1 RNA levels and CD4 T-cell counts, monitoring for side effects, and measuring drug concentrations in the blood. The primary outcome is the percentage of participants achieving HIV-1 RNA suppression below 50 copiesmL at 12 months. Safety and maintenance of viral suppression will also be tracked through month 24. The total participation can last up to two years, with ongoing evaluations to understand long-term treatment effects.

CONDITIONS

Brief Title

A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

At least 18 years of age at time of informed consent
Screening CD4+ T-cell count greater than 200 cells/microlitre
Documented HIV-1 infection with plasma HIV-1 RNA of at least 1000 copies/millilitre
No prior antiretroviral treatment after HIV-1 diagnosis
Body weight at least 50 kg for males assigned at birth, or at least 45 kg for females assigned at birth
Body mass index (BMI) between 18.5 and 35.5 kg/m2 inclusive
For females assigned at birth: not pregnant or breastfeeding, and either non-childbearing potential or using effective contraception with failure rate under 1%
Ability to give signed informed consent

You will not qualify if you...

Breastfeeding or planning to breastfeed during the study
Acute HIV infection with recent symptoms or documented viremia without antibody production within 3 months
Active CDC Stage 3 disease except cutaneous Kaposi's sarcoma not requiring systemic therapy
Unstable liver disease or biliary abnormalities except Gilbert's syndrome or stable chronic liver disease
History of cirrhosis with or without viral hepatitis co-infection
Hepatitis C virus (HCV) co-infection
HIV and hepatitis B virus (HBV) co-infection
Uncontrolled malignancy; controlled malignancy may be included with agreement
Any condition interfering with study compliance or safety as judged by investigator
Conditions affecting absorption, metabolism, or ability to take oral medication
Significant cardiovascular disease or history of cardiac events
Use of protocol-prohibited medications without willingness to switch
Sensitivity or allergy to study medications or components
Need for chronic anticoagulation except low-dose aspirin or hereditary coagulation disorders
Recent treatment with radiation, chemotherapy, immunosuppressants, or anti-HIV agents within specified timeframes
Participation in another clinical study within 30 days prior to consent
Known or suspected resistance mutations to integrase inhibitors or nucleoside reverse transcriptase inhibitors
Creatinine clearance below 60 mL/min/1.73 m2
Alanine transaminase (ALT) levels greater than three times the upper limit of normal
Grade 4 laboratory abnormalities except specific exceptions
Screening ECG showing prolonged QT interval beyond specified limits

Research Team

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center

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