A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV

Running, not enrolling · Phase 1

Conditions studied: HIV Infections

In brief

This study investigates the use of VH3810109 with or without FTR to reduce the size and activity of the HIV viral reservoir in two sub-populations of people living with HIV: treatment-naïve adults (Population 1) and treatment-experienced adults currently taking a standard of care (SOC) integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) regimen (Population 2). The study is designed to include the following phases: Randomized Intervention Phase (Step 1), Analytical Treatment Interruption (ATI) Phase (Step 2), and Follow-up Phase (Step 3).

Key facts

Study ID

NCT07053384

Run by

ViiV Healthcare

People needed

130

Starts

2025-07-10

Expected to finish

2028-09-06

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• AGE
• Age between 18 years and 70 years old at the time of obtaining informed consent.
• SEX AND GENDER • Persons of any sex or gender are eligible. Note: Participants of childbearing potential (POCBP) are eligible to participate if not pregnant, not lactating, and agreeing to adhere to study requirements for use of contraception and pregnancy avoidance.
• PARTICIPANT KEY CHARACTERISTICS • Participant has a documented diagnosis of HIV-1 infection. Note: Participants in Population 1 must have a documented positive HIV antibody result available for Screening.
• Population 1 only:
• Plasma HIV-1 RNA >=2000 copies/milliliter (c/mL) at Screening.
• CD4+ T cell count >=300 cells/microliter (μL) at Screening.
• Antiretroviral treatment naïve, defined as no exposure to ART after a diagnosis of HIV-1 infection, prior to enrollment.
• Population 2 only:
• Participant is stably virologically suppressed (plasma HIV-1 RNA <50 c/mL).
• Documented evidence of uninterrupted treatment with oral non-boosted INSTI-based ART for at least 6 months prior to Screening, as well as uninterrupted treatment with ART (any guideline-recommended oral regimen) for at least 24 months prior to Screening.
• CD4+ T cell count >=450 cells/μL at Screening.
• WEIGHT
• Body weight >=50 kg to <=115 kg.
• INFORMED CONSENT • Participant is capable of giving written informed consent, which includes adherence to the requirements and restrictions listed in the consent form and in the protocol.

You may not qualify if…

• CONCURRENT MEDICAL CONDITIONS \& MEDICAL HISTORY
• Participant is pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
• Participant has documented diagnosis of HIV-2 infection.
• Participant is known to have acquired HIV via perinatal transmission.
• Any evidence of a current or known past Center for Disease Control and Prevention (CDC) Stage 3 disease.
• Any ongoing malignancy or history of systemic cancers, such as Kaposi's sarcoma and lymphoma, or other virus-associated malignancies.
• Ongoing or clinically relevant pancreatitis.
• Current HIV-related kidney disease.
• History of or active HIV-associated dementia or progressive multifocal leukoencephalopathy.
• CARDIAC \& CARDIOVASCULAR CONDITIONS
• Participants who are at clinically significant risk of cardiovascular disease.
• Ongoing or any lifetime history of clinically significant cardiovascular or cardiac disease.
• Confirmed QTcF value outside normal range at Screening or Day 1.
• HEPATIC CONDITIONS
• History of clinically relevant hepatitis in the 6 months prior to Screening.
• Participants with severe hepatic impairment.
• Advanced MAFLD and advanced non-alcoholic steatohepatitis, if evidence for substantial fibrosis (fibrosis score ≥F2) or evidence of cirrhosis.
• Unstable liver disease.
• History of liver cirrhosis with or without hepatitis viral co-infection.
• NEUROPSYCHIATRIC CONDITIONS • Participants who pose a significant suicide risk.
• LABORATORY DIAGNOSTIC ASSESSMENTS
• Participants who are experiencing (Population 1) or are known to have initiated ART during (Population 2) acute HIV infection.
• Any verified Grade 4 laboratory abnormality at Screening, excluding asymptomatic elevations of lipids or CPK.
• Alanine transferase (ALT) >=3 times the upper limit of normal (ULN) at Screening.
• Estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m\^2.

Where it is running

• GSK Investigational Site — Bakersfield, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Ft. Pierce, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Brussels, Belgium
• GSK Investigational Site — Ghent, Belgium
• GSK Investigational Site — Aarhus, Denmark
• GSK Investigational Site — Hvidovre, Denmark
• GSK Investigational Site — Rotterdam, Netherlands
• GSK Investigational Site — Barcelona, Spain
• GSK Investigational Site — Barcelona, Spain
• GSK Investigational Site — Barcelona, Spain
• GSK Investigational Site — Barcelona, Spain
• GSK Investigational Site — Barcelona, Spain
• GSK Investigational Site — Barcelona, Spain
• GSK Investigational Site — Córdoba, Spain

Full record on ClinicalTrials.gov

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