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Can a new drug combo flush out hidden HIV?

NCT ID NCT07053384

Disease control Sponsor: ViiV Healthcare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This early-stage study tests whether adding an experimental drug (VH3810109) with or without another drug (fostemsavir) to standard HIV therapy can reduce the hidden viral reservoir in people living with HIV. About 107 adults, either new to treatment or already on stable therapy, will participate. The goal is to see if these combinations can lower the amount of inactive HIV hiding in cells, which is a key step toward better long-term control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. Exclusion Criteria: 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. * Hemoglobin \>=Grade 2 at Screening. * Platelets \>=Grade 2 at Screening. * Absolute Neutrophil Count (ANC) ≥Grade 2 at Screening. * Any acute abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's inclusion in an interventional clinical study. Population 2 only: • Two or more plasma HIV-1 RNA results \>=50 c/mL in the 18 months prior to Screening. INFECTIOUS DISEASES * Active hepatitis B virus (HBV) co-infection. * Active hepatitis C virus (HCV) co-infection. * Participant has untreated syphilis before enrolment. * Known history of active Mycobacterium TB disease (regardless of treatment status). ANTIRETROVIRAL RESISTANCE • Known major resistance-associated mutations to second-generation INSTIs or to antiretroviral (ARV) agents from 2 or more drug classes. PRIOR AND CONCOMITANT MEDICATIONS * Prior use of any of the following agents: \- long-acting ARVs (any dose in the past 24 months or within 5 half-lives \[whichever is longer\]) \- FTR (any lifetime use) \- HIV-1 immunotherapeutic vaccines or prophylactic vaccines (any lifetime use) \- HIV-1 monoclonal antibody therapy (any lifetime use). * Prior receipt of any approved or experimental non-HIV vaccination within 2 weeks prior to study enrolment. * History of systemic corticosteroids, immunosuppressive anti-cancer, interleukins, systemic interferons, or systemic chemotherapy, within 6 months prior to Screening. * Participant has received an experimental drug or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent (whichever is longer), prior to enrolment. * Treatment with any of the following agents within 30 days of enrolment: \- radiation therapy * cytotoxic chemotherapeutic agents * anti-tuberculosis therapy * immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. * Participant is receiving any protocol-defined prohibited medication and is unwilling or unable to switch to an alternate medication. Prohibited medications must be stopped within 7 days (or 14 days if the drug is a potential CYP3A4 enzyme inducer) or 5 half-lives (whichever is longer), prior to enrolment. Population 1 only: • Known use of PrEP or PEP within \<30 days (for oral agents) or \<52 weeks (for LA parenteral agents) of HIV-1 diagnosis. Participants with a documented seronegative result \>=30 days after the last dose of oral PrEP or PEP (or \>=52 weeks after the last dose of LA PrEP) are not excluded. Population 2 only: • Current use of NNRTI-containing ART. OTHER EXCLUSIONS * History or presence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy that contraindicates study participation. * Any condition which may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study drugs. * Any pre-existing physical or mental condition (including substance use disorder) which, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. * Participant is currently participating in, or anticipates being selected for, any other interventional study. * Participant is known or suspected to be an HIV long-term non-progressor or elite controller, based on historical off-treatment plasma HIV-1 RNA results.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections

Contacts and locations

Locations

  • GSK Investigational Site

    Bakersfield, California, 93301, United States

  • GSK Investigational Site

    San Diego, California, 92103, United States

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982, United States

  • GSK Investigational Site

    Orlando, Florida, 32803, United States

  • GSK Investigational Site

    Chicago, Illinois, 60611, United States

  • GSK Investigational Site

    Kansas City, Missouri, 64111, United States

  • GSK Investigational Site

    St Louis, Missouri, 63110, United States

  • GSK Investigational Site

    New York, New York, 10032, United States

  • GSK Investigational Site

    Cincinnati, Ohio, 45267, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213, United States

  • GSK Investigational Site

    Dallas, Texas, 75208, United States

  • GSK Investigational Site

    Dallas, Texas, 75246, United States

  • GSK Investigational Site

    Brussels, 1000, Belgium

  • GSK Investigational Site

    Ghent, 9000, Belgium

  • GSK Investigational Site

    Aarhus, 8200, Denmark

  • GSK Investigational Site

    Hvidovre, 2650, Denmark

  • GSK Investigational Site

    Rotterdam, 3015 GD, Netherlands

  • GSK Investigational Site

    Barcelona, 08003, Spain

  • GSK Investigational Site

    Barcelona, 08026, Spain

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Barcelona, 08916, Spain

  • GSK Investigational Site

    Barcelona, 8907, Spain

  • GSK Investigational Site

    Córdoba, 14004, Spain

  • GSK Investigational Site

    La Laguna Santa Cruz, 38320, Spain

  • GSK Investigational Site

    Madrid, 28020, Spain

  • GSK Investigational Site

    Madrid, 28031, Spain

  • GSK Investigational Site

    Madrid, 28034, Spain

  • GSK Investigational Site

    Madrid, 28040, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 28046, Spain

  • GSK Investigational Site

    Madrid, 28224, Spain

  • GSK Investigational Site

    Palma de Mallorca, 07120, Spain

  • GSK Investigational Site

    Palma de Mallorca, 7198, Spain

  • GSK Investigational Site

    Seville, 41013, Spain

  • GSK Investigational Site

    Valencia, 46014, Spain

  • GSK Investigational Site

    Valencia, 46026, Spain

  • GSK Investigational Site

    London, NW3 2QG, United Kingdom

  • GSK Investigational Site

    London, SE1 7EH, United Kingdom

  • GSK Investigational Site

    London, W2 1NY, United Kingdom

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