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HIV InfectionsPhase 1ENTRANCENCT07053384

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

A Phase 1 study testing VH3810109, Fostemsavir (FTR) and SOC INSTI-based ART in people with HIV Infections, run by ViiV Healthcare at 41 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
HIV Infections
What is being tested?
VH3810109, Fostemsavir (FTR) and SOC INSTI-based ART
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
41 sitesin 6 countries
Study dates
10 Jul 2025to 6 Sep 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.
Show all 62Show fewer
  • 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.

Trial locations and contacts

41 sites in 6 countries.

41 sites in 6 countries

Spain20 sites

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08026

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Barcelona, 08916

  • GSK Investigational Site

    Barcelona, 8907

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    La Laguna Santa Cruz, 38320

  • GSK Investigational Site

    Madrid, 28020

  • GSK Investigational Site

    Madrid, 28031

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Palma de Mallorca, 07120

  • GSK Investigational Site

    Palma de Mallorca, 7198

  • GSK Investigational Site

    Pozuelo de Alarcón, Madrid, 28224

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Valencia, 46014

  • GSK Investigational Site

    Valencia, 46026

Other trials in Spain

United States13 sites

  • GSK Investigational Site

    Bakersfield, California, 93309

  • GSK Investigational Site

    Chicago, Illinois, 60611

  • GSK Investigational Site

    Cincinnati, Ohio, 45267

  • GSK Investigational Site

    Dallas, Texas, 75208-4599

  • GSK Investigational Site

    Dallas, Texas, 75246-2004

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982-7148

  • GSK Investigational Site

    Kansas City, Missouri, 64111

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    Orlando, Florida, 32803-1851

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    St Louis, Missouri, 63110

Other trials in United States

United Kingdom3 sites

  • GSK Investigational Site

    London, NW3 2QG

  • GSK Investigational Site

    London, SE1 7EH

  • GSK Investigational Site

    London, W2 1NY

Other trials in United Kingdom

Belgium2 sites

  • GSK Investigational Site

    Brussels, 1000

  • GSK Investigational Site

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

Denmark2 sites

  • GSK Investigational Site

    Aarhus N, Central Jutland, 8200

  • GSK Investigational Site

    Hvidovre, Capital Region, 2650

Other trials in Denmark

Netherlands1 site

  • GSK Investigational Site

    Rotterdam, 3015 GD

Other trials in Netherlands

About this study

Official title: An Exploratory Phase 1b, Multicenter, Randomized, Open-Label Study to Investigate the Impact of the Administration of Intravenous VH3810109 With or Without Oral Fostemsavir in Combination With Integrase Inhibitor-Based Antiretroviral Therapy on the Viral Reservoir in Adults Living With HIV-1

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).

Conditions
HIV Infections
Being tested
VH3810109, Fostemsavir (FTR), SOC INSTI-based ART
Keywords
VH3810109, N6LS, Lotivibart (LVB), Broadly neutralizing antibody (bNAb), Fostemsavir (FTR), RUKOBIA, INSTI-based ART, Human Immunodeficiency Virus (HIV), HIV reservoir, Adults living with HIV, Analytical Treatment Interruption (ATI)
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VH3810109Biological

    Also called Lotivibart (LVB)

    VH3810109 will be administered.

  • Fostemsavir (FTR)Drug

    Also called RUKOBIA

    Fostemsavir will be administered.

  • SOC INSTI-based ARTDrug

    A SOC INSTI-based ART regimen will be administered.

Study groups in NCT07053384
Study groupRoleWhat they receive
Participants receiving SOC INSTI-based ART in Randomized Intervention Phase (Step 1)Active comparatorNot described
Receives: Drug: SOC INSTI-based ART
Participants receiving SOC INSTI-based ART+VH3810109 in Randomized Intervention Phase (Step 1)ExperimentalNot described
Receives: Biological: VH3810109; Drug: SOC INSTI-based ART
Participants receiving SOC INSTI-based ART+VH3810109+FTR in Randomized Intervention Phase (Step 1)ExperimentalNot described
Receives: Biological: VH3810109; Drug: Fostemsavir (FTR); Drug: SOC INSTI-based ART
Participants receiving VH3810109 in ATI Phase (Step 2)ExperimentalNot described
Receives: Biological: VH3810109

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Randomized Intervention Phase (Step 1): Change from baseline in cell-associated HIV-1 RNA transcripts per million cluster of differentiation 4 (CD4+) T cells

    Measured: From Baseline (Day 1) to Month 12

Secondary outcomes (10)

  1. Randomized Intervention Phase (Step 1): Change from baseline in total, intact, and defective proviral HIV-1 DNA per million CD4+ T cells

    Measured: From Baseline (Day 1) to Month 12

  2. Randomized Intervention Phase (Step 1): Absolute change in cell-associated HIV-1 RNA/proviral DNA ratios in CD4+ T cells

    Measured: From Baseline (Day 1) to Month 12

  3. Randomized Intervention Phase (Step 1): Absolute values for HIV-1-specific CD8+ T cell count

    Measured: From Baseline (Day 1) to Month 12

  4. Randomized Intervention Phase (Step 1): Change from baseline in HIV-1-specific CD8+ T cell count

    Measured: From Baseline (Day 1) to Month 12

  5. Randomized Intervention Phase (Step 1): Number of participants with Grade 3 and Grade 4 adverse events (AEs)

    Measured: From Baseline (Day 1) to Month 15

  6. Randomized Intervention Phase (Step 1): Number of participants with serious adverse events (SAEs), deaths and AEs leading to discontinuation of study intervention

    Measured: From Baseline (Day 1) to Month 15

  7. ATI Phase (Step 2): Time to ART restart

    Measured: From Day 1A to Week 24A (ATI Phase Alpha) and Week 48A (ATI Phase Gamma)

  8. ATI Phase (Step 2): Number of participants with Grade 3 and Grade 4 AEs

    Measured: From Day 1A to Week 24A (ATI Phase Alpha) and Week 48A (ATI Phase Gamma)

  9. ATI Phase (Step 2): Number of participants with SAEs and deaths

    Measured: From Day 1A to Week 24A (ATI Phase Alpha) and Week 48A (ATI Phase Gamma)

  10. ATI Phase (Step 2): Number of participants with disease progression (HIV-associated conditions, acquired immunodeficiency syndrome [AIDS] and death)

    Measured: From Day 1A to Week 24A (ATI Phase Alpha) and Week 48A (ATI Phase Gamma)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2025
  2. Study start10 Jul 2025
  3. Primary completion22 Jan 2027 (estimated)
  4. Study completion6 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07053384
Sponsor's protocol ID
221794
Other IDs
2025-520629-19-00, 2025
Acronym
ENTRANCE
Status last verified
Sep 2026
First submitted
26 Jun 2025
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VH3810109, Fostemsavir (FTR) and SOC INSTI-based ART in people with HIV Infections, run by ViiV Healthcare at 41 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 62 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Spain, United States, United Kingdom, Belgium, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Randomized Intervention Phase (Step 1): Change from baseline in cell-associated HIV-1 RNA transcripts per million cluster of differentiation 4 (CD4+) T cells (time frame: From Baseline (Day 1) to Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07053384.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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