NCT07053384

Brief 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 inhibitor (INSTI)-based antiretroviral therapy (ART) regimen (Population 2).

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
27mo left

Started Jul 2025

Typical duration for phase_1 hiv-infections

Geographic Reach
6 countries

41 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Jul 2025Sep 2028

First Submitted

Initial submission to the registry

June 26, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

July 10, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2027

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2028

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

June 26, 2025

Last Update Submit

March 23, 2026

Conditions

HIV Infections

Keywords

VH3810109N6LSBroadly neutralizing antibody (bNAb)Fostemsavir (FTR)RUKOBIAINSTI-based ARTHuman Immunodeficiency Virus (HIV)HIV reservoirAdults living with HIV

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in cell-associated HIV-1 RNA transcripts per million cluster of differentiation 4 (CD4+) T cells

    From Baseline (Day 1) to Month 12

Secondary Outcomes (8)

  • Change from baseline in total, intact, and defective proviral HIV-1 DNA per million CD4+ T cells

    From Baseline (Day 1) to Month 12

  • Absolute change in cell-associated HIV-1 RNA/proviral DNA ratios in CD4+ T cells

    From Baseline (Day 1) to Month 12

  • Absolute values for p24+ CD4+ T cell count

    From Baseline (Day 1) to Month 12

  • Change from baseline in number of p24+ CD4+ T cells

    From Baseline (Day 1) to Month 12

  • Absolute values for HIV-1-specific CD8+ T cell count

    From Baseline (Day 1) to Month 12

  • +3 more secondary outcomes

Study Arms (3)

Participants receiving standard of care (SOC) integrase strand transfer inhibitor (INSTI)-based ART

ACTIVE COMPARATOR
Drug: SOC INSTI-based ART

Participants receiving SOC INSTI-based ART plus VH3810109

EXPERIMENTAL
Biological: VH3810109Drug: SOC INSTI-based ART

Participants receiving SOC INSTI-based ART plus VH3810109 plus FTR

EXPERIMENTAL
Biological: VH3810109Drug: Fostemsavir (FTR)Drug: SOC INSTI-based ART

Interventions

VH3810109BIOLOGICAL

VH3810109 will be administered.

Participants receiving SOC INSTI-based ART plus VH3810109Participants receiving SOC INSTI-based ART plus VH3810109 plus FTR
Fostemsavir (FTR)DRUG

Fostemsavir will be administered.

Also known as: RUKOBIA
Participants receiving SOC INSTI-based ART plus VH3810109 plus FTR
SOC INSTI-based ARTDRUG

A SOC INSTI-based ART regimen will be administered.

Participants receiving SOC INSTI-based ART plus VH3810109Participants receiving SOC INSTI-based ART plus VH3810109 plus FTRParticipants receiving standard of care (SOC) integrase strand transfer inhibitor (INSTI)-based ART

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 years and 70 years old at the time of obtaining informed consent.
  • 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 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.
  • Body weight \>=50 kg to \<=115 kg.
  • 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.
  • +44 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

GSK Investigational Site

Bakersfield, California, 93301, United States

Location

GSK Investigational Site

San Diego, California, 92103, United States

Location

GSK Investigational Site

Ft. Pierce, Florida, 34982, United States

Location

GSK Investigational Site

Orlando, Florida, 32803, United States

Location

GSK Investigational Site

Chicago, Illinois, 60611, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64111, United States

Location

GSK Investigational Site

St Louis, Missouri, 63110, United States

Location

GSK Investigational Site

New York, New York, 10032, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45267, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

GSK Investigational Site

Dallas, Texas, 75208, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Brussels, 1000, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Aarhus, 8200, Denmark

Location

GSK Investigational Site

Hvidovre, 2650, Denmark

Location

GSK Investigational Site

Rotterdam, 3015 GD, Netherlands

Location

GSK Investigational Site

Barcelona, 08003, Spain

Location

GSK Investigational Site

Barcelona, 08026, Spain

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Barcelona, 08916, Spain

Location

GSK Investigational Site

Barcelona, 8907, Spain

Location

GSK Investigational Site

Córdoba, 14004, Spain

Location

GSK Investigational Site

La Laguna Santa Cruz, 38320, Spain

Location

GSK Investigational Site

Madrid, 28020, Spain

Location

GSK Investigational Site

Madrid, 28031, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Madrid, 28224, Spain

Location

GSK Investigational Site

Palma de Mallorca, 07120, Spain

Location

GSK Investigational Site

Palma de Mallorca, 7198, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

GSK Investigational Site

Valencia, 46014, Spain

Location

GSK Investigational Site

Valencia, 46026, Spain

Location

GSK Investigational Site

London, NW3 2QG, United Kingdom

Location

GSK Investigational Site

London, SE1 7EH, United Kingdom

Location

GSK Investigational Site

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

fostemsavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 8, 2025

Study Start

July 10, 2025

Primary Completion (Estimated)

January 22, 2027

Study Completion (Estimated)

September 6, 2028

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
More information

Locations

DK(2)US(13)BE(2)GB(3)NL(1)ES(20)