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

May 7, 2026 updated by: ViiV Healthcare

A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of Oral VH4524184 Coadministered With Emtricitabine and Tenofovir Alafenamide in Treatment Naive Viremic Persons With HIV-1 (INNOVATE Study)

This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1023
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Veronica Lacal Ridilenir
      • Buenos Aires, Argentina, C1425AGC
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guillermina Maria Roveda Vergés
      • Buenos Aires, Argentina, 1427
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pedro Cahn
      • Ciudad Autonoma Buenos Aires, Argentina, C1002ABJ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gustavo Lopardo
      • Ciudad Autonoma de Bueno, Argentina, 1405
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ezequiel Cordova
      • Mar del Plata, Argentina, B7600FZO
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gonzalo Corral
      • San Miguel de Tucumán, Argentina, T4000IHE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Gonzalo Tomas
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark Bloch
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ian Woolley
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • James McMahon
  • Belgium
      • Antwerp, Belgium, 2000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jelle Visser
      • Brussels, Belgium, 1000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin Vandeputte
      • Ghent, Belgium, 9000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marie-Angélique De Scheerder
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Cox
      • Montreal, Quebec, Canada, H2L 4P9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jason Szabo
  • France
      • Nantes, France, 44093
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Colin Deschanvres
      • Nîmes, France, 30029
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paul Loubet
        • Contact:
        • Contact:
      • Paris, France, 75012
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • karine lacombe
        • Contact:
        • Contact:
  • Germany
      • Berlin, Germany, 10787
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hartmut Stocker
      • Cologne, Germany, 50937
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Clara Lehmann
        • Contact:
        • Contact:
      • Frankfurt, Germany, 60590
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christoph Stephan
      • Hamburg, Germany, 20146
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Hoffmann
      • München, Germany, 80337
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sebastian Noe
  • Italy
      • Bergamo, Italy, 24127
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Diego Ripamonti
      • Milan, Italy, 20122
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alessandra Bandera
      • Milan, Italy, 20127
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Antonella Castagna
        • Contact:
        • Contact:
      • Milan, Italy, 20142
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giulia Carla Marchetti
      • Milan, Italy, 20157
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrea Gori
      • Palermo, Italy, 90127
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonio Cascio
      • Roma, Italy
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlo Torti
      • Roma, Italy, 00149
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Andrea Antinori
        • Contact:
        • Contact:
  • Japan
      • Fukuoka, Japan, 810-8563
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rumi Minami
      • Kanagawa, Japan, 221-0855
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yukihiro Yoshimura
      • Okinawa, Japan, 901-2725
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hideta Nakamura
      • Osaka, Japan, 540-0006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dai Watanabe
      • Osaka, Japan, 534-0021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michinori Shirano
      • Tokyo, Japan, 162-8655
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hiroyuki Gatanaga
      • Tokyo, Japan, 160-0023
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ei Kinai
  • Poland
      • Bydgoszcz, Poland, 85-030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anita Olczak
      • Gdansk, Poland, 80-405
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Maria Hlebowicz
        • Contact:
        • Contact:
  • Portugal
      • Gaia, Portugal, 4434-502
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Coutinho
      • Porto, Portugal, 4099-001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Josefina Mendez
      • Porto, Portugal, 4200-319
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rosario Serrao
  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Álvaro Mena de Cea
      • Alicante, Spain, 03010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sergio Reus Bañuls
      • Almeira, Spain, 04009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonio Collado
      • Badalona, Spain, 08916
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eugenia Negredo Puigmal
      • Barcelona, Spain, 08003
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • roberto carlos guerri
      • Barcelona, Spain, 08036
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Josep Mallolas Masferrer
      • Barcelona, Spain, 08041
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paula Prieto
      • Barcelona, Spain, 08097
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Maria Saumoy Linares
        • Contact:
        • Contact:
      • Barcelona, Spain, 08830
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vicens Díaz de Brito Fernández
      • Elche Alicante, Spain, 03203
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • MAR MASIA
        • Contact:
        • Contact:
      • Getafe, Spain, 28905
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Javier Esteban Fernández
      • Granada, Spain, 18014
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carmen Hidalgo Tenorio
      • HebrOn, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jordi Navarro Mercadé
      • Madrid, Spain, 28031
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guillermo Cuevas
      • Madrid, Spain, 28046
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Gonzalez-Garcia
      • Madrid, Spain, 28040
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miguel Górgolas
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Otilia Bisbal Pardo
      • Madrid, Spain, 28007
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Tejerina Picado
      • Madrid, Spain, 28006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ignacio de los Santos Gil
      • Madrid, Spain, 28020
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Vicente Estrada
        • Contact:
        • Contact:
      • Marbella, Spain, 29603
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julian Olalla
      • Murcia, Spain, 30003
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Enrique Bernal Morell
      • Málaga, Spain, 29010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rosario Palacios Muñoz
      • Palma de Mallorca, Spain, 07120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Fanjul Losa
      • Palma de Mallorca, Spain, 07198
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aroa Villoslada Gelabert
      • Sabadell Barcelona, Spain, 08208
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mª Carmen Navarro Saez
      • Santa Cruz de Tenerife, Spain, 38320
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • María Remedios Alemán Valls
      • Santander, Spain, 39011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Del Carmen Farinas Alvarez
      • Seville, Spain, 41013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luis Fernando López Cortés
      • Seville, Spain, 41014
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Macias
      • Valencia, Spain, 46026
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marta Montero
      • Valencia, Spain, 46014
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miguel García Deltoro
      • Vigo Pontevedra, Spain, 36312
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luis Morano Amado
      • Zaragoza, Spain, 50009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • María Crusells Canales
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Po-Liang Lu
      • Kaohsiung City, Taiwan, 813
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hungchin Tsai
      • Taipei, Taiwan, 11217
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ping-Feng Wu
      • Taoyuan, Taiwan, 330
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • CHIEN-YU CHENG
  • United States
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Franco Felizarta
      • Palm Springs, California, United States, 92262
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cyril Gaultier
      • West Hollywood, California, United States, 90046
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Manuel Pardo
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Campbell
    • Connecticut
      • New Haven, Connecticut, United States, 06501
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Onyema Ogbuagu
    • Florida
      • Ft. Pierce, Florida, United States, 34982
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Moti Ramgopal
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paula Eckardt
      • Miami, Florida, United States, 33136
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dushyantha Jayaweera
      • Miami Gardens, Florida, United States, 33055
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jessica Altamirano
        • Contact:
        • Contact:
      • Oakland Park, Florida, United States, 33334
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Noah Lee
      • Orlando, Florida, United States, 32803
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Roberto Ortiz
        • Contact:
        • Contact:
      • West Palm Beach, Florida, United States, 33409
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hector Bolivar
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Caitlin Moran
      • Macon, Georgia, United States, 31201
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Harold Katner
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anupama Raghuram
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dima Dandachi
        • Contact:
        • Contact:
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Blair Thedinger
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sara Bares
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jihad Slim
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexandra Abrams-Downey
      • Manhasset, New York, United States, 11030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph McGowan
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marc Johnson
      • Greensboro, North Carolina, United States, 27401
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cornelius Van Dam
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthew Sincock
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carl Fichtenbaum
    • Texas
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • James Sims III
      • Dallas, Texas, United States, 75246
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Clinton Haley
      • Houston, Texas, United States, 77030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Divya Bhamidipati
      • Houston, Texas, United States, 77025
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeannette Ouyang-Latimer
      • Longview, Texas, United States, 75605
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anita Scribner
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rachel Bender-Ignacio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participant must be at least 18 years of age (or older, if required for adults by local regulations) at the time of signing the informed consent.
  2. Screening CD4+ T-cell count >200 cells/microlitre (µL).
  3. Documented HIV-1 infection and Screening plasma HIV-1 RNA of ≥1000 copies/millilitre (mL). A single repeat of this test is allowed within a single Screening period to determine eligibility.
  4. Treatment-naive: Defined as no ARVs (in combination or monotherapy) received after the diagnosis of HIV-1 infection.
  5. Body weight >=50.0 kilogram (kg) [(110 pounds (lbs)] for participants assigned male at birth and >=45.0 kg (99 lbs) for participants assigned female at birth. BMI within the range 18.5-35.5 kg/m^2 (inclusive - applies to males and females).
  6. There are no contraceptive requirements for participants assigned male at birth.

  7. Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding and one of the following conditions applies:

    • Is a Participant of non-childbearing potential (PONCBP);OR Is a Participant of childbearing potential (POCBP) and using a contraceptive method with a failure rate of less than (<) 1% prior to and during the study intervention period, and for at least 1 week after the last dose of VH4524184 plus FTC/TAF FDC, or through the end of study (if in the control arm and never received VH4524184).
    • A POCBP must have a negative pregnancy test at Screening (serum) and on Day 1 (urine) before the first dose of study intervention.
    • If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. Participant with a positive serum test must be excluded.
  8. Capable of giving signed informed consent.

Exclusion Criteria:

  1. Participants who are breastfeeding or plan to breastfeed during the study.
  2. Participants with acute HIV infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc.) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion.
  3. Any evidence of an active Centres for Disease Control and Prevention (CDC) Stage 3 disease [CDC 2014], except cutaneous Kaposi's sarcoma not requiring systemic therapy during the study. Historical CD4+ cell counts less than 200 cells/µL are not exclusionary.
  4. Unstable liver disease known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
  5. History of cirrhosis with or without viral hepatitis co-infection.
  6. Participants with HCV co-infection will be excluded from the study.
  7. Individuals who are co-infected with HIV and HBV will be excluded Participants diagnosed with syphilis at Screening (i.e., positive syphilis testing) should be treated as per local guidelines and will be eligible to enroll at any time regardless of the stage of disease.
  8. Uncontrolled malignancy is excluded, whereas participants who have controlled malignancies may be included in agreement between the investigator and the ViiV Healthcare medical monitor.
  9. Any pre-existing physical, or mental condition (including alcohol or drug abuse) which, in the opinion of the investigator (with or without psychiatric evaluation) or the ViiV Healthcare medical monitor, 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.
  10. Any condition which, in the opinion of the investigator or the ViiV Healthcare medical monitor, that may interfere with the absorption, distribution, metabolism or excretion of the study interventions or render the participant unable to take oral medication and normal gastrointestinal anatomy or motility or hepatic and/or renal function
  11. Clinically significant CV disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
  12. Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
  13. History of sensitivity to any of the study medications, or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or ViiV Healthcare medical monitor, contraindicates their participation.
  14. Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
  15. Treatment with any of the following agents within 60 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.
  16. Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of Day 1.
  17. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
  18. Exposure to an approved vaccine within 14 days prior to Day 1.
  19. Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research
  20. Participants with known or suspected presence of virologic resistance mutations as defined by the Stanford HIV Drug Resistance Database to INSTIs or NRTIs. This determination will be based on local virologic resistance testing, either at Screening or within the 3 months prior to Screening. ViiV Healthcare clinical virologist and/or ViiV Healthcare medical monitor will verify eligibility to this criterion prior to Day 1.
  21. Creatinine clearance (eGFR) of <60 mL/min/1.73 m2 via CKD-EPI race neutral method [Delgado, 2021].
  22. ALT >3 times the upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility.
  23. Any Grade 4 laboratory abnormality at screening, except for a Grade 4 CPK and lipid abnormalities (e.g., total cholesterol, triglycerides, etc.) will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the ViiV Healthcare medical monitor. A single repeat of any lab abnormality is allowed within a single screening period to determine eligibility.
  24. Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
  25. Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination and will be the screening ECG entered into the eCRF): QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 msec (males) or >470 msec (females); >480 msec for participants with bundle branch block.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VH4524184 Dose A+ FTC / TAF
Participants receive a daily oral dose of VH4524184 Dose A (Low dose) in combination with a fixed dose containing FTC/TAF starting Day 1 until Month 12.
Drug: VH4524184
Oral tablet will be administered.
Drug: Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets
Oral table will be administered.
Other Names:
  • DESCOVY
Experimental: VH4524184 Dose B + FTC / TAF
Participants receive a daily oral dose of VH4524184 Dose B (High dose) in combination with a fixed dose containing FTC / TAF beginning on Day 1 until the Month 12.
Drug: VH4524184
Oral tablet will be administered.
Drug: Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets
Oral table will be administered.
Other Names:
  • DESCOVY
Active Comparator: DTG + 3TC
Participants receive a daily oral dose of DTG and 3TC (fixed dose combination) from Day 1 through Month 24.
Drug: Dolutegravir / Lamivudine (DTG/3TC)
Oral tablets will be administered.
Other Names:
  • DOVATO
Experimental: VH4524184 selected dose + FTC / TAF
Participants receive a selected dose of VH4524184, combined with FTC/TAF, orally once daily from to Month 12 to Month 24.
Drug: VH4524184
Oral tablet will be administered.
Drug: Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets
Oral table will be administered.
Other Names:
  • DESCOVY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Achieving Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Suppression (<50 copies/millilitre) as per FDA Snapshot Methodology
Time Frame: At Month 12
At Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Maintaining Plasma HIV-1 RNA Suppression (<50 copies/mL) Based on Observed Laboratory Results
Time Frame: Day 1 to Month 24
Day 1 to Month 24
Percentage of Participants Achieving Plasma HIV-1 RNA Suppression (<50 copies/ml) as per FDA Snapshot Methodology
Time Frame: Day 1 to Month 24
Day 1 to Month 24
Change From Baseline in Cluster of Differentiation 4 (CD4+) T-cell Counts
Time Frame: Day 1 to Month 24
Blood samples will be collected for assessment of T-cells subsets (CD4+ T-cells count) by flow cytometry.
Day 1 to Month 24
Number of Participants with Any Adverse Event (AE)
Time Frame: Day 1 to Month 24
Day 1 to Month 24
Number of Participants with AEs by Severity
Time Frame: Day 1 to Month 24
The severity will be assessed using The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.1 where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening and Grade 5 = Death.
Day 1 to Month 24
Number of Participants with AEs Leading to Study Treatment Discontinuation
Time Frame: Day 1 to Month 24
Day 1 to Month 24
Plasma Concentration of VH4524184
Time Frame: Day 1 to Month 24
Blood samples will be collected at indicated time point for PK analysis of VH4524184.
Day 1 to Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2026

Primary Completion (Estimated)

July 26, 2027

Study Completion (Estimated)

July 24, 2028

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

September 30, 2025

First Posted (Actual)

October 2, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 222638
  • 2025-521918-26-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sudy 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

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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