Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New HIV pill combo shows promise in early trial

NCT ID NCT07202546

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Updated 2 times

Summary

This study is testing a new experimental drug called VH4524184 for people with HIV-1 who have never taken HIV medication before. About 150 adults will receive either a low or high dose of VH4524184 along with two standard HIV drugs (emtricitabine and tenofovir alafenamide), or a standard three-drug regimen. The goal is to see how well the new drug combination suppresses the virus and to gather safety information.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 186 people

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

Started

Feb 2026

Expected to finish

May 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 years and older

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: 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. Persons who are placed in an institution by order of a public authority or a court are excluded from participation in this study. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HIV infections are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

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

HIV infections

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    123 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Bakersfield, California, 93301, United States

  • GSK Investigational Site

    RECRUITING

    Palm Springs, California, 92262, United States

  • GSK Investigational Site

    RECRUITING

    West Hollywood, California, 90046, United States

  • GSK Investigational Site

    RECRUITING

    Aurora, Colorado, 80045, United States

  • GSK Investigational Site

    RECRUITING

    New Haven, Connecticut, 06501, United States

  • GSK Investigational Site

    RECRUITING

    Ft. Pierce, Florida, 34982, United States

  • GSK Investigational Site

    RECRUITING

    Hollywood, Florida, 33021, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33136, United States

  • GSK Investigational Site

    RECRUITING

    Miami Gardens, Florida, 33055, United States

  • GSK Investigational Site

    RECRUITING

    Oakland Park, Florida, 33334, United States

  • GSK Investigational Site

    RECRUITING

    Orlando, Florida, 32803, United States

  • GSK Investigational Site

    RECRUITING

    Orlando, Florida, 32803, United States

  • GSK Investigational Site

    RECRUITING

    West Palm Beach, Florida, 33409, United States

  • GSK Investigational Site

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • GSK Investigational Site

    RECRUITING

    Macon, Georgia, 31201, United States

  • GSK Investigational Site

    RECRUITING

    Chicago, Illinois, 60637, United States

  • GSK Investigational Site

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • GSK Investigational Site

    RECRUITING

    Columbia, Missouri, 65212, United States

  • GSK Investigational Site

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • GSK Investigational Site

    RECRUITING

    Omaha, Nebraska, 68106, United States

  • GSK Investigational Site

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • GSK Investigational Site

    RECRUITING

    Newark, New Jersey, 07102, United States

  • GSK Investigational Site

    RECRUITING

    Albany, New York, 12208, United States

  • GSK Investigational Site

    RECRUITING

    Manhasset, New York, 11030, United States

  • GSK Investigational Site

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • GSK Investigational Site

    RECRUITING

    Durham, North Carolina, 27710, United States

  • GSK Investigational Site

    RECRUITING

    Greensboro, North Carolina, 27401, United States

  • GSK Investigational Site

    RECRUITING

    Wilmington, North Carolina, 28401, United States

  • GSK Investigational Site

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • GSK Investigational Site

    RECRUITING

    Bellaire, Texas, 77401, United States

  • GSK Investigational Site

    RECRUITING

    Dallas, Texas, 75246, United States

  • GSK Investigational Site

    RECRUITING

    Houston, Texas, 77025, United States

  • GSK Investigational Site

    RECRUITING

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    RECRUITING

    Longview, Texas, 75605, United States

  • GSK Investigational Site

    RECRUITING

    Seattle, Washington, 98104, United States

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, 1023, Argentina

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, 1427, Argentina

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, C1425AGC, Argentina

  • GSK Investigational Site

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1002ABJ, Argentina

  • GSK Investigational Site

    RECRUITING

    Ciudad Autonoma de Bueno, 1405, Argentina

  • GSK Investigational Site

    RECRUITING

    Mar del Plata, B7600FZO, Argentina

  • GSK Investigational Site

    RECRUITING

    San Miguel de Tucumán, T4000IHE, Argentina

  • GSK Investigational Site

    RECRUITING

    Sydney, New South Wales, 2010, Australia

  • GSK Investigational Site

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • GSK Investigational Site

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • GSK Investigational Site

    RECRUITING

    Antwerp, 2000, Belgium

  • GSK Investigational Site

    RECRUITING

    Brussels, 1000, Belgium

  • GSK Investigational Site

    RECRUITING

    Ghent, 9000, Belgium

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H2L 4P9, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • GSK Investigational Site

    RECRUITING

    Bordeaux, 33000, France

  • GSK Investigational Site

    RECRUITING

    Caen, 14033, France

  • GSK Investigational Site

    RECRUITING

    Nantes, 44093, France

  • GSK Investigational Site

    RECRUITING

    Nîmes, 30029, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75012, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75013, France

  • GSK Investigational Site

    RECRUITING

    Berlin, 10787, Germany

  • GSK Investigational Site

    RECRUITING

    Cologne, 50937, Germany

  • GSK Investigational Site

    RECRUITING

    Frankfurt, 60590, Germany

  • GSK Investigational Site

    RECRUITING

    Hamburg, 20146, Germany

  • GSK Investigational Site

    RECRUITING

    München, 80337, Germany

  • GSK Investigational Site

    RECRUITING

    Bergamo, 24127, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, 20122, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, 20127, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, 20142, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, 20157, Italy

  • GSK Investigational Site

    RECRUITING

    Roma, 00149, Italy

  • GSK Investigational Site

    RECRUITING

    Roma, Italy

  • GSK Investigational Site

    RECRUITING

    Fukuoka, 810-8563, Japan

  • GSK Investigational Site

    RECRUITING

    Kanagawa, 221-0855, Japan

  • GSK Investigational Site

    RECRUITING

    Okinawa, 901-2725, Japan

  • GSK Investigational Site

    RECRUITING

    Osaka, 534-0021, Japan

  • GSK Investigational Site

    RECRUITING

    Osaka, 540-0006, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 108-8639, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 160-0023, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 162-8655, Japan

  • GSK Investigational Site

    RECRUITING

    Bydgoszcz, 85-030, Poland

  • GSK Investigational Site

    RECRUITING

    Gdansk, 80-405, Poland

  • GSK Investigational Site

    RECRUITING

    Porto, 4099-001, Portugal

  • GSK Investigational Site

    RECRUITING

    Porto, 4200-319, Portugal

  • GSK Investigational Site

    RECRUITING

    Vila Nova de Gaia, 4434-502, Portugal

  • GSK Investigational Site

    RECRUITING

    Daegu, 700-721, South Korea

  • GSK Investigational Site

    RECRUITING

    Gwangju, 61469, South Korea

  • GSK Investigational Site

    RECRUITING

    Pusan, 49241, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 03722, South Korea

  • GSK Investigational Site

    RECRUITING

    A Coruña, 15006, Spain

  • GSK Investigational Site

    RECRUITING

    Alicante, 03010, Spain

  • GSK Investigational Site

    RECRUITING

    Almería, 04009, Spain

  • GSK Investigational Site

    RECRUITING

    Badalona, 08916, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08003, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08036, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08041, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08097, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08830, Spain

  • GSK Investigational Site

    RECRUITING

    Elche Alicante, 03203, Spain

  • GSK Investigational Site

    RECRUITING

    Getafe, 28905, Spain

  • GSK Investigational Site

    RECRUITING

    Granada, 18014, Spain

  • GSK Investigational Site

    RECRUITING

    HebrOn, 08035, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28006, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28007, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28020, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28031, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28040, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28041, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28046, Spain

  • GSK Investigational Site

    RECRUITING

    Marbella, 29603, Spain

  • GSK Investigational Site

    RECRUITING

    Málaga, 29010, Spain

  • GSK Investigational Site

    RECRUITING

    Murcia, 30003, Spain

  • GSK Investigational Site

    RECRUITING

    Palma de Mallorca, 07120, Spain

  • GSK Investigational Site

    RECRUITING

    Palma de Mallorca, 07198, Spain

  • GSK Investigational Site

    RECRUITING

    Sabadell Barcelona, 08208, Spain

  • GSK Investigational Site

    RECRUITING

    Santa Cruz de Tenerife, 38320, Spain

  • GSK Investigational Site

    RECRUITING

    Santander, 39011, Spain

  • GSK Investigational Site

    RECRUITING

    Seville, 41013, Spain

  • GSK Investigational Site

    RECRUITING

    Seville, 41014, Spain

  • GSK Investigational Site

    RECRUITING

    Valencia, 46014, Spain

  • GSK Investigational Site

    RECRUITING

    Valencia, 46026, Spain

  • GSK Investigational Site

    RECRUITING

    Vigo Pontevedra, 36312, Spain

  • GSK Investigational Site

    RECRUITING

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • GSK Investigational Site

    RECRUITING

    Kaohsiung City, 813, Taiwan

  • GSK Investigational Site

    RECRUITING

    Taipei, 11217, Taiwan

  • GSK Investigational Site

    RECRUITING

    Taoyuan, 330, Taiwan

More trials for these conditions

Other studies related to the condition(s) this trial covers.