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New Ultra-Long-Acting HIV shots could mean fewer doses for patients

NCT ID NCT07650916

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 3 times

Summary

This study tests whether a new ultra-long-acting injectable HIV medication works as well as the current long-acting version. About 564 adults and teens with well-controlled HIV will receive either the ultra-long-acting or the standard long-acting shots. The goal is to see if the new option can keep the virus suppressed with fewer injections.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 564 people

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

Started

Jun 2026

Expected to finish

Sep 2029

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

12 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: Patient Study Participant (PSP) Inclusion criteria: * Adults and adolescents with HIV-1 infection aged 12 years or older with a weight \>35 kg. * Documented HIV-1 RNA measurements \<50 copies/mL in the 12 months prior to Screening. * HIV-1 RNA \<50 copies/mL at screening assessment. * Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening. * Any prior switch in therapy must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies/mL). Exclusion criteria: Patient Study Participant (PSP) Exclusion criteria: * Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation. * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening. * Any history of receiving long-acting therapy for HIV. * Previous exposure to CAB and/or RPV for treatment or prevention of HIV-1 infection. * Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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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

    88 sites in 9 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

    Phoenix, Arizona, 85015, United States

  • GSK Investigational Site

    RECRUITING

    Bakersfield, California, 93301, United States

  • GSK Investigational Site

    RECRUITING

    Los Angeles, California, 90027, United States

  • GSK Investigational Site

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    Los Angeles, California, 90036, United States

  • GSK Investigational Site

    RECRUITING

    San Diego, California, 92103, United States

  • GSK Investigational Site

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • GSK Investigational Site

    RECRUITING

    Washington D.C., District of Columbia, 20017, United States

  • GSK Investigational Site

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    DeLand, Florida, 32720, United States

  • GSK Investigational Site

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    Fort Lauderdale, Florida, 33316, United States

  • GSK Investigational Site

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    Ft. Pierce, Florida, 34982, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33136, United States

  • GSK Investigational Site

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    Orlando, Florida, 32803, United States

  • GSK Investigational Site

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    Pensacola, Florida, 32503, United States

  • GSK Investigational Site

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    Vero Beach, Florida, 32960, United States

  • GSK Investigational Site

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • GSK Investigational Site

    RECRUITING

    West Palm Beach, Florida, 33409, United States

  • GSK Investigational Site

    RECRUITING

    Decatur, Georgia, 30033, United States

  • GSK Investigational Site

    RECRUITING

    Grosse Pointe Woods, Michigan, 48236, United States

  • GSK Investigational Site

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • GSK Investigational Site

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    Las Vegas, Nevada, 89101, United States

  • GSK Investigational Site

    RECRUITING

    Newark, New Jersey, 07102, United States

  • GSK Investigational Site

    RECRUITING

    Santa Fe, New Mexico, 87505, United States

  • GSK Investigational Site

    RECRUITING

    Stony Brook, New York, 11794, United States

  • GSK Investigational Site

    RECRUITING

    Syracuse, New York, 13057, United States

  • GSK Investigational Site

    RECRUITING

    Greensboro, North Carolina, 27401, United States

  • GSK Investigational Site

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    Columbus, Ohio, 43210, United States

  • GSK Investigational Site

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    Philadelphia, Pennsylvania, 19104, United States

  • GSK Investigational Site

    RECRUITING

    Austin, Texas, 78705, United States

  • GSK Investigational Site

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    Dallas, Texas, 75219, United States

  • GSK Investigational Site

    RECRUITING

    Dallas, Texas, 75246, United States

  • GSK Investigational Site

    RECRUITING

    El Paso, Texas, 79902, United States

  • GSK Investigational Site

    RECRUITING

    Houston, Texas, 77098, United States

  • GSK Investigational Site

    RECRUITING

    Salt Lake City, Utah, 84102, United States

  • GSK Investigational Site

    RECRUITING

    Lynchburg, Virginia, 24501, United States

  • GSK Investigational Site

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    Seattle, Washington, 98104, United States

  • GSK Investigational Site

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    Buenos Aires, 1427, Argentina

  • GSK Investigational Site

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    Buenos Aires, C1023AAB, Argentina

  • GSK Investigational Site

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    Buenos Aires, C1425AGC, Argentina

  • GSK Investigational Site

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    Ciudad Autonoma Buenos Aires, C1405CKC, Argentina

  • GSK Investigational Site

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1425AWK, Argentina

  • GSK Investigational Site

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    Córdoba, X5000JJS, Argentina

  • GSK Investigational Site

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    Rosario, 2000, Argentina

  • GSK Investigational Site

    RECRUITING

    San Miguel de Tucumán, T4000IHE, Argentina

  • GSK Investigational Site

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    Darlinghurst, New South Wales, 2010, Australia

  • GSK Investigational Site

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    Sydney, New South Wales, 2010, Australia

  • GSK Investigational Site

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    Taringa, Queensland, 4068, Australia

  • GSK Investigational Site

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    Vancouver, British Columbia, V6Z 2T1, Canada

  • GSK Investigational Site

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    Toronto, Ontario, M5G 1K2, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H2L 4E9, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H2L 4P9, Canada

  • GSK Investigational Site

    RECRUITING

    Aichi, 460-0001, Japan

  • GSK Investigational Site

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    Kanagawa, 221-0855, Japan

  • GSK Investigational Site

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    Osaka, 540-0006, Japan

  • GSK Investigational Site

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    Tokyo, 108-8639, Japan

  • GSK Investigational Site

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    Tokyo, 113-8677, Japan

  • GSK Investigational Site

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    Tokyo, 162-8655, Japan

  • GSK Investigational Site

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    San Pedro Garza García, Nuevo León, 66260, Mexico

  • GSK Investigational Site

    RECRUITING

    Guadajalara, 44280, Mexico

  • GSK Investigational Site

    RECRUITING

    Mexico City, 06760, Mexico

  • GSK Investigational Site

    RECRUITING

    Mexico City, 14080, Mexico

  • GSK Investigational Site

    RECRUITING

    Mérida, 97070, Mexico

  • GSK Investigational Site

    RECRUITING

    San Juan, 00909, Puerto Rico

  • GSK Investigational Site

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    Alicante, 03010, Spain

  • GSK Investigational Site

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    Badalona, 08005, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08026, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08035, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08036, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 8907, Spain

  • GSK Investigational Site

    RECRUITING

    Burgos, 09006, Spain

  • GSK Investigational Site

    RECRUITING

    Cartagena Murcia, 30202, Spain

  • GSK Investigational Site

    RECRUITING

    Córdoba, 14004, Spain

  • GSK Investigational Site

    RECRUITING

    Elche Alicante, 03203, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28007, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28031, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28034, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28040, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28041, Spain

  • GSK Investigational Site

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    Madrid, 28046, Spain

  • GSK Investigational Site

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    Madrid, 28224, Spain

  • GSK Investigational Site

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    Sabadell Barcelona, 08208, Spain

  • GSK Investigational Site

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    Seville, Sevilla, Spain

  • GSK Investigational Site

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    Valencia, 46014, Spain

  • GSK Investigational Site

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    Vigo Pontevedra, 36312, Spain

  • GSK Investigational Site

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    Birmingham, B9 5SS, United Kingdom

  • GSK Investigational Site

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    London, E1 1FR, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, SW10 9NH, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, W2 1NY, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, WC1E 6JB, United Kingdom

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