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New HIV study offers patients a choice: daily pill or bimonthly shot

NCT ID NCT05917509

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looked at two ways to control HIV in 171 adults who had never been treated before. Everyone started with a daily pill (dolutegravir/lamivudine). Once the virus was undetectable, participants could choose to switch to a shot (cabotegravir plus rilpivirine) given every two months or stay on the pill. The goal was to see how well each option kept the virus suppressed and how patients felt about their treatment.

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

171 people

The number who actually took part.

Started

Jul 2023

Finished

Apr 2026

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. Participants with plasma HIV-1 RNA ≥1,000 c/mL at Screening. 2. Antiretroviral-naïve participants (defined as no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) prior to enrolment. 3. Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. 4. Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category. Exclusion Criteria: 1. Women who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study. 2. Participants with any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease; with the exception of cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ count \<200 cells/cubic millimetre (mm\^3) (neither is exclusionary). 3. Participants with 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, in the opinion of the Investigator or Medical Monitor, contraindicates study participation. 4. Participants with ongoing or clinically relevant pancreatitis. 5. Participants with Clinically significant cardiovascular disease, as defined by recent history (within the last 6 months) or current evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease. 6. Corrected QT (QTc) interval \>450 milliseconds (msec) (or QTc \>480 msec for participants with bundle branch block). 7. Participants with ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the Investigator and the Medical Monitor for inclusion of the participant prior to enrolment. 8. Participants with hereditary coagulation and platelet disorders (e.g., haemophilia or von Willebrand Disease); or current or anticipated need for chronic anti-coagulation, with the exception of the use of low-dose acetylsalicylic acid (≤325 mg). 9. Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification. 10. Participants with unstable liver disease as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis, or decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per Investigator assessment). 11. Participants with history of liver cirrhosis with or without hepatitis viral co-infection. 12. Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrolment. 13. Participants who, in the Investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. 14. Participants with signs and symptoms which, in the opinion of the Investigator, are suggestive of active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days prior to enrolment. 15. Evidence of hepatitis B virus (HBV) infection based on the results of testing at Screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), and hepatitis B surface antibody (anti-HBs) as follows: * Participants positive for HBsAg are excluded * Participants negative for HBsAg and negative for anti-HBs but positive for anti-HBc are excluded only if HBV DNA is detected \[either detected below lower limit of quantification (LLOQ); detected above upper limit of quantification (ULOQ); or numerical value (i.e. between LLOQ and ULOQ)\]; * Participants negative for HBsAg but positive for anti-HBc and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. 16. Participants with hepatitis C virus (HCV) co-infection at Screening are eligible only if: * liver enzymes meet entry criteria; and * HCV disease is not anticipated to require on-study treatment with any agent(s) that have potential adverse drug-drug interactions (DDIs) with the study interventions; and * HCV disease has undergone appropriate work-up and is not advanced or associated with cirrhosis 17. Participants with untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of completed treatment at least 7 days prior to enrolment) are excluded. Participants with a false positive RPR (with negative treponemal test) or serofast RPR result (persistence of a reactive nontreponemal syphilis test despite history of adequate therapy and no evidence of re-exposure) may enroll after consultation with the Medical Monitor. Participants who completed treatment at least 7 days prior to enrolment are eligible. 18. Known or suspected presence of any major resistance mutations as defined by the international AIDS society (IAS)-United States of America (USA) resistance guidelines to DTG, 3TC, CAB or RPV in any resistance test result. 19. Participants with exposure to 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 first dose of study treatment. 20. Participants with treatment with any of the following agents within 28 days of Screening: * radiation therapy * cytotoxic chemotherapeutic agents; * tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid, INH); * anti-coagulation agents, with the exception of the use of low dose acetylsalicylic acid (≤325 mg); * immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. Note: Participants using short-term (e.g. ≤21 days) systemic corticosteroid treatment; topical, inhaled and intranasal corticosteroids are eligible for enrolment 21. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. 22. Treatment with any agent with documented activity against HIV-1 in vitro within 28 days of first dose of study treatment. Treatment with acyclovir/valacyclovir is permitted. 23. Use of medications which are associated with Torsade de Pointes 24. Participants receiving any protocol-defined prohibited medication and who are unwilling or unable to switch to an alternate medication. 25. Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. 26. Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the participant's participation in an interventional clinical trial. 27. Participant has estimated creatine clearance \<30 milliliter per minute (mL/min) per 1.73 square meter (m\^2) using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration (CKDEPIcr\_R) method. 28. Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN); or ALT ≥3xULN and bilirubin ≥1.5xULN (with \>35 percentage (%) direct bilirubin). 29. Participants known or suspected to have acquired HIV-1 concurrent with use of protease-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) must be discussed with the Medical Monitor prior to enrolment. 30. Participant has a gluteal implant/enhancements (including fillers); or tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions. 31. Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study drugs. 32. Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, 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. 33. Participant is currently participating in, or anticipates being selected for, any other interventional study.

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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

Contacts and locations

Locations

  • GSK Investigational Site

    Birmingham, Alabama, 35205, United States

  • GSK Investigational Site

    Bakersfield, California, 93301, United States

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33308, United States

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982, United States

  • GSK Investigational Site

    Orlando, Florida, 32804, United States

  • GSK Investigational Site

    Pensacola, Florida, 32504, United States

  • GSK Investigational Site

    Berkley, Michigan, 48072, United States

  • GSK Investigational Site

    Kansas City, Missouri, 64111, United States

  • GSK Investigational Site

    Omaha, Nebraska, 68198, United States

  • GSK Investigational Site

    Henderson, Nevada, 89106, United States

  • GSK Investigational Site

    Charlotte, North Carolina, 28204, United States

  • GSK Investigational Site

    Huntersville, North Carolina, 28078, United States

  • GSK Investigational Site

    Beaumont, Texas, 77701, United States

  • GSK Investigational Site

    Dallas, Texas, 75246, United States

  • GSK Investigational Site

    Fort Worth, Texas, 76104, United States

  • GSK Investigational Site

    Buenos Aires, C1202, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, 1405, Argentina

  • GSK Investigational Site

    Mar del Plata, B7600DHK, Argentina

  • GSK Investigational Site

    Rosario, S2013, Argentina

  • GSK Investigational Site

    Hamilton, Ontario, L8S 1A4, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2L 4P9, Canada

  • GSK Investigational Site

    La Cisterna, 7970000, Chile

  • GSK Investigational Site

    Providencia, 7500000, Chile

  • GSK Investigational Site

    Santiago, 9500000, Chile

  • GSK Investigational Site

    Temuco, 4780000, Chile

  • GSK Investigational Site

    Créteil, 94000, France

  • GSK Investigational Site

    Orléans, 45067, France

  • GSK Investigational Site

    Paris, 75004, France

  • GSK Investigational Site

    Paris, 75015, France

  • GSK Investigational Site

    Paris, 75475, France

  • GSK Investigational Site

    Düsseldorf, 40225, Germany

  • GSK Investigational Site

    Frankfurt am Main, 60329, Germany

  • GSK Investigational Site

    Hamburg, 20246, Germany

  • GSK Investigational Site

    München, 80337, Germany

  • GSK Investigational Site

    Foggia, 71100, Italy

  • GSK Investigational Site

    Milan, 20127, Italy

  • GSK Investigational Site

    Milan, 20157, Italy

  • GSK Investigational Site

    Roma, 00149, Italy

  • GSK Investigational Site

    Ponce, 00717-1563, Puerto Rico

  • GSK Investigational Site

    Almería, 04009, Spain

  • GSK Investigational Site

    Granada, 35016, Spain

  • GSK Investigational Site

    La Laguna-Tenerife, 35010, Spain

  • GSK Investigational Site

    Madrid, 28007, Spain

  • GSK Investigational Site

    Madrid, 28031, Spain

  • GSK Investigational Site

    Málaga, 29010, Spain

  • GSK Investigational Site

    Murcia, 30008, Spain

  • GSK Investigational Site

    Seville, 41071, Spain

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