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Cabotegravir and Rilpivirine Ultra‑Long‑Acting vs Long‑Acting in Adults and Adolescents with HIV Who Are Virally Suppressed

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What is this trial about?

A plain-language summary of the goals, design and what participants do

People living with HIV infections who are already taking antiretroviral therapy (ART) and have a low amount of virus in their blood (called viral suppression) may be offered a new type of treatment that is given as an injection into the muscle. The study uses two medicines, cabotegravir and rilpivirine, formulated so that they are released slowly and stay active in the body for many weeks, allowing dosing only a few times a year.

The purpose of the study is to find out whether the ultra‑long‑acting injection of these two medicines works at least as well as the standard long‑acting version in keeping the virus low and is safe for participants.

Participants will receive an injection at the beginning of the study and then will come back for additional injections at regular intervals over a period of about two years. During the visits, simple blood tests will be done to measure the amount of virus (viral load) and to count immune cells called CD4 cells, which help the body fight infections. The study will also watch for any side effects or reactions to the injections.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial study visit

    You join the study and sign the consent form. during this visit, baseline health information is collected, including blood samples to check your current hiv status and immune cell count.

    You receive the first intramuscular injection of the study medicines. the injection contains cabotegravir (600 mg prolonged‑release suspension) and rilpivirine (dose as specified by the study) which are given into a muscle.

  2. Step 2

    Subsequent injection visits

    You return to the clinic at each scheduled visit for additional intramuscular injections of the same medicines. the schedule is set by the study protocol and continues throughout the trial period.

    Each visit also includes a brief safety check, where any side effects or discomfort are recorded.

  3. Step 3

    Month 11 assessment

    Around month 11, you undergo a detailed assessment. blood is drawn to measure viral load (the amount of hiv‑1 rna in your blood), cd4 cell count (a key immune system indicator), and the levels of the study drugs in your bloodstream.

    The study team also reviews any adverse events you may have experienced and records them.

  4. Step 4

    Month 23 assessment

    At approximately month 23, a second comprehensive assessment is performed. the same laboratory tests as at month 11 are repeated to evaluate the long‑term effectiveness and safety of the medicines.

    Any ongoing or new side effects are documented.

  5. Step 5

    Final study visit

    After the month 23 assessment, you attend a final visit where the study concludes for you. the study team performs a final safety check and may discuss the overall results of your participation.

    No further study medication is given after this visit.

Who can join the trial?

10 criteria

  • Be at least 12 years old and have a diagnosis of HIV‑1 infection.
  • Weigh more than 35 kg (about 77 lb).
  • Show at least two blood test results in the past year where the amount of virus (plasma HIV‑1 RNA) was less than 50 copies per milliliter, with one test done 6‑12 months ago and another within the last 6 months, and have a level below 50 copies/mL at the screening visit.
  • Be taking a daily oral HIV medicine (called an antiretroviral regimen) without interruption for at least the past 6 months.
  • If you have changed your HIV medicines before, the change must have been for reasons such as side‑effects, access, or convenience, not because the virus was not being controlled (a level of HIV‑1 RNA ≥ 200 copies/mL).
  • Not be pregnant or breastfeeding. If you could become pregnant (childbearing potential), you must use a birth‑control method that is considered highly effective (less than 1 % chance of failure) during the study and for one year after the last dose.
  • Have a negative, highly sensitive pregnancy test (urine or blood) at screening and again on the first day of treatment.
  • If a urine pregnancy test is unclear, a blood (serum) test will be done; a positive result means you cannot join the study.
  • Provide written informed consent (and assent if you are a teenager), meaning you understand the study and agree to take part.
  • If you are enrolling in France, you must be part of the French social security system or receive benefits from it.

Who cannot join the trial?

43 criteria

  • Having a significant past or current disease of the heart, lungs, liver, kidneys, digestive system, hormones, blood, or nerves that could change how the study drugs are absorbed, processed, or removed, or that could be risky while taking the medication.
  • Having serious heart problems such as heart failure, noticeable irregular heartbeat, chest pain/ischemia, or a history of heart surgery or procedures.
  • Having uncontrolled cancer; people with controlled cancer may be allowed only after special approval.
  • Being allergic or sensitive to any of the study medicines, their ingredients, or similar drugs.
  • Having any condition that might affect how the drug is absorbed, distributed, metabolized, or excreted, or that makes taking oral or injection medication impossible.
  • Having any physical or mental condition that could prevent following the dosing schedule, attending study visits, or that could endanger your safety.
  • Having a liver enzyme called ALT that is three times or more above the normal upper limit (ULN).
  • Having a total bilirubin level more than 1.5 times the normal upper limit, unless you have Gilbert’s syndrome and your direct bilirubin is 1.5 times the limit or less.
  • Having cirrhosis or unstable liver or bile‑duct disease, such as fluid buildup in the abdomen, confusion, bleeding problems, low blood protein, enlarged veins in the esophagus or stomach, or persistent yellowing of the skin.
  • Having a corrected heart‑rate QT interval (QTcF) longer than 450 milliseconds.
  • Taking any other medication that can cause a dangerous heart rhythm called Torsades de Pointes.
  • Being pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
  • Having previously taken the study drugs cabotegravir (CAB) or rilpivirine (RPV) for HIV treatment or prevention.
  • Receiving an HIV‑1 immunotherapy vaccine within the past 90 days, or any long‑acting HIV therapy such as lenacapavir or broadly neutralizing antibodies.
  • Needing chronic blood‑thinning medication, except low‑dose aspirin (≤325 mg).
  • Having undergone radiation therapy within 28 days before screening.
  • Having received chemotherapy (cancer‑killing drugs) within 28 days before screening.
  • Having taken tuberculosis treatment within 28 days before screening, except the drug isoniazid.
  • Having taken blood‑thinning medication within 28 days before screening, except low‑dose aspirin.
  • Using strong immune‑modifying drugs (such as systemic steroids, interleukins, or interferons) within 28 days, except short‑term steroids (≤21 days) or topical/inhaled steroids.
  • Having taken an experimental drug or vaccine within the required wash‑out period (28 days, five drug half‑lives, or twice the biological effect duration, whichever is longer) before the first dose.
  • Taking any medication that the study protocol prohibits and being unwilling or unable to switch to an allowed alternative.
  • Having an active AIDS‑defining illness (CDC Stage 3) except skin Kaposi’s sarcoma that does not require systemic therapy.
  • Being currently enrolled in or having participated in another clinical study with an investigational product within the last 90 days.
  • Already being enrolled in this same study.
  • Having a recent HIV‑1 viral load of 50 copies/mL or higher within the past 6 months.
  • Having a viral load of 200 copies/mL or higher, or two or more measurements of 50 copies/mL or higher, within 6‑12 months before screening.
  • Any acute laboratory abnormality at screening that the investigator believes would make participation unsafe.
  • Any confirmed Grade 4 laboratory abnormality (very severe), except very high triglycerides, lipids, or creatine phosphokinase (CPK); a repeat test may be allowed.
  • Kidney function measured as eGFR less than 30 mL/min/1.73 m² for adults or less than 50 mL/min/1.73 m² for adolescents.
  • Having hemoglobin (a measure of red blood cells) less than 9.0 g/dL.
  • Having an absolute neutrophil count (ANC, a type of white blood cell) less than 600 per mm³.
  • Having major resistance mutations to the drug classes used in the study (INSTI or NNRTI) based on prior resistance testing.
  • Having unstable liver disease (fluid in the abdomen, confusion, bleeding problems, low blood protein, enlarged veins, or persistent jaundice) or known bile‑duct problems, except stable conditions like Gilbert’s syndrome, asymptomatic gallstones, or chronic stable liver disease.
  • Being unwilling or unable to receive injections in the buttock (gluteal) muscle.
  • Having buttock implants, prostheses, tattoos, or skin conditions over the injection site that could affect evaluation of the injection.
  • Being an adolescent who is a ward of the state or government.
  • Being a study staff participant who does not agree to be audio‑recorded during interviews (only applies to staff selected for interviews).
  • Testing positive for hepatitis B surface antigen (HBsAg), which indicates active hepatitis B infection.
  • Testing negative for hepatitis B surface antibody (HBsAb) and surface antigen (HBsAg) but positive for core antibody (HBcAb) may lead to exclusion if hepatitis B DNA is detected; if DNA is not detected, participation may be allowed.
  • Having a history of liver cirrhosis with or without hepatitis viral co‑infection.
  • Being at high risk for seizures or having an uncontrolled seizure disorder; a prior seizure may be considered only after careful review.
  • Having a significant risk of suicide, including past suicidal thoughts or behaviors, as judged by the investigator.
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Investigated drugs

  • Rilpivirine prolonged‑release injection (REKAMBYS)

    is a medication that contains the antiretroviral drug rilpivirine. It is formulated as a suspension that is injected into the muscle and slowly releases the drug over many weeks. In this trial it is used as a comparator to show how well a long‑acting rilpivirine injection can keep the virus under control in people who are already virologically suppressed.

  • Rilpivirine prolonged‑release injection (JNJ‑16150108)

    is another formulation of the same antiretroviral drug rilpivirine, but it is identified by its study code JNJ‑16150108. Like the REKAMBYS product, it is given as a muscle injection that releases the drug gradually. This version is tested as the experimental (test) product to compare its effectiveness and safety with the comparator formulation.

  • Cabotegravir powder for suspension injection (CABOTEGRAVIR)

    contains the antiretroviral drug cabotegravir. The powder is mixed with liquid to create a suspension that is injected into the muscle, where it forms a depot that releases cabotegravir slowly over several months. In the study it serves as the test medication, paired with the experimental rilpivirine injection, to evaluate a new ultra‑long‑acting treatment option.

  • Cabotegravir prolonged‑release injection (Vocabria)

    is a marketed long‑acting form of cabotegravir that is also injected into the muscle as a suspension. It provides steady drug levels for many weeks and is used in the trial as the comparator to see how the new ultra‑long‑acting cabotegravir formulation compares in keeping the virus suppressed.

What is already known about the treatment

  • REKAMBYS 900 mg prolonged‑release suspension for injection

    This product is a prolonged‑release suspension that is given by a single intramuscular injection. Rilpivirine, the active ingredient, is an approved medicine used worldwide for the treatment of HIV‑1 infection in adults and adolescents who are already virologically suppressed. It works by attaching to the viral reverse‑transcriptase enzyme, preventing the virus from copying its genetic material. Pharmacologically it is classified as a non‑nucleoside reverse transcriptase inhibitor (NNRTI).

  • CABOTEGRAVIR

    Cabotegravir is supplied as a powder that is mixed with liquid to form a suspension, which is then injected into a muscle. It is an approved long‑acting drug for HIV‑1 treatment and is being studied in many clinical trials as a maintenance therapy. The drug blocks the HIV integrase enzyme, stopping the virus from inserting its DNA into the host cell’s genome. It belongs to the class of integrase strand transfer inhibitors (INSTIs).

  • JNJ‑16150108

    This medication is a prolonged‑release suspension administered by intramuscular injection. It contains rilpivirine, a drug that is already approved for use in HIV‑1 infected patients who have achieved viral suppression. Rilpivirine prevents the virus from making new copies of its RNA by inhibiting the reverse‑transcriptase enzyme. It is classified as a non‑nucleoside reverse transcriptase inhibitor.

  • Vocabria 600 mg prolonged‑release suspension for injection

    Vocabria is a prolonged‑release suspension that is injected into a muscle after reconstitution. The active substance, cabotegravir, is an approved long‑acting treatment for HIV‑1 infection in adults and adolescents who are virologically suppressed. It stops HIV from integrating its DNA into the host cell by blocking the integrase enzyme. Cabotegravir is categorized as an integrase strand transfer inhibitor.

Investigated diseases

HIV infection - HIV is a virus that attacks the immune system, weakening the body's ability to fight infections. It often begins with a brief flu‑like illness and then can remain silent for years while the virus continues to multiply. Over time the loss of immune cells makes common infections and certain cancers appear more easily. The disease can progress from this silent stage to a more advanced stage where the immune system is severely damaged. This progression is tracked by the amount of virus in the blood and the count of CD4 cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518511-19-00Protocol code222794Estimated enrolment564 patientsSponsorViiv Healthcare UK Limited

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