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HIV InfectionsPhase 3CROWNNCT06694805

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

A Phase 3 study testing CAB LA + RPV LA and Oral ART in people with HIV Infections, run by ViiV Healthcare at 85 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
HIV Infections
What is being tested?
CAB LA + RPV LA and Oral ART
Could I receive a placebo?
No, everyone receives an active treatment
How many people
326 participants
Where
85 sitesin 8 countries
Study dates
2 Dec 2024to 9 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age
  • 1. Aged >=12 years and >=35 kg (at the time of obtaining informed consent).
  • Type of Participant and Disease Characteristics 2.HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL.
  • 3.Plasma HIV-1 RNA >1 000 c/mL and greater than (<) 100 000 c/mL at Screening. 4.Evidence of insufficient virologic response to participant's current oral ART regimen within 18 months prior to study entry according to at least 1 of the following criteria: i.<1 log10 decrease in HIV-1 RNA or HIV-1 RNA >200 c/mL at 2 time points at least 4 weeks apart in individuals who have been prescribed oral ART for at least 3 consecutive months.
  • Documented lapse in current oral ART regimen usage expected to result in HIV-1 viremia (defined as at least a 30-day consecutive period of non-use of oral ART) iii. Documented need for change from oral ART regimen that investigator attributes as primary reason for insufficient virologic response (e.g., safety findings and/or limited tolerability, clinically relevant DDIs).
  • Currently being treated with an oral ART regimen specific regimen to be recorded at Screening, and willing to continue taking that regimen until approximately 1 week after the Month 6 visit.
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  • Pregnancy, Sex and Contraceptive/Barrier Requirements 5. Person of childbearing potential (POCBP) must have a negative serum or urine pregnancy test at screening and on Day 1.
  • Informed Consent/Assent 6.Informed consent/Assent must be provided as follows:
  • Adult participants (>=18 years old) must be capable of giving signed informed consent as described in the full study protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and stated in the full study protocol.
  • For adolescent participants (12 to <18 years of age at screening), the parent(s) or legal guardian must be capable of giving signed informed consent.

Who cannot join

  • Medical Conditions
  • HIV-1 Subtype A6, if known from historical result.
  • Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study.
  • Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones).
  • Individuals with both HIV and Hepatitis B virus (HBV) will be excluded from participating in studies where they would not be able to receive appropriate therapy for their HBV co-infection and therefore may be at risk of hepatitis B flare. Exclusion will be determined by evidence of HBV infection based on the results of testing at Screening for HBsAg, HBcAb, HBsAb and HBV.
  • History of liver cirrhosis with or without hepatitis viral co-infection.
Show all 40Show fewer
  • Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
  • Participants with HCV co-infection will be excluded entry into this study if they are currently receiving anti-HCV therapy at baseline (Day 1).
  • Participants determined by the investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder.
  • 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 Medical Monitor, contraindicates their participation.
  • Participants who in the investigator's judgment, pose a significant suicidality risk. Participant's history of suicidal behaviour and/or suicidal ideation should be considered when evaluating for suicide risk.
  • Any pre-existing physical or mental condition 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.
  • Prior/Concomitant Therapy
  • Any previous use of CAB.
  • Current or anticipated need for chronic anti-coagulants.
  • Use of concomitant medications which are associated with Torsades de Pointes (TdP).
  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
  • Treatment with any of the following agents within 28 days of Screening:
  • radiation therapy;
  • cytotoxic chemotherapeutic agents;
  • tuberculosis therapy with the exception of isoniazid;
  • anti-coagulation agents, with the exception of the use of low dose acetylsalicylic acid (<=325mg);
  • immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons.
  • Exposure to an experimental drug or experimental vaccine within either 28 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 the first dose of investigational medicinal product (IP).
  • Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
  • Prior/Concurrent Clinical Study Experience
  • Participant is currently participating in, or anticipates being selected for, any other interventional study.
  • Diagnostic assessments
  • Any evidence of viral drug resistance based on the presence of any major RAM to INSTIs or NNRTIs in the Screening result; or, if known, in any historical resistance test result.
  • Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
  • Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. A single repeat test is allowed during the Screening period to verify a result.
  • ALT >=5 times ULN or ALT >=3×ULN and bilirubin >=1.5×ULN (with >35% direct bilirubin).
  • eGFR of <30 mL/min/1.73 m2 via refitted, race-neutral CKD-EPIcr_R method (adult participants) or <50 mL/min/1.73 m2 using the Bedside Schwartz equation (adolescent participants).
  • Hemoglobin <9.0 g/dL.
  • Corrected QT interval (QTc >450 msec or QTc >480 msec for participants with bundle branch block, calculated using ECGs performed in triplicate).
  • Other exclusions
  • Unwilling to receive injections, or unable to receive gluteal injections.
  • The participant has gluteal implants or prosthesis; or a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reaction (ISRs).
  • Evidence of alcohol or substance use disorder within the previous 12 months, using standard methods for their site, that would interfere with the participant's safety.
  • Adolescents who are wards of the state or government. To assess any potential impact on participant eligibility with regard to safety, the investigator must refer to the Investigator's brochure (IB) and supplements, approved product labels, and/or local prescribing information for detailed information regarding warnings, precautions, contraindications, AEs, drug interactions, and other significant data pertaining to the study drugs.

Trial locations and contacts

85 sites in 8 countries.

85 sites in 8 countries

United States39 sites

  • GSK Investigational Site

    Atlanta, Georgia, 30308

  • GSK Investigational Site

    Aurora, Colorado, 80045

  • GSK Investigational Site

    Baltimore, Maryland, 21201

  • GSK Investigational Site

    Baltimore, Maryland, 21287

  • GSK Investigational Site

    Berkley, Michigan, 48072

  • GSK Investigational Site

    Birmingham, Alabama, 35222

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Chicago, Illinois, 60611-2826

  • GSK Investigational Site

    Chicago, Illinois, 60613

  • GSK Investigational Site

    Chicago, Illinois, 60637

  • GSK Investigational Site

    Cincinnati, Ohio, 45267

  • GSK Investigational Site

    Columbus, Ohio, 43210

  • GSK Investigational Site

    Dallas, Texas, 75246-2004

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Denver, Colorado, 80204

  • GSK Investigational Site

    Greensboro, North Carolina, 27401-1209

  • GSK Investigational Site

    Hawthorne, New York, 10532-2140

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Jacksonville, Florida, 32209

  • GSK Investigational Site

    Kansas City, Missouri, 64111

  • GSK Investigational Site

    Los Angeles, California, 90035

  • GSK Investigational Site

    Los Angeles, California, 90036

  • GSK Investigational Site

    Los Angeles, California, 90069

  • GSK Investigational Site

    Macon, Georgia, 31201

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53212

  • GSK Investigational Site

    New Haven, Connecticut, 06510

  • GSK Investigational Site

    New York, New York, 10010

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    Newark, Delaware, 19711

  • GSK Investigational Site

    Newark, New Jersey, 07102

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Sarasota, Florida, 34237-3116

  • GSK Investigational Site

    Seattle, Washington, 98104-2420

  • GSK Investigational Site

    St Louis, Missouri, 63110-1035

  • GSK Investigational Site

    The Bronx, New York, 10467

  • GSK Investigational Site

    The Bronx, New York, 10468-3904

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20017

  • GSK Investigational Site

    West Palm Beach, Florida, 33409

Other trials in United States

Spain24 sites

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08026

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Bilbao, Bizkaia, 48013

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28020

  • GSK Investigational Site

    Madrid, 28031

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Málaga, 29530

  • GSK Investigational Site

    Murcia, 30120

  • GSK Investigational Site

    Palma de Mallorca, 07120

  • GSK Investigational Site

    Puerto Real, Cádiz, 11510

  • GSK Investigational Site

    Sabadell Barcelona, 08208

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Vigo Pontevedra, 36312

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

Argentina7 sites

  • GSK Investigational Site

    Buenos Aires, 1023

  • GSK Investigational Site

    Buenos Aires, 1427

  • GSK Investigational Site

    Buenos Aires, C1425AGC

  • GSK Investigational Site

    Capital Federal, C1181ACH

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, C1405CKC

  • GSK Investigational Site

    Córdoba, X5000JJS

  • GSK Investigational Site

    Rosario, S2000PBJ

Other trials in Argentina

Germany5 sites

  • GSK Investigational Site

    Berlin, 10439

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50674

  • GSK Investigational Site

    Cologne, 50668

  • GSK Investigational Site

    Düsseldorf, North Rhine-Westphalia, 40225

  • GSK Investigational Site

    Frankfurt, 60596

Other trials in Germany

Italy5 sites

  • GSK Investigational Site

    Bari

  • GSK Investigational Site

    Bergamo, 24127

  • GSK Investigational Site

    Milan, 20127

  • GSK Investigational Site

    Milan, 20142

  • GSK Investigational Site

    Roma, 00149

Other trials in Italy

Canada2 sites

  • GSK Investigational Site

    Montreal, Quebec, H2L 4P9

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1

Other trials in Canada

Portugal2 sites

  • GSK Investigational Site

    Porto, 4099-001

  • GSK Investigational Site

    Porto, 4200-319

Other trials in Portugal

Belgium1 site

  • GSK Investigational Site

    Antwerp, 2000

Other trials in Belgium

About this study

Official title: A Phase 3b, Open Label, Randomized, standard-of Care Control Arm, Multicenter, Superiority Study Evaluating the Efficacy, Safety, and Tolerability of Injectable CAB LA + RPV LA in Viremic Participants Living With HIV-1 (CROWN)

This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.

Conditions
HIV Infections
Being tested
CAB LA + RPV LA, Oral ART
Keywords
HIV Infection, Cabotegravir, Rilpivirine, Long-acting, Efficacy, Safety, Durability
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAB LA + RPV LADrug

    Intramuscular injection administered monthly for first 2 initiation doses then every 2 months.

  • Oral ARTDrug

    Oral medication provided to participants by the site/their regular healthcare professional (HCP) as part of their standard of care (SOC) treatment.

Study groups in NCT06694805
Study groupRoleWhat they receive
CAB LA + RPV LA GroupExperimentalParticipants receive initial injections at Day 1 and Month 1, followed by maintenance injections every 2 months for up to 24 months.
Receives: Drug: CAB LA + RPV LA
Oral ART Control GroupActive comparatorParticipants continue to take their current oral ART for 6 months, including a final dose at their first injection visit.
Receives: Drug: Oral ART

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with virologic suppression after the CAB LA + RPV LA treatment compared to oral ART

    A virologic suppression is defined by HIV-1 RNA less than (<) 50 copies (c)/mL.

    Measured: At Month 6

Secondary outcomes (9)

  1. Time to virologic suppression

    Measured: From Baseline (Day 1) up to Month 6

  2. Time to treatment related discontinuation (=Failure) (TRDF)

    TRDF can be caused by a confirmed virologic failure or a drug-related adverse event (AE), intolerability of injections, protocol defined stopping criteria or lack of efficacy.

    Measured: From Baseline (Day 1) up to Month 6

  3. Number of participants with confirmed protocol-defined virologic failure (VF)

    VF is defined as: confirmed plasma HIV-1 RNA levels greater than or equal to (>=) 400 c/mL on or after Month 4; confirmed rebound in plasma HIV-1 RNA levels to >=400 c/mL after prior confirmed suppression to <400 c/mL; confirmed plasma HIV-1 RNA levels greater than (>) 1 log10 c/mL above the nadir value where nadir is >=400 c/mL; decrease in plasma HIV-1 RNA of <1 log10 c/mL by Month 1, with subsequent. confirmation, and resistance emergence to ARVs (unless plasma HIV-1 RNA is. <400 c/mL).

    Measured: From Baseline (Day 1) up to Month 6

  4. Number of participants with treatment-emergent resistance-associated mutations (RAMs)

    Measured: From Baseline (Day 1) up to Month 6

  5. Number of participants with treatment-emergent RAMs

    Measured: Up to Month 12 and Month 24

  6. Number of participants with serious adverse events (SAEs)

    A SAE is defined as any untoward medical occurrence that, at any dose, meets one or. more of the following criteria: results in death, is life threatening, requires inpatient hospitalization (or prolongation of existing hospitalization), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes and other significant medical events deemed so by the investigator.

    Measured: Up to Month 6, Month 12, and Month 24

  7. Number of deaths

    Measured: Up to Month 6, Month 12, and Month 24

  8. Number of participants with Grade 2 to 5 drug-related adverse events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not. considered related to the study intervention. Every AE is graded according to the DAIDS toxicity scales. Grade 2 = moderate symptoms, Grade 3 = severe symptoms, Grade 4 = Potentially life-threatening. symptoms and Grade 5 = death.

    Measured: Up to Month 6, Month 12, and Month 24

  9. Number of AEs leading to discontinuation

    Measured: Up to Month 6, Month 12, and Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2024
  2. Study start2 Dec 2024
  3. Primary completion19 Aug 2026
  4. Study completion9 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
326 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06694805
Sponsor's protocol ID
221611
Other IDs
2024-515070-28-00
Acronym
CROWN
Status last verified
Sep 2026
First submitted
15 Nov 2024
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Study 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CAB LA + RPV LA and Oral ART in people with HIV Infections, run by ViiV Healthcare at 85 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Spain, Argentina, Germany, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with virologic suppression after the CAB LA + RPV LA treatment compared to oral ART (time frame: At Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06694805.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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