Badanie oceniające skuteczność długo działającego (LA) kabotegrawiru (CAB) + rylpiwiryny (RPV) LA podawanego uczestnikom z wykrywalnym wirusem HIV-1 (CROWN)
A Faza 3b, otwarte, randomizowane, ramię kontrolne o standardowej opiece, wieloośrodkowe, badanie wyższości oceniające skuteczność, bezpieczeństwo i tolerancję wstrzykiwanego CAB LA + RPV LA u uczestników z wiremią żyjących z HIV-1 (KORONA)
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Buenos Aires, Argentyna, 1023
- GSK Investigational Site
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Buenos Aires, Argentyna, C1425AGC
- GSK Investigational Site
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Buenos Aires, Argentyna, 1427
- GSK Investigational Site
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Capital Federal, Argentyna, C1181ACH
- GSK Investigational Site
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Ciudad Autonoma Buenos Aires, Argentyna, C1405CKC
- GSK Investigational Site
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Córdoba, Argentyna, X5000JJS
- GSK Investigational Site
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Rosario, Argentyna, S2000PBJ
- GSK Investigational Site
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Antwerp, Belgia, 2000
- GSK Investigational Site
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Barcelona, Hiszpania, 08036
- GSK Investigational Site
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Barcelona, Hiszpania, 08035
- GSK Investigational Site
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Barcelona, Hiszpania, 08003
- GSK Investigational Site
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Barcelona, Hiszpania, 08026
- GSK Investigational Site
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Córdoba, Hiszpania, 14004
- GSK Investigational Site
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Madrid, Hiszpania, 28041
- GSK Investigational Site
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Madrid, Hiszpania, 28006
- GSK Investigational Site
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Madrid, Hiszpania, 28007
- GSK Investigational Site
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Madrid, Hiszpania, 28040
- GSK Investigational Site
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Madrid, Hiszpania, 28046
- GSK Investigational Site
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Madrid, Hiszpania, 28034
- GSK Investigational Site
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Madrid, Hiszpania, 28031
- GSK Investigational Site
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Madrid, Hiszpania, 28020
- GSK Investigational Site
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Murcia, Hiszpania, 30120
- GSK Investigational Site
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Málaga, Hiszpania, 29010
- GSK Investigational Site
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Málaga, Hiszpania, 29530
- GSK Investigational Site
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Palma de Mallorca, Hiszpania, 07120
- GSK Investigational Site
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Sabadell Barcelona, Hiszpania, 08208
- GSK Investigational Site
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Seville, Hiszpania, 41013
- GSK Investigational Site
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Vigo Pontevedra, Hiszpania, 36312
- GSK Investigational Site
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Zaragoza, Hiszpania, 50009
- GSK Investigational Site
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Hiszpania, 08907
- GSK Investigational Site
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Bizkaia
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Bilbao, Bizkaia, Hiszpania, 48013
- GSK Investigational Site
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Cádiz
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Puerto Real, Cádiz, Hiszpania, 11510
- GSK Investigational Site
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Quebec
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Montreal, Quebec, Kanada, H2L 4P9
- GSK Investigational Site
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Montreal, Quebec, Kanada, H4A 3J1
- GSK Investigational Site
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Berlin, Niemcy, 10439
- GSK Investigational Site
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Cologne, Niemcy, 50668
- GSK Investigational Site
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Frankfurt, Niemcy, 60596
- GSK Investigational Site
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North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, Niemcy, 50674
- GSK Investigational Site
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Düsseldorf, North Rhine-Westphalia, Niemcy, 40225
- GSK Investigational Site
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Porto, Portugalia, 4099-001
- GSK Investigational Site
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Porto, Portugalia, 4200-319
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35222
- GSK Investigational Site
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California
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Los Angeles, California, Stany Zjednoczone, 90069
- GSK Investigational Site
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Los Angeles, California, Stany Zjednoczone, 90036
- GSK Investigational Site
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Los Angeles, California, Stany Zjednoczone, 90035
- GSK Investigational Site
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80045
- GSK Investigational Site
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Denver, Colorado, Stany Zjednoczone, 80204
- GSK Investigational Site
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Connecticut
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New Haven, Connecticut, Stany Zjednoczone, 06510
- GSK Investigational Site
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Delaware
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Newark, Delaware, Stany Zjednoczone, 19711
- GSK Investigational Site
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District of Columbia
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Washington D.C., District of Columbia, Stany Zjednoczone, 20017
- GSK Investigational Site
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Florida
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Jacksonville, Florida, Stany Zjednoczone, 32209
- GSK Investigational Site
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Miami, Florida, Stany Zjednoczone, 33136
- GSK Investigational Site
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Sarasota, Florida, Stany Zjednoczone, 34237-3116
- GSK Investigational Site
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West Palm Beach, Florida, Stany Zjednoczone, 33409
- GSK Investigational Site
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30308
- GSK Investigational Site
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Decatur, Georgia, Stany Zjednoczone, 30033
- GSK Investigational Site
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Macon, Georgia, Stany Zjednoczone, 31201
- GSK Investigational Site
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60637
- GSK Investigational Site
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Chicago, Illinois, Stany Zjednoczone, 60613
- GSK Investigational Site
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Chicago, Illinois, Stany Zjednoczone, 60611-2826
- GSK Investigational Site
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21201
- GSK Investigational Site
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Baltimore, Maryland, Stany Zjednoczone, 21287
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02115
- GSK Investigational Site
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Michigan
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Berkley, Michigan, Stany Zjednoczone, 48072
- GSK Investigational Site
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Missouri
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Kansas City, Missouri, Stany Zjednoczone, 64111
- GSK Investigational Site
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St Louis, Missouri, Stany Zjednoczone, 63110-1035
- GSK Investigational Site
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New Jersey
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Newark, New Jersey, Stany Zjednoczone, 07102
- GSK Investigational Site
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New York
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Hawthorne, New York, Stany Zjednoczone, 10532-2140
- GSK Investigational Site
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New York, New York, Stany Zjednoczone, 10032
- GSK Investigational Site
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New York, New York, Stany Zjednoczone, 10010
- GSK Investigational Site
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The Bronx, New York, Stany Zjednoczone, 10467
- GSK Investigational Site
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The Bronx, New York, Stany Zjednoczone, 10468-3904
- GSK Investigational Site
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North Carolina
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Greensboro, North Carolina, Stany Zjednoczone, 27401-1209
- GSK Investigational Site
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Ohio
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Cincinnati, Ohio, Stany Zjednoczone, 45267
- GSK Investigational Site
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Columbus, Ohio, Stany Zjednoczone, 43210
- GSK Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- GSK Investigational Site
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Texas
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Dallas, Texas, Stany Zjednoczone, 75246-2004
- GSK Investigational Site
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Houston, Texas, Stany Zjednoczone, 77030
- GSK Investigational Site
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Washington
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Seattle, Washington, Stany Zjednoczone, 98104-2420
- GSK Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, Stany Zjednoczone, 53212
- GSK Investigational Site
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Bari, Włochy
- GSK Investigational Site
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Bergamo, Włochy, 24127
- GSK Investigational Site
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Milan, Włochy, 20142
- GSK Investigational Site
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Milan, Włochy, 20127
- GSK Investigational Site
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Roma, Włochy, 00149
- GSK Investigational Site
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
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Age
1. Aged >=12 years and >=35 kg (at the time of obtaining informed consent).
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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.
ii. 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.
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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.
Exclusion Criteria:
• Medical Conditions
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HIV-1 Subtype A6, if known from historical result.
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Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study.
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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).
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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.
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History of liver cirrhosis with or without hepatitis viral co-infection.
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Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
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Participants with HCV co-infection will be excluded entry into this study if they are currently receiving anti-HCV therapy at baseline (Day 1).
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Participants determined by the investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder.
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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.
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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.
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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
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Any previous use of CAB.
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Current or anticipated need for chronic anti-coagulants.
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Use of concomitant medications which are associated with Torsades de Pointes (TdP).
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Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
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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.
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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).
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Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
• Prior/Concurrent Clinical Study Experience
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Participant is currently participating in, or anticipates being selected for, any other interventional study.
• Diagnostic assessments
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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.
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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.
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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.
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ALT >=5 times ULN or ALT >=3×ULN and bilirubin >=1.5×ULN (with >35% direct bilirubin).
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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).
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Hemoglobin <9.0 g/dL.
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Corrected QT interval (QTc >450 msec or QTc >480 msec for participants with bundle branch block, calculated using ECGs performed in triplicate).
• Other exclusions
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Unwilling to receive injections, or unable to receive gluteal injections.
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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).
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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.
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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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: CAB LA + RPV LA Group
Participants receive initial injections at Day 1 and Month 1, followed by maintenance injections every 2 months for up to 24 months. |
Intramuscular injection administered monthly for first 2 initiation doses then every 2 months. |
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Aktywny komparator: Oral ART Control Group
Participants continue to take their current oral ART for 6 months, including a final dose at their first injection visit. |
Oral medication provided to participants by the site/their regular healthcare professional (HCP) as part of their standard of care (SOC) treatment. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of participants with virologic suppression after the CAB LA + RPV LA treatment compared to oral ART
Ramy czasowe: At Month 6
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A virologic suppression is defined by HIV-1 RNA less than (<) 50 copies (c)/mL. |
At Month 6
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Czas na supresję wirusologiczną
Ramy czasowe: Od wartości początkowej (dzień 1) do miesiąca 6
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Od wartości początkowej (dzień 1) do miesiąca 6
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Liczba uczestników z mutacjami związanymi z opornością (RAM) powstałymi podczas leczenia
Ramy czasowe: Od wartości początkowej (dzień 1) do miesiąca 6
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Od wartości początkowej (dzień 1) do miesiąca 6
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Liczba uczestników z pamięcią RAM pojawiającą się podczas leczenia
Ramy czasowe: Do miesiąca 12 i miesiąca 24
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Do miesiąca 12 i miesiąca 24
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Liczba zgonów
Ramy czasowe: Do miesiąca 6, miesiąca 12 i miesiąca 24
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Do miesiąca 6, miesiąca 12 i miesiąca 24
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Liczba działań niepożądanych prowadzących do przerwania leczenia
Ramy czasowe: Do miesiąca 6, miesiąca 12 i miesiąca 24
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Do miesiąca 6, miesiąca 12 i miesiąca 24
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Time to treatment related discontinuation (=Failure) (TRDF)
Ramy czasowe: From Baseline (Day 1) up to Month 6
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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. |
From Baseline (Day 1) up to Month 6
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Number of participants with confirmed protocol-defined virologic failure (VF)
Ramy czasowe: From Baseline (Day 1) up to Month 6
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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). |
From Baseline (Day 1) up to Month 6
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Number of participants with serious adverse events (SAEs)
Ramy czasowe: Up to Month 6, Month 12, and Month 24
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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. |
Up to Month 6, Month 12, and Month 24
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Number of participants with Grade 2 to 5 drug-related adverse events (AEs)
Ramy czasowe: Up to Month 6, Month 12, and Month 24
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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. |
Up to Month 6, Month 12, and Month 24
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Infekcje przenoszone przez krew
- Choroby układu moczowo-płciowego
- Choroby narządów płciowych
- Choroby układu odpornościowego
- Infekcje
- Zakażenia wirusem RNA
- Choroby wirusowe
- Choroby zakaźne
- Choroby przenoszone drogą płciową, wirusowe
- Choroby przenoszone drogą płciową
- Infekcje lentiwirusowe
- Zakażenia Retroviridae
- Zespoły niedoboru odporności
- Zakażenia wirusem HIV
Inne numery identyfikacyjne badania
- 221611
- 2024-515070-28-00 (Inny identyfikator: EU CT)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Ramy czasowe udostępniania IPD
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Kryteria dostępu do udostępniania IPD
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .