이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

HIV-1이 검출된 참가자에게 투여 시 지속성(LA) 카보테그라비르(CAB) + 릴피비린(RPV) LA의 효과를 평가하기 위한 연구 (CROWN)

2026년 11월 9일 업데이트: ViiV Healthcare

HIV-1에 감염된 바이러스성 참가자(CROWN)에서 주사용 CAB LA + RPV LA의 효능, 안전성 및 내약성을 평가하는 3b상, 오픈 라벨, 무작위, 표준 치료 대조군, 다기관, 우월성 연구

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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

326

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 독일
      • Berlin, 독일, 10439
        • GSK Investigational Site
      • Cologne, 독일, 50668
        • GSK Investigational Site
      • Frankfurt, 독일, 60596
        • GSK Investigational Site
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, 독일, 50674
        • GSK Investigational Site
      • Düsseldorf, North Rhine-Westphalia, 독일, 40225
        • GSK Investigational Site
  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35222
        • GSK Investigational Site
    • California
      • Los Angeles, California, 미국, 90069
        • GSK Investigational Site
      • Los Angeles, California, 미국, 90036
        • GSK Investigational Site
      • Los Angeles, California, 미국, 90035
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, 미국, 80045
        • GSK Investigational Site
      • Denver, Colorado, 미국, 80204
        • GSK Investigational Site
    • Connecticut
      • New Haven, Connecticut, 미국, 06510
        • GSK Investigational Site
    • Delaware
      • Newark, Delaware, 미국, 19711
        • GSK Investigational Site
    • District of Columbia
      • Washington D.C., District of Columbia, 미국, 20017
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, 미국, 32209
        • GSK Investigational Site
      • Miami, Florida, 미국, 33136
        • GSK Investigational Site
      • Sarasota, Florida, 미국, 34237-3116
        • GSK Investigational Site
      • West Palm Beach, Florida, 미국, 33409
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, 미국, 30308
        • GSK Investigational Site
      • Decatur, Georgia, 미국, 30033
        • GSK Investigational Site
      • Macon, Georgia, 미국, 31201
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, 미국, 60637
        • GSK Investigational Site
      • Chicago, Illinois, 미국, 60613
        • GSK Investigational Site
      • Chicago, Illinois, 미국, 60611-2826
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, 미국, 21201
        • GSK Investigational Site
      • Baltimore, Maryland, 미국, 21287
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • GSK Investigational Site
    • Michigan
      • Berkley, Michigan, 미국, 48072
        • GSK Investigational Site
    • Missouri
      • Kansas City, Missouri, 미국, 64111
        • GSK Investigational Site
      • St Louis, Missouri, 미국, 63110-1035
        • GSK Investigational Site
    • New Jersey
      • Newark, New Jersey, 미국, 07102
        • GSK Investigational Site
    • New York
      • Hawthorne, New York, 미국, 10532-2140
        • GSK Investigational Site
      • New York, New York, 미국, 10032
        • GSK Investigational Site
      • New York, New York, 미국, 10010
        • GSK Investigational Site
      • The Bronx, New York, 미국, 10467
        • GSK Investigational Site
      • The Bronx, New York, 미국, 10468-3904
        • GSK Investigational Site
    • North Carolina
      • Greensboro, North Carolina, 미국, 27401-1209
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, 미국, 45267
        • GSK Investigational Site
      • Columbus, Ohio, 미국, 43210
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, 미국, 75246-2004
        • GSK Investigational Site
      • Houston, Texas, 미국, 77030
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, 미국, 98104-2420
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, 미국, 53212
        • GSK Investigational Site
  • 벨기에
      • Antwerp, 벨기에, 2000
        • GSK Investigational Site
  • 스페인
      • Barcelona, 스페인, 08036
        • GSK Investigational Site
      • Barcelona, 스페인, 08035
        • GSK Investigational Site
      • Barcelona, 스페인, 08003
        • GSK Investigational Site
      • Barcelona, 스페인, 08026
        • GSK Investigational Site
      • Córdoba, 스페인, 14004
        • GSK Investigational Site
      • Madrid, 스페인, 28041
        • GSK Investigational Site
      • Madrid, 스페인, 28006
        • GSK Investigational Site
      • Madrid, 스페인, 28007
        • GSK Investigational Site
      • Madrid, 스페인, 28040
        • GSK Investigational Site
      • Madrid, 스페인, 28046
        • GSK Investigational Site
      • Madrid, 스페인, 28034
        • GSK Investigational Site
      • Madrid, 스페인, 28031
        • GSK Investigational Site
      • Madrid, 스페인, 28020
        • GSK Investigational Site
      • Murcia, 스페인, 30120
        • GSK Investigational Site
      • Málaga, 스페인, 29010
        • GSK Investigational Site
      • Málaga, 스페인, 29530
        • GSK Investigational Site
      • Palma de Mallorca, 스페인, 07120
        • GSK Investigational Site
      • Sabadell Barcelona, 스페인, 08208
        • GSK Investigational Site
      • Seville, 스페인, 41013
        • GSK Investigational Site
      • Vigo Pontevedra, 스페인, 36312
        • GSK Investigational Site
      • Zaragoza, 스페인, 50009
        • GSK Investigational Site
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, 스페인, 08907
        • GSK Investigational Site
    • Bizkaia
      • Bilbao, Bizkaia, 스페인, 48013
        • GSK Investigational Site
    • Cádiz
      • Puerto Real, Cádiz, 스페인, 11510
        • GSK Investigational Site
  • 아르헨티나
      • Buenos Aires, 아르헨티나, 1023
        • GSK Investigational Site
      • Buenos Aires, 아르헨티나, C1425AGC
        • GSK Investigational Site
      • Buenos Aires, 아르헨티나, 1427
        • GSK Investigational Site
      • Capital Federal, 아르헨티나, C1181ACH
        • GSK Investigational Site
      • Ciudad Autonoma Buenos Aires, 아르헨티나, C1405CKC
        • GSK Investigational Site
      • Córdoba, 아르헨티나, X5000JJS
        • GSK Investigational Site
      • Rosario, 아르헨티나, S2000PBJ
        • GSK Investigational Site
  • 이탈리아
      • Bari, 이탈리아
        • GSK Investigational Site
      • Milan, 이탈리아, 20142
        • GSK Investigational Site
      • Milan, 이탈리아, 20127
        • GSK Investigational Site
      • Roma, 이탈리아, 00149
        • GSK Investigational Site
    • BG
      • Bergamo, BG, 이탈리아, 24127
        • GSK Investigational Site
  • 캐나다
    • Quebec
      • Montreal, Quebec, 캐나다, H2L 4P9
        • GSK Investigational Site
      • Montreal, Quebec, 캐나다, H4A 3J1
        • GSK Investigational Site
  • 포르투갈
      • Porto, 포르투갈, 4099-001
        • GSK Investigational Site
      • Porto, 포르투갈, 4200-319
        • GSK Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

12년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 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.

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.

  • 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:

    1. 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.
    2. 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

  1. HIV-1 Subtype A6, if known from historical result.

  2. Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study.

  3. 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).

  4. 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.

  5. History of liver cirrhosis with or without hepatitis viral co-infection.

  6. Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.

  7. Participants with HCV co-infection will be excluded entry into this study if they are currently receiving anti-HCV therapy at baseline (Day 1).

  8. Participants determined by the investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder.

  9. 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.

  10. 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.

  11. 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

  12. Any previous use of CAB.

  13. Current or anticipated need for chronic anti-coagulants.

  14. Use of concomitant medications which are associated with Torsades de Pointes (TdP).

  15. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.

  16. Treatment with any of the following agents within 28 days of Screening:

    1. radiation therapy;
    2. cytotoxic chemotherapeutic agents;
    3. tuberculosis therapy with the exception of isoniazid;
    4. anti-coagulation agents, with the exception of the use of low dose acetylsalicylic acid (<=325mg);
    5. immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons.

  17. 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).

  18. Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.

    • Prior/Concurrent Clinical Study Experience

  19. Participant is currently participating in, or anticipates being selected for, any other interventional study.

    • Diagnostic assessments

  20. 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.

  21. 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.

  22. 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.

  23. ALT >=5 times ULN or ALT >=3×ULN and bilirubin >=1.5×ULN (with >35% direct bilirubin).

  24. 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).

  25. Hemoglobin <9.0 g/dL.

  26. Corrected QT interval (QTc >450 msec or QTc >480 msec for participants with bundle branch block, calculated using ECGs performed in triplicate).

    • Other exclusions

  27. Unwilling to receive injections, or unable to receive gluteal injections.

  28. 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).

  29. 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.

  30. 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: CAB LA + RPV LA

Intramuscular injection administered monthly for first 2 initiation doses then every 2 months.
활성 비교기: Oral ART Control Group

Participants continue to take their current oral ART for 6 months, including a final dose at their first injection visit.
의약품: Oral ART

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of participants with virologic suppression after the CAB LA + RPV LA treatment compared to oral ART
기간: At Month 6

A virologic suppression is defined by HIV-1 RNA less than (<) 50 copies (c)/mL.
At Month 6

2차 결과 측정

결과 측정
측정값 설명
기간
바이러스 억제 시간
기간: 기준선(1일)부터 6개월까지
기준선(1일)부터 6개월까지
치료로 인한 저항성 관련 돌연변이(RAM)가 있는 참가자 수
기간: 기준선(1일)부터 6개월까지
기준선(1일)부터 6개월까지
치료가 필요한 RAM이 있는 참가자 수
기간: 12개월 및 24개월까지
12개월 및 24개월까지
사망자 수
기간: 6개월, 12개월, 24개월까지
6개월, 12개월, 24개월까지
중단으로 이어지는 AE 수
기간: 6개월, 12개월, 24개월까지
6개월, 12개월, 24개월까지
Time to treatment related discontinuation (=Failure) (TRDF)
기간: From Baseline (Day 1) up to Month 6

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
Number of participants with confirmed protocol-defined virologic failure (VF)
기간: From Baseline (Day 1) up to Month 6

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
Number of participants with serious adverse events (SAEs)
기간: Up to Month 6, Month 12, and Month 24

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
Number of participants with Grade 2 to 5 drug-related adverse events (AEs)
기간: Up to Month 6, Month 12, and Month 24

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

ViiV Healthcare

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 12월 2일

기본 완료 (실제)

2026년 8월 19일

연구 완료 (추정된)

2028년 6월 9일

연구 등록 날짜

최초 제출

2024년 11월 15일

QC 기준을 충족하는 최초 제출

2024년 11월 15일

처음 게시됨 (실제)

2024년 11월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 9일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 221611
  • 2024-515070-28-00 (기타 식별자: EU CT)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

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.

IPD 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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