Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292) (onceMRK)
2019년 1월 11일 업데이트: Merck Sharp & Dohme LLC
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects
To evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with TRUVADA™ in HIV-1 infected, treatment-naive participants.
The primary hypothesis being tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL at Week 48.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
802
단계
- 3단계
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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- HIV-1 positive
- Naïve to antiretroviral therapy including investigational antiretroviral agents
- Not of reproductive potential or, if of reproductive potential agrees to 1) true abstinence, or 2) use of an acceptable method of birth control during the study
Exclusion Criteria:
- Use of recreational or illicit drugs or has recent history of drug or alcohol abuse or dependence
- Has been treated for a viral infection other than HIV-1 (such as hepatitis B) with an agent that is active against HIV-1 including but not limited to adefovir, tenofovir, entecavir, emtricitabine, or lamivudine
- Has documented or known resistance to raltegravir, emtricitabine, and/or tenofovir before the first dose of study drug
- Has participated in a study with an investigational compound or device within 30 days or anticipates participating in such a study during this study
- Has used systemic immunosuppressive therapy or immune modulators within 30 days or is anticipated to need them during the study (short courses of corticosteroids are allowed)
- Requires or is anticipated to require any of the following prohibited medications while in the study: phenobarbital, phenytoin, rifampin, rifabutin, or calcium, magnesium and aluminum containing antacids, such as TUMS™, Maalox™ and Milk of Magnesia™
- Has significant hypersensitivity or other contraindication to any of the components of the study drugs
- Has current, active diagnosis of acute hepatitis due to any cause
- Is pregnant, breastfeeding, or expecting to conceive during the study
- Female participant expecting to donate eggs or male participant expecting to donate sperm during the study
- Is or has a family member (spouse or children) who is investigational staff or sponsor staff directly involved in this trial
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: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Reformulated Raltegravir
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
|
Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily
Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label)
Placebo to raltegravir 1 tablet orally twice daily
|
|
활성 비교기: Raltegravir
Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
|
Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label)
Raltegravir 400 mg tablet orally twice daily
Placebo to reformulated raltegravir 2 tablets orally once daily
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48
기간: Week 48
|
From blood samples collected at week 48, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL.
The NC=F approach as defined by FDA "snapshot" approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason.
|
Week 48
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 96
기간: Week 96
|
From blood samples collected at week 96, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL.
The NC=F approach as defined by FDA "snapshot" approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason.
|
Week 96
|
|
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48
기간: Baseline and Week 48
|
CD4 cells were counted from blood collected at baseline and week 48, and the change from baseline determined from week 48 minus baseline values.
|
Baseline and Week 48
|
|
Change From Baseline in CD4 Cell Count at Week 96
기간: Baseline and Week 96
|
CD4 cells were counted from blood collected at baseline and week 96, and the change from baseline determined from week 96 minus baseline values.
|
Baseline and Week 96
|
|
Percentage of Participants With an Adverse Event (AE) at Week 48
기간: Up to Week 48
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
|
Up to Week 48
|
|
Percentage of Participants With an AE After 96 Weeks of Treatment
기간: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
|
Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
|
|
Percentage of Participants With a Drug-Related AE at Week 48
기간: Up to Week 48
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
An investigator who is a qualified physician evaluated whether or not an AE was drug-related.
|
Up to Week 48
|
|
Percentage of Participants With a Drug-Related AE After 96 Weeks of Treatment
기간: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
An investigator who is a qualified physician evaluated whether or not an AE was drug-related.
|
Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
|
|
Percentage of Participants With a Serious Adverse Event (SAE) at Week 48
기간: Up to Week 48
|
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.
|
Up to Week 48
|
|
Percentage of Participants With a SAE After 96 Weeks of Treatment
기간: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
|
A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.
|
Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
|
|
Percentage of Participants With a Serious and Drug-Related AE at Week 48
기간: Up to Week 48
|
A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.
An investigator who is a qualified physician evaluated whether or not a SAE is drug-related.
|
Up to Week 48
|
|
Percentage of Participants With a Serious and Drug-Related AE After 96 Weeks of Treatment
기간: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
|
A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.
An investigator who is a qualified physician evaluated whether or not a SAE is drug-related.
|
Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
|
|
Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48
기간: Up to Week 48
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE
|
Up to Week 48
|
|
Percentage of Participants Who Discontinued From Drug Therapy Due to an AE up to Week 96
기간: Up to Week 96
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE
|
Up to Week 96
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Cahn P, Kaplan R, Sax PE, Squires K, Molina JM, Avihingsanon A, Ratanasuwan W, Rojas E, Rassool M, Bloch M, Vandekerckhove L, Ruane P, Yazdanpanah Y, Katlama C, Xu X, Rodgers A, East L, Wenning L, Rawlins S, Homony B, Sklar P, Nguyen BY, Leavitt R, Teppler H; ONCEMRK Study Group. Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial. Lancet HIV. 2017 Nov;4(11):e486-e494. doi: 10.1016/S2352-3018(17)30128-5. Epub 2017 Sep 11.
- Cahn P, Sax PE, Squires K, Molina JM, Ratanasuwan W, Rassool M, Bloch M, Xu X, Zhou Y, Homony B, Hepler D, Teppler H, Hanna GJ, Nguyen BY, Greaves W; ONCEMRK Study Group. Raltegravir 1200 mg Once Daily vs 400 mg Twice Daily, With Emtricitabine and Tenofovir Disoproxil Fumarate, for Previously Untreated HIV-1 Infection: Week 96 Results From ONCEMRK, a Randomized, Double-Blind, Noninferiority Trial. J Acquir Immune Defic Syndr. 2018 Aug 15;78(5):589-598. doi: 10.1097/QAI.0000000000001723.
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)
2014년 5월 23일
기본 완료 (실제)
2015년 12월 21일
연구 완료 (실제)
2016년 12월 19일
연구 등록 날짜
최초 제출
2014년 5월 2일
QC 기준을 충족하는 최초 제출
2014년 5월 2일
처음 게시됨 (추정)
2014년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 1월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 1월 11일
마지막으로 확인됨
2019년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0518-292
- 2013-001939-47 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
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. .
HIV 감염에 대한 임상 시험
-
Duke UniversityGilead Sciences모병HIV 예방 | HIV 사전 노출 예방 | HIV 예방 프로그램 | HIV 예방 및 관리 | HIV 사전 노출 예방 사용미국
-
Institute of HIV Research and Innovation Foundation...National Institutes of Health (NIH)모병
-
ANRS, Emerging Infectious Diseases아직 모집하지 않음항레트로바이러스 요법 | HIV-1 감염 | HIV 저장소
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)모병
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH)모병실행할 수 있음 | HIV 예방 | PrEP 흡수 | 수용 가능성 | HIV 자가 테스트 | HIV 음성 산후 여성의 남성 파트너남아프리카
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State University of New York at BuffaloYale University Center for Interdisciplinary Research on AIDS아직 모집하지 않음HIV 예방 | HIV 테스트 | 성 및 생식 건강미국
-
Hospital Clinic of Barcelona완전한
-
Thomas Aagaard RasmussenAarhus University Hospital; The Alfred; Germans Trias i Pujol Hospital; Walter and Eliza Hall...모병
-
Instituto Mexicano del Seguro Social모병체중 감량 | 에이즈 | HIV-1 감염 | 체중 변화 | HIV 관련 체중 감소 | 인테그라제 억제제, HIV; HIV 프로테아제 억제멕시코
Reformulated Raltegravir에 대한 임상 시험
-
IrsiCaixa완전한
-
Rush University Medical CenterMerck Sharp & Dohme LLC빼는