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- Ensaio Clínico NCT02131233
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)
11 de janeiro de 2019 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
802
Estágio
- Fase 3
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 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
|
Comparador Ativo: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 96
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
23 de maio de 2014
Conclusão Primária (Real)
21 de dezembro de 2015
Conclusão do estudo (Real)
19 de dezembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
2 de maio de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de maio de 2014
Primeira postagem (Estimativa)
6 de maio de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de janeiro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de janeiro de 2019
Última verificação
1 de janeiro de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções transmitidas pelo sangue
- Doenças Transmissíveis
- Doenças Sexualmente Transmissíveis, Virais
- Doenças Sexualmente Transmissíveis
- Infecções por Lentivírus
- Infecções por Retroviridae
- Síndromes de Deficiência Imunológica
- Doenças do sistema imunológico
- Infecções por HIV
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Antivirais
- Inibidores da transcriptase reversa
- Inibidores da Síntese de Ácido Nucleico
- Inibidores Enzimáticos
- Agentes anti-HIV
- Antirretrovirais
- Inibidores da Integrase do HIV
- Inibidores de integrase
- Potássio Raltegravir
- Emtricitabina, Fumarato de Tenofovir Disoproxil Combinação de Medicamentos
Outros números de identificação do estudo
- 0518-292
- 2013-001939-47 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Infecção pelo HIV
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRecrutamentoHIV | Teste de HIV | Ligação do HIV ao Cuidado | Tratamento de HIVEstados Unidos
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement e outros colaboradoresDesconhecidoHIV | Crianças não infectadas pelo HIV | Crianças expostas ao HIVCamarões
-
University of MinnesotaRetiradoInfecções por HIV | HIV/AIDS | HIV | AUXILIA | Aids/problema de HIV | AIDS e InfecçõesEstados Unidos
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationConcluídoTeste de HIV do parceiro | Aconselhamento de casal HIV | Comunicação de casal | Incidência de HIVCamarões, República Dominicana, Geórgia, Índia
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... e outros colaboradoresRecrutamentoHIV | Teste de HIV | Vinculação ao cuidadoÁfrica do Sul
-
CDC FoundationGilead SciencesDesconhecidoProfilaxia pré-exposição ao HIV | Quimioprofilaxia HIVEstados Unidos
-
Erasmus Medical CenterAinda não está recrutandoInfecções por HIV | HIV | Infecção por HIV-1 | Infecção HIV IHolanda
-
Helios SaludViiV HealthcareDesconhecidoHIV | Infecção por HIV-1Argentina
-
National Taiwan UniversityRecrutamento
-
University of Maryland, BaltimoreRetiradoHIV | Transplante de rim | Reservatório de HIV | CCR5Estados Unidos
Ensaios clínicos em Reformulated Raltegravir
-
ViiV HealthcareConcluídoInfecção, Vírus da Imunodeficiência HumanaEstados Unidos
-
Merck Sharp & Dohme LLCConcluído
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...ConcluídoInfecções por HIVEstados Unidos, Porto Rico, África do Sul, Argentina, Brasil, Botsuana
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ViiV HealthcareGlaxoSmithKline; ShionogiConcluídoInfecções por HIV | Infecção, Vírus da Imunodeficiência HumanaEstados Unidos, França, Holanda, Espanha, Taiwan, Austrália, Bélgica, Federação Russa, Canadá, Reino Unido, México, Itália, África do Sul, Romênia, Argentina, Hungria, Polônia, Chile, Grécia, Brasil
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ViiV HealthcareGlaxoSmithKline; ShionogiConcluídoInfecção, Vírus da Imunodeficiência Humana IAlemanha, Espanha, França, Austrália, Estados Unidos, Canadá, Reino Unido, Itália, Federação Russa
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ANRS, Emerging Infectious DiseasesConcluídoInfecção por HIV-1 | GRAVIDEZFrança
-
IrsiCaixaConcluído
-
Bristol-Myers SquibbMerck Sharp & Dohme LLCConcluído
-
National Institute of Allergy and Infectious Diseases...ConcluídoInfecções por HIV | TuberculoseÁfrica do Sul