Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients (SPARTAN)
2 de fevereiro de 2015 atualizado por: Bristol-Myers Squibb
An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.
The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
Allocation: Randomized nonstratified
Intervention model: Parallel versus comparator
Tipo de estudo
Intervencional
Inscrição (Real)
132
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Bochum, Alemanha, 44791
- Local Institution
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Frankfurt, Alemanha, 60590
- Local Institution
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Frankfurt Am Main, Alemanha, 60311
- Local Institution
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Hamburg, Alemanha, 20246
- Local Institution
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Munich, Alemanha, 80336
- Local Institution
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Alicante, Espanha, 03010
- Local Institution
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Barcelona, Espanha, 08036
- Local Institution
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Madrid, Espanha, 28006
- Local Institution
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Madrid, Espanha, 28007
- Local Institution
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Madrid, Espanha, 28046
- Local Institution
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Madrid, Espanha, 28805
- Local Institution
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72207
- Health For Life Clinic Pllc
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California
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Palm Springs, California, Estados Unidos, 92264
- Eisenhower Medical Center
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San Francisco, California, Estados Unidos, 94109
- Metropolis Medical Pc
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Florida
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Daytona Beach, Florida, Estados Unidos, 32117
- Consultive Medicine
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Orlando, Florida, Estados Unidos, 32805
- Orange County Health Dept.
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West Palm Beach, Florida, Estados Unidos, 33401
- Triple O Medical Services, P.A.
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Massachusetts
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Springfield, Massachusetts, Estados Unidos, 01105
- The Research Institute
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New York
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Rochester, New York, Estados Unidos, 14607
- Aids Care
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Lyons Cedex 04, França, 69317
- Local Institution
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Orleans Cedex 2, França, 45067
- Local Institution
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Paris, França, 75020
- Local Institution
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Paris Cedex 14, França, 75679
- Local Institution
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Strasbourg Cedex, França, 67091
- Local Institution
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Cedex 12
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Paris, Cedex 12, França, 75551
- Local Institution
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Genova, Itália, 16128
- Local Institution
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Genova, Itália, 16132
- Local Institution
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Milano, Itália, 20127
- Local Institution
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Milano, Itália, 20142
- Local Institution
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Roma, Itália, 00149
- Local Institution
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Warszawa, Polônia, 01-201
- Local Institution
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Wroclaw, Polônia, 50-136
- Local Institution
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Brighton, Reino Unido, BN2 1ES
- Local Institution
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London, Reino Unido, E9 6SR
- Local Institution
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London, Reino Unido, NW3 2QG
- Local Institution
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Sheffield, Reino Unido, S10 2RX
- Local Institution
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Greater London
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London, Greater London, Reino Unido, SW10 9EL
- Local Institution
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Greater Manchester
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Manchester, Greater Manchester, Reino Unido, M8 5RB
- Local Institution
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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
Key Inclusion Criteria
- Current treatment regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus any third agent for at least 3 months immediately prior to screening
- Virologic suppression (HIV-1 RNA <50 c/mL) for at least 3 months immediately prior to screening
- Virologic suppression (HIV-1 RNA <40 c/mL) using the Abbott m2000rt® polymerase chain reaction assay during screening period
- Treatment-related safety and/or tolerability issues to a regimen consisting of 2 NRTIs plus any third agent
Key Exclusion Criteria
- History of switch in highly active antiretroviral therapy due to virologic failure
- History of genotypic resistance to any component of the study regimen (atazanavir, raltegravir, tenofovir/emtricitabine)
- History of exposure to atazanavir/ritonavir or raltegravir prior to entering the study
- Experiencing safety and/or tolerability issues to tenofovir/emtricitabine or raltegravir
- Switch of any component of HIV antiretroviral medication regimen in the last 3 months immediately prior to or during the screening period
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
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Capsules, Oral, 300mg, Once daily, 48 weeks
Outros nomes:
Tablets, Oral, 100 mg, Once daily, 48 weeks
Outros nomes:
Tablets, Oral, 400 mg, Twice daily, 48 weeks
Outros nomes:
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Outro: Atazanavir/Ritonavir + Tenofovir/Emtricitabine
Reference Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine |
Capsules, Oral, 300mg, Once daily, 48 weeks
Outros nomes:
Tablets, Oral, 100 mg, Once daily, 48 weeks
Outros nomes:
Tablets, Oral, 300/200 mg, Once daily, 48 weeks
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
Prazo: From Day 1 to Week 24
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HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay.
Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients.
Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders.
Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation.
Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures.
RNA=ribonucleic acid; HIV=human immunodeficiency virus.
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From Day 1 to Week 24
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
Prazo: From Day 1 to Week 48
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Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit.
Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals.
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From Day 1 to Week 48
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Number of Participants With Virologic Rebound at Weeks 24 and 48
Prazo: Day 1 to Weeks 28 and 48
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Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL).
Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing.
Genotypic substitutions at baseline were summarized for virologic rebound.
The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database.
Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.
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Day 1 to Weeks 28 and 48
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Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24
Prazo: Day 1 to Week 24
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Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL).
Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing.
Genotypic substitutions at baseline were summarized for virologic rebound.
The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database.
Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.
pts=patients
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Day 1 to Week 24
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Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48
Prazo: Day 1 to Week 48
|
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL).
Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing.
Genotypic substitutions at baseline were summarized for virologic rebound.
The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database.
Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.
pts=patients
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Day 1 to Week 48
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Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs
Prazo: Day 1 to Week 48
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AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Related=having certain, probable, possible, or unknown relationship to study drug.
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Day 1 to Week 48
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Mean Changes in Fasting Lipid Levels From Baseline to Week 48
Prazo: From Baseline to Week 48
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LD=low-density lipoprotein; HDL=high-density lipoprotein.
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From Baseline to Week 48
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Bristol-Mayers Squibb, Bristol-Mayers Squibb
Publicações e links úteis
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Links úteis
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
1 de outubro de 2011
Conclusão Primária (Real)
1 de setembro de 2013
Conclusão do estudo (Real)
1 de fevereiro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
7 de abril de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de abril de 2011
Primeira postagem (Estimativa)
11 de abril de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
19 de fevereiro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de fevereiro de 2015
Última verificação
1 de fevereiro de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- 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 de Protease
- Inibidores do citocromo P-450 CYP3A
- Inibidores da enzima citocromo P-450
- Inibidores da Integrase do HIV
- Inibidores de integrase
- Inibidores da Protease do HIV
- Inibidores de Protease Viral
- Tenofovir
- Emtricitabina
- Potássio Raltegravir
- Ritonavir
- Sulfato de Atazanavir
Outros números de identificação do estudo
- AI424-402
- 2009-017032-41 (Número EudraCT)
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 .