- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00827112
A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients
Pilot Study Of Novel Combination Of Maraviroc + Atazanavir/Ritonavir vs. Atazanavir/Ritonavir + Emtricitabine/Tenofovir For The Treatment Of Naïve HIV-Infected Patients With R5 HIV-1
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Berlin, Alemanha, 12157
- Pfizer Investigational Site
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Berlin, Alemanha, 10243
- Pfizer Investigational Site
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Frankfurt am Main, Alemanha, 60590
- Pfizer Investigational Site
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Hamburg, Alemanha, 20146
- Pfizer Investigational Site
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Koeln, Alemanha, 50937
- Pfizer Investigational Site
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Muenchen, Alemanha, 80335
- Pfizer Investigational Site
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Alicante, Espanha, 03010
- Pfizer Investigational Site
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Barcelona, Espanha, 08036
- Pfizer Investigational Site
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Cordoba, Espanha, 14004
- Pfizer Investigational Site
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Madrid, Espanha, 28046
- Pfizer Investigational Site
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Sevilla, Espanha, 41013
- Pfizer Investigational Site
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Barcelona
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L'hospitalet de Llobregat, Barcelona, Espanha, 08907
- Pfizer Investigational Site
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California
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Los Angeles, California, Estados Unidos, 90048
- Pfizer Investigational Site
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Los Angeles, California, Estados Unidos, 90069
- Pfizer Investigational Site
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Los Angeles, California, Estados Unidos, 90027
- Pfizer Investigational Site
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Los Angeles, California, Estados Unidos, 90028
- Pfizer Investigational Site
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Connecticut
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Norwalk, Connecticut, Estados Unidos, 06851
- Pfizer Investigational Site
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20009
- Pfizer Investigational Site
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Florida
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Miami, Florida, Estados Unidos, 33136
- Pfizer Investigational Site
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Miami, Florida, Estados Unidos, 33133
- Pfizer Investigational Site
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Miami, Florida, Estados Unidos, 33137
- Pfizer Investigational Site
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Orlando, Florida, Estados Unidos, 32803
- Pfizer Investigational Site
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Pensacola, Florida, Estados Unidos, 32504
- Pfizer Investigational Site
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St. Petersburg, Florida, Estados Unidos, 33713
- Pfizer Investigational Site
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Tampa, Florida, Estados Unidos, 33602
- Pfizer Investigational Site
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Tampa, Florida, Estados Unidos, 33614
- Pfizer Investigational Site
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Georgia
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Atlanta, Georgia, Estados Unidos, 30312
- Pfizer Investigational Site
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Illinois
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Chicago, Illinois, Estados Unidos, 60657
- Pfizer Investigational Site
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Massachusetts
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Springfield, Massachusetts, Estados Unidos, 01107
- Pfizer Investigational Site
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Springfield, Massachusetts, Estados Unidos, 01199
- Pfizer Investigational Site
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- Pfizer Investigational Site
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68106
- Pfizer Investigational Site
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New York
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New York, New York, Estados Unidos, 10003
- Pfizer Investigational Site
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North Carolina
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Huntersville, North Carolina, Estados Unidos, 28078
- Pfizer Investigational Site
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Texas
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Addison, Texas, Estados Unidos, 75001
- Pfizer Investigational Site
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Dallas, Texas, Estados Unidos, 75204
- Pfizer Investigational Site
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Dallas, Texas, Estados Unidos, 75390
- Pfizer Investigational Site
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Houston, Texas, Estados Unidos, 77098
- Pfizer Investigational Site
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Washington
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Spokane, Washington, Estados Unidos, 99204
- Pfizer Investigational Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- HIV-1 RNA viral load of ≥1,000 copies/mL measured at the Screening Visit.
- CD4 count ≥100 cells/mm3 at Screening.
- Have only R5 HIV-1 at Screening as verified by the Monogram Bioscience Trofile® assay with enhanced sensitivity.
Exclusion Criteria:
- Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
- Any evidence of resistance to atazanavir, tenofovir, and emtricitabine.
- X4-or dual/mixed-tropic virus by enhanced Trofile assay or repeated assay failure or not reportable results.
Plano de estudo
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: Arm A
maraviroc (Selzentry, Celsentri) 150 mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir (Reyataz) in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir (Prezista)/ritonavir (Norvir)((800/100 mg) QD or lopinavir/ritonavir (Kaletra, Aluvia)(400/100mg) BID and remain in the study.
If the investigator decides to switch to a protease inhibitor other than darunavir (Prezista)/ritonavir (Norvir) or lopinavir/ritonavir (Kaletra, Aluvia)(, then the subject must be discontinued from the study.
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maraviroc (Selzentry, Celsentri) 150mg QD + atazanavir (Reyataz) /ritonavir (Norvir) (300/100mg) QD OR maraviroc (Selzentry, Celsentri) 150mg QD+ darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR maraviroc (Selzentry, Celsentri) 150mg QD+ lopinavir/ritonavir (Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
Outros nomes:
emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + lopinavir/ritonavir(Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
Outros nomes:
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Experimental: Arm B
emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir/ritonavir (800/100 mg) QD or lopinavir/ritonavir (400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir/ritonavir or lopinavir/ritonavir, then the subject must be discontinued from the study. |
maraviroc (Selzentry, Celsentri) 150mg QD + atazanavir (Reyataz) /ritonavir (Norvir) (300/100mg) QD OR maraviroc (Selzentry, Celsentri) 150mg QD+ darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR maraviroc (Selzentry, Celsentri) 150mg QD+ lopinavir/ritonavir (Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
Outros nomes:
emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + lopinavir/ritonavir(Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)
Prazo: Week 48
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Week 48
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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HIV-1 RNA Levels at Baseline
Prazo: Baseline
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Baseline
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Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
Prazo: Baseline , Days 4, 7, 10 and 14
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Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only.
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Baseline , Days 4, 7, 10 and 14
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Maximum Observed Plasma Concentration (Cmax) of Maraviroc
Prazo: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
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Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
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Minimum Observed Plasma Concentration (Cmin) of Maraviroc
Prazo: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
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Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
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Average Observed Plasma Concentration (Cavg) of Maraviroc
Prazo: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
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Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24).
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Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
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Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
Prazo: Baseline, Week 16, Week 24, Week 48, Week 96
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Baseline, Week 16, Week 24, Week 48, Week 96
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Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
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Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
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Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
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Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
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Time to Loss of Virological Response (TLOVR)
Prazo: Baseline through Week 96
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TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm.
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Baseline through Week 96
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Time-Averaged Difference (TAD) in log10 Viral Load
Prazo: Week 16, Week 24, Week 48, Week 96
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TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL).
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Week 16, Week 24, Week 48, Week 96
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Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
Prazo: Baseline, Week 16, Week 24, Week 48, Week 96
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Baseline, Week 16, Week 24, Week 48, Week 96
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Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
Prazo: Baseline, Week 16, Week 24, Week 48, Week 96
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Baseline, Week 16, Week 24, Week 48, Week 96
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Number of Participants With Genotypic Resistance
Prazo: Week 96 or Time of treatment failure
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Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays.
This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
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Week 96 or Time of treatment failure
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Number of Participants With Phenotypic Resistance
Prazo: Week 96 or Time of treatment failure
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Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays.
This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.
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Week 96 or Time of treatment failure
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Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
Prazo: Baseline to Week 96 or Time of treatment Failure
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Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL.
The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population.
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Baseline to Week 96 or Time of treatment Failure
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
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
- Doenças de Vírus Lento
- Infecções por HIV
- Síndrome da Imunodeficiência Adquirida
- 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 Protease do HIV
- Inibidores de Protease Viral
- Inibidores de Fusão do HIV
- Inibidores de proteína de fusão viral
- Antagonistas do Receptor CCR5
- Tenofovir
- Emtricitabina
- Ritonavir
- Lopinavir
- Maraviroc
- Darunavir
- Sulfato de Atazanavir
Outros números de identificação do estudo
- A4001078
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 .
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