- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania, 12157
- Pfizer Investigational Site
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Berlin, Alemania, 10243
- Pfizer Investigational Site
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Frankfurt am Main, Alemania, 60590
- Pfizer Investigational Site
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Hamburg, Alemania, 20146
- Pfizer Investigational Site
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Koeln, Alemania, 50937
- Pfizer Investigational Site
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Muenchen, Alemania, 80335
- Pfizer Investigational Site
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Alicante, España, 03010
- Pfizer Investigational Site
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Barcelona, España, 08036
- Pfizer Investigational Site
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Cordoba, España, 14004
- Pfizer Investigational Site
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Madrid, España, 28046
- Pfizer Investigational Site
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Sevilla, España, 41013
- Pfizer Investigational Site
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Barcelona
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L'hospitalet de Llobregat, Barcelona, España, 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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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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))
Otros nombres:
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))
Otros nombres:
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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))
Otros nombres:
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))
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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)
Periodo de tiempo: Week 48
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Week 48
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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HIV-1 RNA Levels at Baseline
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Enfermedades de virus lentos
- Infecciones por VIH
- Síndrome de inmunodeficiencia adquirida
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de la transcriptasa inversa
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Agentes Anti-VIH
- Agentes antirretrovirales
- Inhibidores de la proteasa
- Inhibidores del citocromo P-450 CYP3A
- Inhibidores de enzimas del citocromo P-450
- Inhibidores de la proteasa del VIH
- Inhibidores de la proteasa viral
- Inhibidores de la fusión del VIH
- Inhibidores de proteínas de fusión viral
- Antagonistas del receptor CCR5
- Tenofovir
- Emtricitabina
- Ritonavir
- Lopinavir
- Maraviroc
- Darunavir
- Sulfato de atazanavir
Otros números de identificación del estudio
- A4001078
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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