- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02415595
Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults
20 de agosto de 2018 actualizado por: ViiV Healthcare
A Phase 2b Randomized, Active-Controlled, Double-Blind Trial to Investigate Safety, Efficacy, and Dose-response of BMS-955176, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults
The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
210
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania, 13353
- GSK Investigational Site
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Berlin, Alemania, 12157
- GSK Investigational Site
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Dortmund, Alemania, 44137
- GSK Investigational Site
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Bayern
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Muenchen, Bayern, Alemania, 80335
- GSK Investigational Site
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Muenchen, Bayern, Alemania, 80336
- GSK Investigational Site
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Niedersachsen
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Hannover, Niedersachsen, Alemania, 30625
- GSK Investigational Site
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Nordrhein-Westfalen
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Bonn, Nordrhein-Westfalen, Alemania, 53127
- GSK Investigational Site
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Duesseldorf, Nordrhein-Westfalen, Alemania, 40225
- GSK Investigational Site
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Essen, Nordrhein-Westfalen, Alemania, 45122
- GSK Investigational Site
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Buenos Aires, Argentina, 1141
- GSK Investigational Site
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Buenos Aires, Argentina, 1202
- GSK Investigational Site
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Córdoba, Argentina, X5000JJS
- GSK Investigational Site
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACH
- GSK Investigational Site
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Santa Fe
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Rosario, Santa Fe, Argentina, 2000
- GSK Investigational Site
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Quebec, Canadá, G1V 4G2
- GSK Investigational Site
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Alberta
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Edmonton, Alberta, Canadá, T6G 2G3
- GSK Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canadá, R3A 1R9
- GSK Investigational Site
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Ontario
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Ottawa, Ontario, Canadá, K1H 8L6
- GSK Investigational Site
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Quebec
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Montreal, Quebec, Canadá, H3A 1T1
- GSK Investigational Site
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Montreal, Quebec, Canadá, H2L 4P9
- GSK Investigational Site
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Montreal, Quebec, Canadá, H4A 3J1
- GSK Investigational Site
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Montreal, Quebec, Canadá, H2L 5B1
- GSK Investigational Site
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Santiago, Chile, 8360159
- GSK Investigational Site
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Santiago, Chile, 7560994
- GSK Investigational Site
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Región Metro De Santiago
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Santiago, Región Metro De Santiago, Chile
- GSK Investigational Site
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Alcala de Henares, España, 28805
- GSK Investigational Site
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Badalona, España, 08916
- GSK Investigational Site
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Madrid, España, 28040
- GSK Investigational Site
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Madrid, España, 28034
- GSK Investigational Site
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Santiago de Compostela, España, 15706
- GSK Investigational Site
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California
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Beverly Hills, California, Estados Unidos, 90211
- GSK Investigational Site
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Los Angeles, California, Estados Unidos, 90036
- GSK Investigational Site
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Florida
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DeLand, Florida, Estados Unidos, 32720
- GSK Investigational Site
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Georgia
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Atlanta, Georgia, Estados Unidos, 30312
- GSK Investigational Site
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Decatur, Georgia, Estados Unidos, 30033
- GSK Investigational Site
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New Mexico
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Santa Fe, New Mexico, Estados Unidos, 87505
- GSK Investigational Site
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74135
- GSK Investigational Site
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Texas
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Fort Worth, Texas, Estados Unidos, 76104
- GSK Investigational Site
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Le Kremlin-Bicêtre, Francia, 94276
- GSK Investigational Site
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Lyon cedex 04, Francia, 69317
- GSK Investigational Site
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Nantes, Francia, 44093
- GSK Investigational Site
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Nice, Francia, 06202
- GSK Investigational Site
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Paris, Francia, 75013
- GSK Investigational Site
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Paris, Francia, 75012
- GSK Investigational Site
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Paris Cedex 10, Francia, 75475
- GSK Investigational Site
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Lombardia
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Bergamo, Lombardia, Italia, 24127
- GSK Investigational Site
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Milano, Lombardia, Italia, 20127
- GSK Investigational Site
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Milano, Lombardia, Italia, 20157
- GSK Investigational Site
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Monza, Lombardia, Italia, 20900
- GSK Investigational Site
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DF, México, 14000
- GSK Investigational Site
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Durango, México, 34000
- GSK Investigational Site
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Mexico City, México, CP 14080
- GSK Investigational Site
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Aguascalientes
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Fracc. Las Americas, Aguascalientes, México, 20020
- GSK Investigational Site
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Guanajuato
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León, Guanajuato, México, 37000
- GSK Investigational Site
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Bydgoszcz, Polonia, 85-030
- GSK Investigational Site
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Szczecin, Polonia, 71-252
- GSK Investigational Site
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Warszawa, Polonia, 01-201
- GSK Investigational Site
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Wroclaw, Polonia, 50-220
- GSK Investigational Site
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London, Reino Unido, E1 1BB
- GSK Investigational Site
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London, Reino Unido, W2 1NY
- GSK Investigational Site
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London, Reino Unido, SW10 9NH
- GSK Investigational Site
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Tooting, London, Reino Unido, SW17 0QT
- GSK Investigational Site
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Midlothian
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Edinburgh, Midlothian, Reino Unido, EH4 2XU
- GSK Investigational Site
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Free State
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Bloemfontein, Free State, Sudáfrica, 9301
- GSK Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
- Men and non-pregnant women, at least 18 years of age
- Antiretroviral treatment-naïve; defined as no current or previous exposure to > 1 week of an antiretroviral drug
- Plasma HIV-1 RNA ≥ 1000 copies/mL
- CD4 T-cell count > 200 cells/mm3
Exclusion Criteria:
- Resistance or partial resistance to any study drug determined by tests at Screening
- Current or historical genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors
- Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)
- Blood tests that indicate normal liver function
- Hemoglobin < 8.0 g/dL, platelets < 50,000 cells/mm3
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Arm 1: BMS-955176 60 mg + TDF/FTC
BMS-955176 at 60 mg active dose per day + BMS-955176 placebo matching 120 mg + efavirenz (EFV) placebo matching 600 mg + tenofovir/emtricitabine (TDF/FTC) 300/200 mg per day, orally
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Inhibidor de la maduración del VIH
TDF/FTC
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Experimental: Arm 2: BMS-955176 120 mg + TDF/FTC
BMS-955176 placebo matching 60 mg + BMS-955176 at 120mg active dose per day + EFV placebo matching 600mg + TDF/FTC 300/200mg per day, orally
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Inhibidor de la maduración del VIH
TDF/FTC
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Experimental: Arm 3: BMS-955176 180 mg + TDF/FTC
BMS-955176 at 60mg active dose per day + BMS-955176 at 120mg active dose per day + EFV placebo matching 600mg + TDF/FTC at 300/200mg per day, orally
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Inhibidor de la maduración del VIH
TDF/FTC
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Comparador activo: Arm 4: EFV + TDF/FTC
BMS-955176 placebo matching 60mg + BMS-955176 placebo matching 120mg + EFV at 600mg per day + TDF/FTC 300/200mg per day
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TDF/FTC
EFV
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24 Using Food and Drug Administration (FDA) Snapshot Algorithm
Periodo de tiempo: Week 24
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Blood samples were collected for quantitative analysis of plasma HIV-1 RNA.
The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Week 24 using the FDA snapshot algorithm.
This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window (18 to 30 weeks) to determine response.
Analysis was performed on mITT Population, which comprised of randomized participants who received at least 1 dose of BMS-955176/GSK3532795 or EFV.
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Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm
Periodo de tiempo: Weeks 48 and 96
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Blood samples were collected for quantitative analysis of plasma HIV-1 RNA.
The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm.
This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response.
The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016).
The data was not collected for Week 96 analysis; as the study was terminated early.
Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
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Weeks 48 and 96
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Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm
Periodo de tiempo: Week 24
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Blood samples were collected for quantitative analysis of plasma HIV-1 RNA.
The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Week 24 using the FDA snapshot algorithm.
This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response.
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Week 24
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Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96
Periodo de tiempo: Weeks 48 and 96
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Blood samples were collected for quantitative analysis of plasma HIV-1 RNA.
The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm.
This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response.
The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016).
The data was not collected for Week 96 analysis; as the study was terminated early.
Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
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Weeks 48 and 96
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Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates
Periodo de tiempo: Week 24
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The emergence of genotypic resistance among samples selected for drug resistance testing were assessed by searching for all reverse transcriptase substitutions and protease inhibitor substitutions listed in the International Acquired Immunodeficiency Syndrome (AIDS) Society-United States of America (IAS-USA) list of HIV-1 drug resistance mutations.
The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early.
The emergence of genotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment genotypic resistance testing and who had successful sequencing.
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Week 24
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Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates
Periodo de tiempo: Week 24
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Phenotypic resistance to a drug is defined as a fold change (i.e., ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of the reference strain) which is greater than the cut-off for reduced susceptibility.
Emergent phenotypic resistance to BMS-955176/GSK3532795 was defined as a Baseline fold change IC50<= 3 and an on-treatment fold change IC50>3.
The number of participants with newly emergent phenotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment phenotypic resistance testing.
The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early.
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Week 24
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Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time
Periodo de tiempo: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
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Blood samples were collected for analysis of HIV-1 RNA.
Values obtained at Day 1 were considered as Baseline value.
Change from Baseline was calculated as value at indicated time point minus Baseline value.
Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016).
Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.
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Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
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Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time
Periodo de tiempo: Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
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CD4+ T-cell counts was assessed using flow cytometry.
Values obtained at Day 1 were considered as Baseline value.
Change from Baseline was calculated as value at indicated time point minus Baseline value.
Change from Baseline in CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016).
Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.
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Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
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Change From Baseline in the Percentage of CD4+ T-cells Over Time
Periodo de tiempo: Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
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CD4+ T-cell counts overall was assessed using flow cytometry.
Values obtained at Day 1 were considered as Baseline value.
Change from Baseline was calculated as value at indicated time point minus Baseline value.
Change from Baseline in percentage of CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016).
Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.
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Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
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Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD)
Periodo de tiempo: Up to Week 96
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Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE.
Number of participants with SAEs and AELDs is summarized.
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Up to Week 96
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Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events
Periodo de tiempo: Up to Week 96
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The occurrence of new AIDS defining events that is CDC class C events is presented.
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Up to Week 96
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Maximum Observed Plasma Concentration (Cmax), Observed Pre-dose Plasma Concentration (C0) and Observed Plasma Concentration at the End of a Dosing Interval (Ctau) of BMS-955176/GSK3532795
Periodo de tiempo: Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
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Serial blood samples were collected at indicated time points for intensive pharmacokinetic (PK) assessment.
The PK assessments were performed on evaluable PK Population, a sub-population which included all treated participants who had adequate PK profiles.
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Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
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Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795
Periodo de tiempo: Pre-dose (morning) and 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
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Serial blood samples were collected at indicated time points for intensive PK assessment.
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Pre-dose (morning) and 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
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Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795
Periodo de tiempo: Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
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Serial blood samples were collected at indicated time points for intensive PK assessment.
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Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
12 de mayo de 2015
Finalización primaria (Actual)
26 de mayo de 2016
Finalización del estudio (Actual)
21 de agosto de 2017
Fechas de registro del estudio
Enviado por primera vez
11 de marzo de 2015
Primero enviado que cumplió con los criterios de control de calidad
9 de abril de 2015
Publicado por primera vez (Estimar)
14 de abril de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
20 de agosto de 2018
Última verificación
1 de agosto de 2018
Más información
Términos relacionados con este estudio
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
- Agentes antiinfecciosos
- Agentes Antivirales
- Agentes Anti-VIH
- Agentes antirretrovirales
- BMS-955176
Otros números de identificación del estudio
- 205891
- 2013-005487-26 (Número EudraCT)
- AI468-038 (Otro identificador: Bristol-Myers Squibb)
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. .
Ensayos clínicos sobre BMS-955176
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ViiV HealthcareGlaxoSmithKlineTerminadoInfección, Virus De La Inmunodeficiencia HumanaEstados Unidos
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ViiV HealthcareGlaxoSmithKlineTerminadoInfecciones por VIHEstados Unidos
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ViiV HealthcareGlaxoSmithKlineTerminadoInfección, Virus De La Inmunodeficiencia HumanaReino Unido
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ViiV HealthcareGlaxoSmithKlineTerminado
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ViiV HealthcareSenopsys, LLCTerminado
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ViiV HealthcareTerminadoInfecciones por VIHEstados Unidos
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ViiV HealthcareGlaxoSmithKlineTerminadoInfecciones por VIH | Infección, Virus De La Inmunodeficiencia HumanaAlemania
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ViiV HealthcareGlaxoSmithKlineTerminadoInfección, Virus De La Inmunodeficiencia HumanaEstados Unidos
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Bristol-Myers SquibbTerminadoInsuficiencia cardiacaEstados Unidos
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