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Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults

20 августа 2018 г. обновлено: 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.

Обзор исследования

Статус

Прекращено

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

210

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Аргентина
      • Buenos Aires, Аргентина, 1141
        • GSK Investigational Site
      • Buenos Aires, Аргентина, 1202
        • GSK Investigational Site
      • Córdoba, Аргентина, X5000JJS
        • GSK Investigational Site
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Аргентина, C1181ACH
        • GSK Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Аргентина, 2000
        • GSK Investigational Site
  • Германия
      • Berlin, Германия, 13353
        • GSK Investigational Site
      • Berlin, Германия, 12157
        • GSK Investigational Site
      • Dortmund, Германия, 44137
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Германия, 80335
        • GSK Investigational Site
      • Muenchen, Bayern, Германия, 80336
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Германия, 30625
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Германия, 53127
        • GSK Investigational Site
      • Duesseldorf, Nordrhein-Westfalen, Германия, 40225
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Германия, 45122
        • GSK Investigational Site
  • Испания
      • Alcala de Henares, Испания, 28805
        • GSK Investigational Site
      • Badalona, Испания, 08916
        • GSK Investigational Site
      • Madrid, Испания, 28040
        • GSK Investigational Site
      • Madrid, Испания, 28034
        • GSK Investigational Site
      • Santiago de Compostela, Испания, 15706
        • GSK Investigational Site
  • Италия
    • Lombardia
      • Bergamo, Lombardia, Италия, 24127
        • GSK Investigational Site
      • Milano, Lombardia, Италия, 20127
        • GSK Investigational Site
      • Milano, Lombardia, Италия, 20157
        • GSK Investigational Site
      • Monza, Lombardia, Италия, 20900
        • GSK Investigational Site
  • Канада
      • Quebec, Канада, G1V 4G2
        • GSK Investigational Site
    • Alberta
      • Edmonton, Alberta, Канада, T6G 2G3
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Канада, R3A 1R9
        • GSK Investigational Site
    • Ontario
      • Ottawa, Ontario, Канада, K1H 8L6
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Канада, H3A 1T1
        • GSK Investigational Site
      • Montreal, Quebec, Канада, H2L 4P9
        • GSK Investigational Site
      • Montreal, Quebec, Канада, H4A 3J1
        • GSK Investigational Site
      • Montreal, Quebec, Канада, H2L 5B1
        • GSK Investigational Site
  • Мексика
      • DF, Мексика, 14000
        • GSK Investigational Site
      • Durango, Мексика, 34000
        • GSK Investigational Site
      • Mexico City, Мексика, CP 14080
        • GSK Investigational Site
    • Aguascalientes
      • Fracc. Las Americas, Aguascalientes, Мексика, 20020
        • GSK Investigational Site
    • Guanajuato
      • León, Guanajuato, Мексика, 37000
        • GSK Investigational Site
  • Польша
      • Bydgoszcz, Польша, 85-030
        • GSK Investigational Site
      • Szczecin, Польша, 71-252
        • GSK Investigational Site
      • Warszawa, Польша, 01-201
        • GSK Investigational Site
      • Wroclaw, Польша, 50-220
        • GSK Investigational Site
  • Соединенное Королевство
      • London, Соединенное Королевство, E1 1BB
        • GSK Investigational Site
      • London, Соединенное Королевство, W2 1NY
        • GSK Investigational Site
      • London, Соединенное Королевство, SW10 9NH
        • GSK Investigational Site
      • Tooting, London, Соединенное Королевство, SW17 0QT
        • GSK Investigational Site
    • Midlothian
      • Edinburgh, Midlothian, Соединенное Королевство, EH4 2XU
        • GSK Investigational Site
  • Соединенные Штаты
    • California
      • Beverly Hills, California, Соединенные Штаты, 90211
        • GSK Investigational Site
      • Los Angeles, California, Соединенные Штаты, 90036
        • GSK Investigational Site
    • Florida
      • DeLand, Florida, Соединенные Штаты, 32720
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Соединенные Штаты, 30312
        • GSK Investigational Site
      • Decatur, Georgia, Соединенные Штаты, 30033
        • GSK Investigational Site
    • New Mexico
      • Santa Fe, New Mexico, Соединенные Штаты, 87505
        • GSK Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, Соединенные Штаты, 74135
        • GSK Investigational Site
    • Texas
      • Fort Worth, Texas, Соединенные Штаты, 76104
        • GSK Investigational Site
  • Франция
      • Le Kremlin-Bicêtre, Франция, 94276
        • GSK Investigational Site
      • Lyon cedex 04, Франция, 69317
        • GSK Investigational Site
      • Nantes, Франция, 44093
        • GSK Investigational Site
      • Nice, Франция, 06202
        • GSK Investigational Site
      • Paris, Франция, 75013
        • GSK Investigational Site
      • Paris, Франция, 75012
        • GSK Investigational Site
      • Paris Cedex 10, Франция, 75475
        • GSK Investigational Site
  • Чили
      • Santiago, Чили, 8360159
        • GSK Investigational Site
      • Santiago, Чили, 7560994
        • GSK Investigational Site
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Чили
        • GSK Investigational Site
  • Южная Африка
    • Free State
      • Bloemfontein, Free State, Южная Африка, 9301
        • GSK Investigational Site

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Тройной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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
Лекарство: БМС-955176
Ингибитор созревания ВИЧ
Лекарство: TDF/FTC
TDF/FTC
Экспериментальный: 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
Лекарство: БМС-955176
Ингибитор созревания ВИЧ
Лекарство: TDF/FTC
TDF/FTC
Экспериментальный: 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
Лекарство: БМС-955176
Ингибитор созревания ВИЧ
Лекарство: TDF/FTC
TDF/FTC
Активный компаратор: 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
Лекарство: TDF/FTC
TDF/FTC
Лекарство: EFV
EFV

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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
Временное ограничение: Week 24
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.
Week 24

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm
Временное ограничение: Weeks 48 and 96
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).
Weeks 48 and 96
Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm
Временное ограничение: Week 24
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.
Week 24
Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96
Временное ограничение: Weeks 48 and 96
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).
Weeks 48 and 96
Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates
Временное ограничение: Week 24
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.
Week 24
Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates
Временное ограничение: Week 24
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.
Week 24
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time
Временное ограничение: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
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.
Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time
Временное ограничение: Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
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.
Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Change From Baseline in the Percentage of CD4+ T-cells Over Time
Временное ограничение: Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
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.
Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD)
Временное ограничение: Up to Week 96
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.
Up to Week 96
Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events
Временное ограничение: Up to Week 96
The occurrence of new AIDS defining events that is CDC class C events is presented.
Up to Week 96
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
Временное ограничение: 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)
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.
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)
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795
Временное ограничение: 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)
Serial blood samples were collected at indicated time points for intensive PK assessment.
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)
Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795
Временное ограничение: 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)
Serial blood samples were collected at indicated time points for intensive PK assessment.
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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

ViiV Healthcare

Соавторы

GlaxoSmithKline

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

12 мая 2015 г.

Первичное завершение (Действительный)

26 мая 2016 г.

Завершение исследования (Действительный)

21 августа 2017 г.

Даты регистрации исследования

Первый отправленный

11 марта 2015 г.

Впервые представлено, что соответствует критериям контроля качества

9 апреля 2015 г.

Первый опубликованный (Оценивать)

14 апреля 2015 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

19 сентября 2018 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

20 августа 2018 г.

Последняя проверка

1 августа 2018 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 205891
  • 2013-005487-26 (Номер EudraCT)
  • AI468-038 (Другой идентификатор: Bristol-Myers Squibb)

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования БМС-955176

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