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

2018년 8월 20일 업데이트: 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.

연구 개요

상태

종료됨

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

210

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
의약품: BMS-955176
HIV 성숙 억제제
의약품: TDF/FTC
TDF/FTC
실험적: 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
의약품: BMS-955176
HIV 성숙 억제제
의약품: TDF/FTC
TDF/FTC
실험적: 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
의약품: BMS-955176
HIV 성숙 억제제
의약품: TDF/FTC
TDF/FTC
활성 비교기: 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
의약품: TDF/FTC
TDF/FTC
의약품: EFV
EFV

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

ViiV Healthcare

협력자

GlaxoSmithKline

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2015년 5월 12일

기본 완료 (실제)

2016년 5월 26일

연구 완료 (실제)

2017년 8월 21일

연구 등록 날짜

최초 제출

2015년 3월 11일

QC 기준을 충족하는 최초 제출

2015년 4월 9일

처음 게시됨 (추정)

2015년 4월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 9월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 8월 20일

마지막으로 확인됨

2018년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 205891
  • 2013-005487-26 (EudraCT 번호)
  • AI468-038 (기타 식별자: Bristol-Myers Squibb)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

BMS-955176에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Montenegro

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다