Clinical Trials

MainTitle

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

This study has been terminated
( The trial ended early due to GI intolerability and treatment-emergent resistance. )

Sponsor
ViiV Healthcare

Collaborator
GlaxoSmithKline

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02415595

First received: March 11, 2015
Last updated: October 9, 2017
Last Verified: October 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Infection, Human Immunodeficiency Virus

Drug : BMS-955176
Drug : EFV
Drug : TDF/FTC
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • Proportion of subjects taking BMS-955176 or EFV, each in combination with TDF/FTC, with plasma HIV-1 ribonucleic acid (RNA) < 40 c/mL at Week 24 [ Time Frame: Week 24 ]
Secondary Outcome Measures:
  • The antiviral efficacy of BMS-955176 and EFV by determining the proportion of subjects with plasma HIV-1 RNA < 40 c/mL [ Time Frame: At Weeks 48 and 96 ]
  • The antiviral efficacy of BMS-955176 and EFV by determining the proportion of subjects with plasma HIV-1 RNA < 200 c/mL [ Time Frame: At Weeks 24, 48 and 96 ]
  • The emergence of HIV drug resistance among samples selected for drug resistance testing will be assessed using the most recent version of the International AIDS Society (IAS)-USA list of HIV-1 drug resistance mutations [ Time Frame: At Weeks 24, 48 and 96 ]
    Samples meeting the criteria below will be selected for the drug resistance testing, and will tabulated by the number of unique subjects with mutations listed in the most recent version of the IAS-USA list of HIV-1 drug resistance mutations: Confirmed > 1 log10 c/mL increase in HIV-1 RNA at any time above nadir level where nadir is ≥ 40 c/mL HIV-1 RNA ≥ 40 c/mL if prior suppression < 40 c/mL Confirmed HIV-1 RNA ≥ 400 c/mL after Week 24 Failure to suppress last HIV-1 RNA to < 400 c/mL within Week 24, 48, or 96 week snapshot window
  • Safety and tolerability of BMS-955176 in treatment-naïve subjects by measuring frequency of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation [ Time Frame: At Weeks 24, 48 and 96 ]
  • Disease progression as measured by the occurrence of new AIDS defining events (CDC Class C events) [ Time Frame: At Weeks 24, 48 and 96 ]
  • Maximum observed plasma concentration (Cmax) of BMS-955176 [ Time Frame: At week 24 ]
  • Time of maximum observed plasma concentration (Tmax) of BMS-955176 [ Time Frame: At week 24 ]
  • Observed plasma concentration at the end of a dosing interval (Ctau) of BMS-955176 [ Time Frame: At week 24 ]
  • Observed pre-dose plasma concentration (C0) of BMS-955176 [ Time Frame: At week 24 ]
  • Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-955176 [ Time Frame: At week 24 ]
  • Efficacy: Mean changes from baseline in log10 HIV-1 RNA of BMS-955176 and EFV [ Time Frame: At Weeks 24, 48 and 96 ]
  • Efficacy: Mean changes in CD4+ T-cell counts of BMS-955176 and EFV [ Time Frame: At Weeks 24, 48 and 96 ]
  • Efficacy: Percentage of CD4+ T-cells of BMS-955176 and EFV [ Time Frame: At Weeks 24, 48 and 96 ]

Enrollment: 208
Study Start Date: May 12, 2015
Study Completion Date: August 21, 2017
Estimated Primary Completion Date: May 26, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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
Drug: BMS-955176

HIV Maturation Inhibitor

Drug: TDF/FTC

TDF/FTC

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
Drug: BMS-955176

HIV Maturation Inhibitor

Drug: TDF/FTC

TDF/FTC

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
Drug: BMS-955176

HIV Maturation Inhibitor

Drug: TDF/FTC

TDF/FTC

Active Comparator: 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
Drug: EFV

EFV

Drug: TDF/FTC

TDF/FTC

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02415595

Locations

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

Sponsors and Collaborators

ViiV Healthcare
GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information

Additional Information:

BMS clinical trial educational resource

Additional Information:

BMS Clinical Trial Information

Additional Information:

FDA Safety Alerts and Recalls

Additional Information:

Investigator Inquiry form

Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT02415595   History of Changes  
Other Study ID Numbers: 205891  
  2013-005487-26  
  AI468-038  
Study First Received: March 11, 2015  
Last Updated: October 9, 2017  

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Emtricitabine

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.