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Clinical Trials

MainTitle

Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults

This study has been terminated
( The trial ended early due to GI intolerability. )

Sponsor
ViiV Healthcare

Collaborator
GlaxoSmithKline

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02386098

First received: March 6, 2015
Last updated: September 25, 2017
Last Verified: September 2017
History of Changes
Purpose

Purpose

The purpose of this study is to evaluate whether the combination of BMS-955176 with atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious, safe, and well-tolerated in HIV-1 infected treatment experienced adults.

Condition Intervention Phase
Infection, Human Immunodeficiency Virus

Drug : BMS-955176
Drug : Atazanavir (ATV)
Drug : Ritonavir (RTV)
Drug : Dolutegravir (DTG)
Drug : Tenofovir (TDF)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2b Randomized, Active-Controlled, Staged, Open-label Trial to Investigate Safety and Efficacy of BMS-955176 in Combination With Dolutegravir and Atazanavir (With or Without Ritonavir) in Treatment-Experienced HIV-1 Infected Adults

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • The proportion of subjects with plasma HIV 1 RNA less than 40 c/mL at Week 24 [ Time Frame: Week 24 ]
Secondary Outcome Measures:
  • The antiviral efficacy of BMS-955176 Arms, and the TDF-containing Arms (TDF + ATV/r + DTG), by determining the proportion of treatment-experienced subjects with plasma HIV-1 RNA less than 40 c/mL [ Time Frame: At Weeks 48 and 96 ]
  • The antiviral efficacy of BMS-955176 Arms, and the TDF-containing Arms, by determining the proportion of treatment-experienced subjects with plasma HIV-1 RNA less than 200 c/mL [ Time Frame: At Weeks 24,48 and 96 ]
  • The emergence of HIV drug resistance in samples selected for drug resistance testing [ Time Frame: At Weeks 24,48 and 96 ]
  • Efficacy of BMS-955176 Arms, and the TDF-containing Arms, by using the mean changes from baseline in log10 HIV-1 RNA, CD4+ T-cell counts, and percentage of CD4+ T cells [ Time Frame: At Weeks 24,48 and 96 ]
  • Safety and tolerability of BMS-955176 in treatment-experienced 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 Acquired immune deficiency syndrome (AIDS) defining events (CDC Class C events) [ Time Frame: At Weeks 24,48 and 96 ]
  • Area under the concentration-time curve (AUC) of BMS-955176 [ Time Frame: At Week 24 ]
  • Maximum observed concentration (Cmax) of BMS-955176 [ Time Frame: At Week 24 ]

Enrollment: 84
Study Start Date: July 8, 2015
Study Completion Date: June 7, 2017
Estimated Primary Completion Date: June 7, 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Arm 1: BMS-955176 + ATV + RTV + DTG
BMS-955176 at 120 mg tablet per day + Atazanavir boosted with ritonavir (ATV/r) 300/100 mg tablets per day + DTG 50 mg tablet per day, orally
Drug: BMS-955176

HIV Maturation Inhibitor

Drug: Atazanavir (ATV)

Atazanavir

Drug: Ritonavir (RTV)

Ritonavir

Drug: Dolutegravir (DTG)

Dolutegravir

Other: Arm 2: TDF + ATV + RTV + DTG
TDF 300 mg tablet per day + ATV/r at 300/100 mg tablets per day + DTG 50 mg per day, orally
Drug: Atazanavir (ATV)

Atazanavir

Drug: Ritonavir (RTV)

Ritonavir

Drug: Dolutegravir (DTG)

Dolutegravir

Drug: Tenofovir (TDF)

Tenofovir

Experimental: Arm 3: BMS-955176 + ATV + DTG
BMS-955176 at 120 mg tablet per day + ATV at 400 mg tablet per day + DTG at 50 mg tablet per day, orally
Drug: BMS-955176

HIV Maturation Inhibitor

Drug: Atazanavir (ATV)

Atazanavir

Drug: Dolutegravir (DTG)

Dolutegravir

Experimental: Arm 4: BMS-955176 + ATV + DTG
BMS-955176 at 180 mg tablet per day + ATV at 400 mg tablet per day + DTG at 50 mg tablet per day, orally
Drug: BMS-955176

HIV Maturation Inhibitor

Drug: Atazanavir (ATV)

Atazanavir

Drug: Dolutegravir (DTG)

Dolutegravir

Other: Arm 5: TDF + ATV + RTV + DTG
TDF 300 mg tablet per day + ATV/r at 300/100 mg tablets per day + DTG 50 mg per day, orally
Drug: Atazanavir (ATV)

Atazanavir

Drug: Ritonavir (RTV)

Ritonavir

Drug: Dolutegravir (DTG)

Dolutegravir

Drug: Tenofovir (TDF)

Tenofovir

Eligibility

Eligibility

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

Criteria

Inclusion Criteria:

  • Men and non-pregnant women, at least 18 years of age
  • Antiretroviral treatment-experienced, defined as having documented evidence of having failed 1 or 2 regimens that include 2 or 3 classes of antiretroviral (ARV) (with or without documented resistance)
  • CD4+ T-cell count > 50 cells/mm3
  • Screening genotype/phenotype indicating susceptibility to study drugs (unboosted ATV, FC < 2.2; DTG; TDF)


Exclusion Criteria:
  • Antiretroviral treatment-experienced adults who have failed > 2 ARV regimens
  • Resistance or partial resistance to any study drug determined by tests at Screening
  • Historical or documented genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to ATV, TDF, RAL, Protease Inhibitors, and certain TAMs
  • 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: NCT02386098

Locations

United States, California
GSK Investigational Site
Beverly Hills, California, United States, 90211
GSK Investigational Site
Palm Springs, California, United States, 92262
GSK Investigational Site
Pasadena, California, United States, 91101
United States, Connecticut
GSK Investigational Site
New Haven, Connecticut, United States, 06520
United States, Florida
GSK Investigational Site
DeLand, Florida, United States, 32720
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Tampa, Florida, United States, 33614
GSK Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30312
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, New York
GSK Investigational Site
New York, New York, United States, 10029
GSK Investigational Site
The Bronx, New York, United States, 10467
United States, Oklahoma
GSK Investigational Site
Tulsa, Oklahoma, United States, 74135
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
GSK Investigational Site
Dallas, Texas, United States, 75246
Argentina
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1405CKC
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
GSK Investigational Site
Mar del Plata, Argentina, B7600FZN
Australia
GSK Investigational Site
Darlinghurst, Sydney, New South Wales, Australia, 2010
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
GSK Investigational Site
Sydney, New South Wales, Australia, 2010
Canada
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y6
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 2C7
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3A 1R9
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2N2
GSK Investigational Site
Montreal, Quebec, Canada, H2L 4P9
GSK Investigational Site
Montreal, Quebec, Canada, H2L 5B1
GSK Investigational Site
Montreal, Quebec, Canada, H4A 3J1
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 8330074
GSK Investigational Site
Providencia, Santiago de Chile, Chile, 7500922
GSK Investigational Site
Santiago, Chile, 8360159
Colombia
GSK Investigational Site
Barranquilla, Colombia
GSK Investigational Site
Bogota, Colombia, 111311
GSK Investigational Site
Bogotá, Colombia
GSK Investigational Site
Cali, Colombia
Mexico
GSK Investigational Site
Juarez, Chihuahua, Mexico, 32330
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44280
GSK Investigational Site
DF, Mexico, 14000
GSK Investigational Site
Distrito Federal, Mexico, 03720
GSK Investigational Site
Mexico City, Mexico, 06700
GSK Investigational Site
Mexico City, Mexico, CP 14080
GSK Investigational Site
Oaxaca, Mexico, 68000
Peru
GSK Investigational Site
Lima, Peru, 1
GSK Investigational Site
Lima, Peru, Lima 11
GSK Investigational Site
Lima, Peru, Lima 14
GSK Investigational Site
Lima, Peru, Lima 31
Puerto Rico
GSK Investigational Site
San Juan, Puerto Rico, 00909-1711
Russian Federation
GSK Investigational Site
Ekaterinburg, Russian Federation, 620102
GSK Investigational Site
Irkutsk, Russian Federation, 664035
GSK Investigational Site
Krasnodar, Russian Federation, 350015
GSK Investigational Site
Moscow, Russian Federation, 105275
GSK Investigational Site
St. Petersburg, Russian Federation, 190103
South Africa
GSK Investigational Site
Port Elizabeth, Eastern Cape, South Africa, 6001
GSK Investigational Site
Bloemfontein, Free State, South Africa, 9301
GSK Investigational Site
Tembisa, South Africa, 1632
GSK Investigational Site
Westdene, South Africa, 2092
Taiwan
GSK Investigational Site
Kaohsiung, Taiwan, 81346
GSK Investigational Site
Taipei, Taiwan, 100
Thailand
GSK Investigational Site
Bangkok, Thailand, 10330

Sponsors and Collaborators

ViiV Healthcare
GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT02386098   History of Changes  
Other Study ID Numbers: 205892  
  AI468-048  
Study First Received: March 6, 2015  
Last Updated: September 25, 2017  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Ritonavir
Atazanavir Sulfate
Tenofovir
Dolutegravir

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.