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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02386098




Registration number
NCT02386098
Ethics application status
Date submitted
6/03/2015
Date registered
11/03/2015
Date last updated
20/08/2018

Titles & IDs
Public title
Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults
Scientific title
A Phase 2b Randomized, Active-Controlled, Staged, Open-Label Trial to Investigate Safety and Efficacy of BMS-955176/GSK3532795 in Combination With Dolutegravir and Atazanavir (With or Without Ritonavir) in Treatment-Experienced HIV-1 Infected Adults
Secondary ID [1] 0 0
AI468-048
Secondary ID [2] 0 0
205892
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-955176
Treatment: Drugs - Atazanavir (ATV)
Treatment: Drugs - Ritonavir (RTV)
Treatment: Drugs - Dolutegravir (DTG)
Treatment: Drugs - Tenofovir (TDF)

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

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

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

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

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


Treatment: Drugs: BMS-955176
HIV Maturation Inhibitor

Treatment: Drugs: Atazanavir (ATV)
Atazanavir

Treatment: Drugs: Ritonavir (RTV)
Ritonavir

Treatment: Drugs: Dolutegravir (DTG)
Dolutegravir

Treatment: Drugs: Tenofovir (TDF)
Tenofovir
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24-Stage 1
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Week 24-Stage 2
Timepoint [2] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1
Timepoint [1] 0 0
Weeks 48 and 96
Secondary outcome [2] 0 0
Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 2
Timepoint [2] 0 0
Weeks 48 and 96
Secondary outcome [3] 0 0
Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1
Timepoint [3] 0 0
Weeks 24, 48 and 96
Secondary outcome [4] 0 0
Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 2
Timepoint [4] 0 0
Weeks 24, 48 and 96
Secondary outcome [5] 0 0
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1
Timepoint [5] 0 0
Baseline and up to Week 72
Secondary outcome [6] 0 0
Change From Baseline in log10 HIV-1 RNA Over Time-Stage 2
Timepoint [6] 0 0
Baseline and up to Week 96
Secondary outcome [7] 0 0
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1
Timepoint [7] 0 0
Baseline and up to Week 72
Secondary outcome [8] 0 0
Change From Baseline in CD4+ Cell Count Over Time-Stage 2
Timepoint [8] 0 0
Baseline and up to Week 96
Secondary outcome [9] 0 0
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1
Timepoint [9] 0 0
Baseline and up to Week 72
Secondary outcome [10] 0 0
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 2
Timepoint [10] 0 0
Baseline and up to Week 96
Secondary outcome [11] 0 0
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1
Timepoint [11] 0 0
Up to Week 96
Secondary outcome [12] 0 0
Number of Participants With SAEs and AELDs-Stage 2
Timepoint [12] 0 0
Up to Week 96
Secondary outcome [13] 0 0
Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1
Timepoint [13] 0 0
Up to Week 96
Secondary outcome [14] 0 0
Number of Participants With Occurrence of New AIDS Defining Events-Stage 2
Timepoint [14] 0 0
Up to Week 96
Secondary outcome [15] 0 0
Maximum Observed Concentration (Cmax) for BMS-955176-Stage 1
Timepoint [15] 0 0
Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Secondary outcome [16] 0 0
Cmax for BMS-955176-Stage 2
Timepoint [16] 0 0
Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Secondary outcome [17] 0 0
Time of Maximum Observed Plasma Concentration (Tmax) for BMS-955176-Stage 1
Timepoint [17] 0 0
Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Secondary outcome [18] 0 0
Tmax for BMS-955176-Stage 2
Timepoint [18] 0 0
Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Secondary outcome [19] 0 0
Observed Plasma Concentration at the End of a Dosing Interval (Ctau) for BMS-955176-Stage 1
Timepoint [19] 0 0
Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Secondary outcome [20] 0 0
Ctau for BMS-955176-Stage 2
Timepoint [20] 0 0
Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Secondary outcome [21] 0 0
Observed Pre-dose Plasma Concentration (C0) for BMS-955176-Stage 1
Timepoint [21] 0 0
Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Secondary outcome [22] 0 0
C0 for BMS-955176-Stage 2
Timepoint [22] 0 0
Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Secondary outcome [23] 0 0
Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) for BMS-955176-Stage 1
Timepoint [23] 0 0
Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Secondary outcome [24] 0 0
AUC(Tau) for BMS-955176-Stage 2
Timepoint [24] 0 0
Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Secondary outcome [25] 0 0
Number of Participants With Emergence of HIV Drug Resistance-Stage 1
Timepoint [25] 0 0
Up to Week 96
Secondary outcome [26] 0 0
Number of Participants With Emergence of HIV Drug Resistance-Stage 2
Timepoint [26] 0 0
Up to Week 96

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/06/2017
Sample size
Target
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst, Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
GSK Investigational Site - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst, Sydney
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Santa Fe
Country [11] 0 0
Argentina
State/province [11] 0 0
Córdoba
Country [12] 0 0
Argentina
State/province [12] 0 0
Mar del Plata
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Manitoba
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Chile
State/province [17] 0 0
Región Metro De Santiago
Country [18] 0 0
Chile
State/province [18] 0 0
Providencia, Santiago De Chile
Country [19] 0 0
Chile
State/province [19] 0 0
Santiago
Country [20] 0 0
Colombia
State/province [20] 0 0
Barranquilla
Country [21] 0 0
Colombia
State/province [21] 0 0
Bogota
Country [22] 0 0
Colombia
State/province [22] 0 0
Bogotá
Country [23] 0 0
Colombia
State/province [23] 0 0
Cali
Country [24] 0 0
Mexico
State/province [24] 0 0
Chihuahua
Country [25] 0 0
Mexico
State/province [25] 0 0
Jalisco
Country [26] 0 0
Mexico
State/province [26] 0 0
DF
Country [27] 0 0
Mexico
State/province [27] 0 0
Distrito Federal
Country [28] 0 0
Mexico
State/province [28] 0 0
Mexico City
Country [29] 0 0
Mexico
State/province [29] 0 0
Oaxaca
Country [30] 0 0
Peru
State/province [30] 0 0
Lima
Country [31] 0 0
Puerto Rico
State/province [31] 0 0
San Juan
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Ekaterinburg
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Irkutsk
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Krasnodar
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Moscow
Country [36] 0 0
Russian Federation
State/province [36] 0 0
St. Petersburg
Country [37] 0 0
South Africa
State/province [37] 0 0
Eastern Cape
Country [38] 0 0
South Africa
State/province [38] 0 0
Free State
Country [39] 0 0
South Africa
State/province [39] 0 0
Tembisa
Country [40] 0 0
South Africa
State/province [40] 0 0
Westdene
Country [41] 0 0
Taiwan
State/province [41] 0 0
Kaohsiung
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taipei
Country [43] 0 0
Thailand
State/province [43] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ViiV Healthcare
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02386098
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
ViiV Healthcare
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02386098