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

NCT02386098 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 205892AI468-048
• Study Type: interventional
• Target: 86
• Locations: 13 countries
• Sites: 64

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• 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

  Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA \<40 c/mL at Week 24 was assessed using the Food and Drug Administration (FDA) snapshot algorithm which 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 the modified intent to treat (mITT) Population which comprised of all randomized participants who received atleast one dose of BMS-955176 or TDF.

  Week 24

• Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Week 24-Stage 2

  Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the study during Stage 1.

  Week 24

Secondary Outcomes (26)

• Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1

  Weeks 48 and 96

• Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 2

  Weeks 48 and 96

• Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1

  Weeks 24, 48 and 96

• Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 2

  Weeks 24, 48 and 96

• Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1

  Baseline and up to Week 72

Study Arms (5)

Arm 1: BMS-955176 + ATV + RTV + DTG

EXPERIMENTAL

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; Drug: Atazanavir (ATV); Drug: Ritonavir (RTV); Drug: Dolutegravir (DTG)

Arm 2: TDF + ATV + RTV + DTG

OTHER

TDF 300 mg tablet per day + ATV/r at 300/100 mg tablets per day + DTG 50 mg per day, orally

Drug: Atazanavir (ATV); Drug: Ritonavir (RTV); Drug: Dolutegravir (DTG); Drug: Tenofovir (TDF)

Arm 3: BMS-955176 + ATV + DTG

EXPERIMENTAL

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; Drug: Atazanavir (ATV); Drug: Dolutegravir (DTG)

Arm 4: BMS-955176 + ATV + DTG

EXPERIMENTAL

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; Drug: Atazanavir (ATV); Drug: Dolutegravir (DTG)

Arm 5: TDF + ATV + RTV + DTG

OTHER

TDF 300 mg tablet per day + ATV/r at 300/100 mg tablets per day + DTG 50 mg per day, orally

Drug: Atazanavir (ATV); Drug: Ritonavir (RTV); Drug: Dolutegravir (DTG); Drug: Tenofovir (TDF)

Interventions

BMS-955176 DRUG

HIV Maturation Inhibitor

Arm 1: BMS-955176 + ATV + RTV + DTG; Arm 3: BMS-955176 + ATV + DTG; Arm 4: BMS-955176 + ATV + DTG

Atazanavir (ATV) DRUG

Atazanavir

Arm 1: BMS-955176 + ATV + RTV + DTG; Arm 2: TDF + ATV + RTV + DTG; Arm 3: BMS-955176 + ATV + DTG; Arm 4: BMS-955176 + ATV + DTG; Arm 5: TDF + ATV + RTV + DTG

Ritonavir (RTV) DRUG

Ritonavir

Arm 1: BMS-955176 + ATV + RTV + DTG; Arm 2: TDF + ATV + RTV + DTG; Arm 5: TDF + ATV + RTV + DTG

Dolutegravir (DTG) DRUG

Dolutegravir

Arm 1: BMS-955176 + ATV + RTV + DTG; Arm 2: TDF + ATV + RTV + DTG; Arm 3: BMS-955176 + ATV + DTG; Arm 4: BMS-955176 + ATV + DTG; Arm 5: TDF + ATV + RTV + DTG

Tenofovir (TDF) DRUG

Tenofovir

Arm 2: TDF + ATV + RTV + DTG; Arm 5: TDF + ATV + RTV + DTG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

Study Sites (64)

GSK Investigational Site

Beverly Hills, California, 90211, United States

Location

GSK Investigational Site

Los Angeles, California, 90027, United States

Location

GSK Investigational Site

Palm Springs, California, 92262, United States

Location

GSK Investigational Site

New Haven, Connecticut, 06520, United States

Location

GSK Investigational Site

DeLand, Florida, 32720, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Orlando, Florida, 32804, United States

Location

GSK Investigational Site

Tampa, Florida, 33614, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33401, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30312, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

New York, New York, 10029, United States

Location

GSK Investigational Site

The Bronx, New York, 10467, United States

Location

GSK Investigational Site

Tulsa, Oklahoma, 74135, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1405CKC, Argentina

Location

GSK Investigational Site

Rosario, Santa Fe Province, 2000, Argentina

Location

GSK Investigational Site

Buenos Aires, 1141, Argentina

Location

GSK Investigational Site

Buenos Aires, 1202, Argentina

Location

GSK Investigational Site

Córdoba, X5000JJS, Argentina

Location

GSK Investigational Site

Mar del Plata, B7600FZN, Argentina

Location

GSK Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

GSK Investigational Site

Darlinghurst, Sydney, New South Wales, 2010, Australia

Location

GSK Investigational Site

Sydney, New South Wales, 2010, Australia

Location

GSK Investigational Site

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

GSK Investigational Site

Vancouver, British Columbia, V6Z 2C7, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

GSK Investigational Site

Toronto, Ontario, M4N 3M5, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 2N2, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 5B1, Canada

Location

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 8330074, Chile

Location

GSK Investigational Site

Providencia, Santiago de Chile, 7500922, Chile

Location

GSK Investigational Site

Santiago, 8360159, Chile

Location

GSK Investigational Site

Barranquilla, Colombia

Location

GSK Investigational Site

Bogotá, 111311, Colombia

Location

GSK Investigational Site

Bogotá, Colombia

Location

GSK Investigational Site

Cali, Colombia

Location

GSK Investigational Site

Juárez, Chihuahua, 32330, Mexico

Location

GSK Investigational Site

Guadalajara, Jalisco, 44280, Mexico

Location

GSK Investigational Site

DF, 14000, Mexico

Location

GSK Investigational Site

Distrito Federal, 03720, Mexico

Location

GSK Investigational Site

Mexico City, 06700, Mexico

Location

GSK Investigational Site

Mexico City, CP 14080, Mexico

Location

GSK Investigational Site

Oaxaca City, 68000, Mexico

Location

GSK Investigational Site

Lima, 1, Peru

Location

GSK Investigational Site

Lima, Lima 11, Peru

Location

GSK Investigational Site

Lima, Lima 14, Peru

Location

GSK Investigational Site

Lima, Lima 31, Peru

Location

GSK Investigational Site

San Juan, 00909-1711, Puerto Rico

Location

GSK Investigational Site

Irkutsk, 664035, Russia

Location

GSK Investigational Site

Krasnodar, 350015, Russia

Location

GSK Investigational Site

Moscow, 105275, Russia

Location

GSK Investigational Site

Saint Petersburg, 190103, Russia

Location

GSK Investigational Site

Yekaterinburg, 620102, Russia

Location

GSK Investigational Site

Port Elizabeth, Eastern Cape, 6001, South Africa

Location

GSK Investigational Site

Bloemfontein, Free State, 9301, South Africa

Location

GSK Investigational Site

Tembisa, 1632, South Africa

Location

GSK Investigational Site

Westdene, 2092, South Africa

Location

GSK Investigational Site

Kaohsiung City, 81346, Taiwan

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

GSK Investigational Site

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

HIV Infections

Interventions

BMS-955176; Atazanavir Sulfate; Ritonavir; dolutegravir; Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Organophosphonates; Organophosphorus Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 11, 2015
• Study Start: July 8, 2015
• Primary Completion: June 7, 2017
• Study Completion: June 7, 2017
• Last Updated: August 20, 2018
• Results First Posted: August 20, 2018

Record last verified: 2018-08

Locations

TH (1); US (16); AR (6); CO (4); AU (3); ME (7); ZA (4); CL (3); PR (1); TW (2); RU (5); PE (4); CA (8)