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

NCT02415595 | Terminated Phase 2 Results

• 3 other identifiers: 2058912013-005487-26AI468-038
• Study Type: interventional
• Target: 210
• Locations: 12 countries
• Sites: 64

Brief Summary

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.

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• 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

  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

Secondary Outcomes (13)

• Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm

  Weeks 48 and 96

• Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm

  Week 24

• Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96

  Weeks 48 and 96

• Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates

  Week 24

• Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates

  Week 24

Study Arms (4)

Arm 1: BMS-955176 60 mg + TDF/FTC

EXPERIMENTAL

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; Drug: TDF/FTC

Arm 2: BMS-955176 120 mg + TDF/FTC

EXPERIMENTAL

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; Drug: TDF/FTC

Arm 3: BMS-955176 180 mg + TDF/FTC

EXPERIMENTAL

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; Drug: TDF/FTC

Arm 4: EFV + TDF/FTC

ACTIVE COMPARATOR

BMS-955176 placebo matching 60mg + BMS-955176 placebo matching 120mg + EFV at 600mg per day + TDF/FTC 300/200mg per day

Drug: EFV; Drug: TDF/FTC

Interventions

BMS-955176 DRUG

HIV Maturation Inhibitor

Arm 1: BMS-955176 60 mg + TDF/FTC; Arm 2: BMS-955176 120 mg + TDF/FTC; Arm 3: BMS-955176 180 mg + TDF/FTC

EFV DRUG

EFV

Arm 4: EFV + TDF/FTC

TDF/FTC DRUG

TDF/FTC

Arm 1: BMS-955176 60 mg + TDF/FTC; Arm 2: BMS-955176 120 mg + TDF/FTC; Arm 3: BMS-955176 180 mg + TDF/FTC; Arm 4: EFV + TDF/FTC

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-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

You may not qualify if:

• 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

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, 90036, United States

Location

GSK Investigational Site

DeLand, Florida, 32720, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30312, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Santa Fe, New Mexico, 87505, United States

Location

GSK Investigational Site

Tulsa, Oklahoma, 74135, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1181ACH, 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

Edmonton, Alberta, T6G 2G3, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

GSK Investigational Site

Ottawa, Ontario, K1H 8L6, 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, H3A 1T1, Canada

Location

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

Location

GSK Investigational Site

Québec, Quebec, G1V 4G2, Canada

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Location

GSK Investigational Site

Santiago, 7560994, Chile

Location

GSK Investigational Site

Santiago, 8360159, Chile

Location

GSK Investigational Site

Le Kremlin-Bicêtre, 94276, France

Location

GSK Investigational Site

Lyon, 69317, France

Location

GSK Investigational Site

Nantes, 44093, France

Location

GSK Investigational Site

Nice, 06202, France

Location

GSK Investigational Site

Paris, 75012, France

Location

GSK Investigational Site

Paris, 75013, France

Location

GSK Investigational Site

Paris, 75475, France

Location

GSK Investigational Site

Munich, Bavaria, 80335, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80336, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

GSK Investigational Site

Bonn, North Rhine-Westphalia, 53127, Germany

Location

GSK Investigational Site

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

GSK Investigational Site

Essen, North Rhine-Westphalia, 45122, Germany

Location

GSK Investigational Site

Berlin, 12157, Germany

Location

GSK Investigational Site

Berlin, 13353, Germany

Location

GSK Investigational Site

Dortmund, 44137, Germany

Location

GSK Investigational Site

Bergamo, Lombardy, 24127, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20127, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20157, Italy

Location

GSK Investigational Site

Monza, Lombardy, 20900, Italy

Location

GSK Investigational Site

Fracc. Las Americas, Aguascalientes, 20020, Mexico

Location

GSK Investigational Site

León, Guanajuato, 37000, Mexico

Location

GSK Investigational Site

DF, 14000, Mexico

Location

GSK Investigational Site

Durango, 34000, Mexico

Location

GSK Investigational Site

Mexico City, CP 14080, Mexico

Location

GSK Investigational Site

Bydgoszcz, 85-030, Poland

Location

GSK Investigational Site

Szczecin, 71-252, Poland

Location

GSK Investigational Site

Warsaw, 01-201, Poland

Location

GSK Investigational Site

Wroclaw, 50-220, Poland

Location

GSK Investigational Site

Bloemfontein, Free State, 9301, South Africa

Location

GSK Investigational Site

Alcalá de Henares, 28805, Spain

Location

GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15706, Spain

Location

GSK Investigational Site

Edinburgh, Midlothian, EH4 2XU, United Kingdom

Location

GSK Investigational Site

London, E1 1BB, United Kingdom

Location

GSK Investigational Site

London, SW10 9NH, United Kingdom

Location

GSK Investigational Site

London, W2 1NY, United Kingdom

Location

GSK Investigational Site

Tooting, London, SW17 0QT, United Kingdom

Location

Related Publications (1)

• Morales-Ramirez J, Bogner JR, Molina JM, Lombaard J, Dicker IB, Stock DA, DeGrosky M, Gartland M, Pene Dumitrescu T, Min S, Llamoso C, Joshi SR, Lataillade M. Safety, efficacy, and dose response of the maturation inhibitor GSK3532795 (formerly known as BMS-955176) plus tenofovir/emtricitabine once daily in treatment-naive HIV-1-infected adults: Week 24 primary analysis from a randomized Phase IIb trial. PLoS One. 2018 Oct 23;13(10):e0205368. doi: 10.1371/journal.pone.0205368. eCollection 2018.

  PMID: 30352054 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Interventions

BMS-955176

Condition Hierarchy (Ancestors)

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

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: April 14, 2015
• Study Start: May 12, 2015
• Primary Completion: May 26, 2016
• Study Completion: August 21, 2017
• Last Updated: September 19, 2018
• Results First Posted: September 19, 2018

Record last verified: 2018-08

Locations

FR (7); CA (8); IT (4); PL (4); ES (5); DE (9); CL (3); ME (5); GB (5); US (8); ZA (1); AR (5)