Clinical trial NCT02415595: Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Infection, Human Immunodeficiency Virus
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2015-04-14
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Week 24
Secondary outcomes:
measure: Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm
timeFrame: Weeks 48 and 96
measure: Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm
timeFrame: Week 24
measure: Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96
timeFrame: Weeks 48 and 96
measure: Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates
timeFrame: Week 24
measure: Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates
timeFrame: Week 24
measure: Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time
timeFrame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
measure: Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time
timeFrame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
measure: Change From Baseline in the Percentage of CD4+ T-cells Over Time
timeFrame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
measure: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD)
timeFrame: Up to Week 96
measure: Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events
timeFrame: Up to Week 96
measure: Maximum Observed Plasma Concentration (Cmax), Observed Pre-dose Plasma Concentration (C0) and Observed Plasma Concentration at the End of a Dosing Interval (Ctau) of BMS-955176/GSK3532795
timeFrame: Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
measure: Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795
timeFrame: Pre-dose (morning) and 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
measure: Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795
timeFrame: Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: DeLand
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Santa Fe
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: GSK Investigational Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Córdoba
country: Argentina
facility: GSK Investigational Site
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: GSK Investigational Site
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Santiago
country: Chile
facility: GSK Investigational Site
city: Santiago
country: Chile
facility: GSK Investigational Site
city: Le Kremlin-Bicêtre
country: France
facility: GSK Investigational Site
city: Lyon cedex 04
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Nice
country: France
facility: GSK Investigational Site
city: Paris Cedex 10
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Duesseldorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Dortmund
country: Germany
facility: GSK Investigational Site
city: Bergamo
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Monza
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Fracc. Las Americas
country: Mexico
facility: GSK Investigational Site
state: Aguascalientes
city: León
country: Mexico
facility: GSK Investigational Site
state: Guanajuato
city: DF
country: Mexico
facility: GSK Investigational Site
city: Durango
country: Mexico
facility: GSK Investigational Site
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Szczecin
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
state: Free State
city: Alcala de Henares
country: Spain
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
state: Midlothian
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Tooting, London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.