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

NCT ID: NCT02386098

Last Updated: 2018-08-20

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-08

Study Completion Date

2017-06-07

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

HIV Maturation Inhibitor

Atazanavir (ATV)

Intervention Type DRUG

Atazanavir

Ritonavir (RTV)

Intervention Type DRUG

Ritonavir

Dolutegravir (DTG)

Intervention Type DRUG

Dolutegravir

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

Group Type OTHER

Atazanavir (ATV)

Intervention Type DRUG

Atazanavir

Ritonavir (RTV)

Intervention Type DRUG

Ritonavir

Dolutegravir (DTG)

Intervention Type DRUG

Dolutegravir

Tenofovir (TDF)

Intervention Type DRUG

Tenofovir

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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

HIV Maturation Inhibitor

Atazanavir (ATV)

Intervention Type DRUG

Atazanavir

Dolutegravir (DTG)

Intervention Type DRUG

Dolutegravir

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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

HIV Maturation Inhibitor

Atazanavir (ATV)

Intervention Type DRUG

Atazanavir

Dolutegravir (DTG)

Intervention Type DRUG

Dolutegravir

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

Group Type OTHER

Atazanavir (ATV)

Intervention Type DRUG

Atazanavir

Ritonavir (RTV)

Intervention Type DRUG

Ritonavir

Dolutegravir (DTG)

Intervention Type DRUG

Dolutegravir

Tenofovir (TDF)

Intervention Type DRUG

Tenofovir

Interventions

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BMS-955176

HIV Maturation Inhibitor

Intervention Type DRUG

Atazanavir (ATV)

Atazanavir

Intervention Type DRUG

Ritonavir (RTV)

Ritonavir

Intervention Type DRUG

Dolutegravir (DTG)

Dolutegravir

Intervention Type DRUG

Tenofovir (TDF)

Tenofovir

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

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GSK Investigational Site

Beverly Hills, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Palm Springs, California, United States

Site Status

GSK Investigational Site

New Haven, Connecticut, United States

Site Status

GSK Investigational Site

DeLand, Florida, United States

Site Status

GSK Investigational Site

Fort Lauderdale, Florida, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

Site Status

GSK Investigational Site

Tampa, Florida, United States

Site Status

GSK Investigational Site

West Palm Beach, Florida, United States

Site Status

GSK Investigational Site

Atlanta, Georgia, United States

Site Status

GSK Investigational Site

Indianapolis, Indiana, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

The Bronx, New York, United States

Site Status

GSK Investigational Site

Tulsa, Oklahoma, United States

Site Status

GSK Investigational Site

Austin, Texas, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

Site Status

GSK Investigational Site

Buenos Aires, , Argentina

Site Status

GSK Investigational Site

Buenos Aires, , Argentina

Site Status

GSK Investigational Site

Córdoba, , Argentina

Site Status

GSK Investigational Site

Mar del Plata, , Argentina

Site Status

GSK Investigational Site

Darlinghurst, New South Wales, Australia

Site Status

GSK Investigational Site

Darlinghurst, Sydney, New South Wales, Australia

Site Status

GSK Investigational Site

Sydney, New South Wales, Australia

Site Status

GSK Investigational Site

Vancouver, British Columbia, Canada

Site Status

GSK Investigational Site

Vancouver, British Columbia, Canada

Site Status

GSK Investigational Site

Winnipeg, Manitoba, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Providencia, Santiago de Chile, , Chile

Site Status

GSK Investigational Site

Santiago, , Chile

Site Status

GSK Investigational Site

Barranquilla, , Colombia

Site Status

GSK Investigational Site

Bogotá, , Colombia

Site Status

GSK Investigational Site

Bogotá, , Colombia

Site Status

GSK Investigational Site

Cali, , Colombia

Site Status

GSK Investigational Site

Juárez, Chihuahua, Mexico

Site Status

GSK Investigational Site

Guadalajara, Jalisco, Mexico

Site Status

GSK Investigational Site

DF, , Mexico

Site Status

GSK Investigational Site

Distrito Federal, , Mexico

Site Status

GSK Investigational Site

Mexico City, , Mexico

Site Status

GSK Investigational Site

Mexico City, , Mexico

Site Status

GSK Investigational Site

Oaxaca City, , Mexico

Site Status

GSK Investigational Site

Lima, , Peru

Site Status

GSK Investigational Site

Lima, , Peru

Site Status

GSK Investigational Site

Lima, , Peru

Site Status

GSK Investigational Site

Lima, , Peru

Site Status

GSK Investigational Site

San Juan, , Puerto Rico

Site Status

GSK Investigational Site

Irkutsk, , Russia

Site Status

GSK Investigational Site

Krasnodar, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Yekaterinburg, , Russia

Site Status

GSK Investigational Site

Port Elizabeth, Eastern Cape, South Africa

Site Status

GSK Investigational Site

Bloemfontein, Free State, South Africa

Site Status

GSK Investigational Site

Tembisa, , South Africa

Site Status

GSK Investigational Site

Westdene, , South Africa

Site Status

GSK Investigational Site

Kaohsiung City, , Taiwan

Site Status

GSK Investigational Site

Taipei, , Taiwan

Site Status

GSK Investigational Site

Bangkok, , Thailand

Site Status

Countries

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United States Argentina Australia Canada Chile Colombia Mexico Peru Puerto Rico Russia South Africa Taiwan Thailand

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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AI468-048

Identifier Type: OTHER

Identifier Source: secondary_id

205892

Identifier Type: -

Identifier Source: org_study_id

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