MedDataX Logo

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

NCT ID: NCT02415595

Last Updated: 2018-09-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-12

Study Completion Date

2017-08-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults

NCT01565850

Acquired Immunodeficiency Syndrome HIV Infections
COMPLETED PHASE2

A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects

NCT02431247

Immunodeficiency Virus Type 1, Human
COMPLETED PHASE3

Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF

NCT02121795

HIV-1 Infection
COMPLETED PHASE3

A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults

NCT04493216

HIV Infections
TERMINATED PHASE2

A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy

NCT05917509

HIV Infections
ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infection, Human Immunodeficiency Virus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

HIV Maturation Inhibitor

TDF/FTC

Intervention Type DRUG

TDF/FTC

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

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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

HIV Maturation Inhibitor

TDF/FTC

Intervention Type DRUG

TDF/FTC

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

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

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

HIV Maturation Inhibitor

TDF/FTC

Intervention Type DRUG

TDF/FTC

Arm 4: EFV + TDF/FTC

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

Group Type ACTIVE_COMPARATOR

EFV

Intervention Type DRUG

EFV

TDF/FTC

Intervention Type DRUG

TDF/FTC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-955176

HIV Maturation Inhibitor

Intervention Type DRUG

EFV

EFV

Intervention Type DRUG

TDF/FTC

TDF/FTC

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Beverly Hills, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

DeLand, Florida, United States

Site Status

GSK Investigational Site

Atlanta, Georgia, United States

Site Status

GSK Investigational Site

Decatur, Georgia, United States

Site Status

GSK Investigational Site

Santa Fe, New Mexico, United States

Site Status

GSK Investigational Site

Tulsa, Oklahoma, United States

Site Status

GSK Investigational Site

Fort Worth, Texas, United States

Site Status

GSK Investigational Site

Ciudad Autonoma 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

Edmonton, Alberta, Canada

Site Status

GSK Investigational Site

Winnipeg, Manitoba, Canada

Site Status

GSK Investigational Site

Ottawa, 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

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Québec, Quebec, Canada

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Santiago, , Chile

Site Status

GSK Investigational Site

Santiago, , Chile

Site Status

GSK Investigational Site

Le Kremlin-Bicêtre, , France

Site Status

GSK Investigational Site

Lyon, , France

Site Status

GSK Investigational Site

Nantes, , France

Site Status

GSK Investigational Site

Nice, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Hanover, Lower Saxony, Germany

Site Status

GSK Investigational Site

Bonn, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Dortmund, , Germany

Site Status

GSK Investigational Site

Bergamo, Lombardy, Italy

Site Status

GSK Investigational Site

Milan, Lombardy, Italy

Site Status

GSK Investigational Site

Milan, Lombardy, Italy

Site Status

GSK Investigational Site

Monza, Lombardy, Italy

Site Status

GSK Investigational Site

Fracc. Las Americas, Aguascalientes, Mexico

Site Status

GSK Investigational Site

León, Guanajuato, Mexico

Site Status

GSK Investigational Site

DF, , Mexico

Site Status

GSK Investigational Site

Durango, , Mexico

Site Status

GSK Investigational Site

Mexico City, , Mexico

Site Status

GSK Investigational Site

Bydgoszcz, , Poland

Site Status

GSK Investigational Site

Szczecin, , Poland

Site Status

GSK Investigational Site

Warsaw, , Poland

Site Status

GSK Investigational Site

Wroclaw, , Poland

Site Status

GSK Investigational Site

Bloemfontein, Free State, South Africa

Site Status

GSK Investigational Site

Alcalá de Henares, , Spain

Site Status

GSK Investigational Site

Badalona, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Santiago de Compostela, , Spain

Site Status

GSK Investigational Site

Edinburgh, Midlothian, United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

Tooting, London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Canada Chile France Germany Italy Mexico Poland South Africa Spain United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30352054 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-005487-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AI468-038

Identifier Type: OTHER

Identifier Source: secondary_id

205891

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
NCT01968551 COMPLETED PHASE3
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF
NCT01252940 COMPLETED PHASE3
A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects
NCT00951015 COMPLETED PHASE2
Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
NCT02269917 COMPLETED PHASE3
Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients
NCT01019551 COMPLETED PHASE2
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
NCT06101342 ACTIVE_NOT_RECRUITING PHASE2
Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
NCT03405935 COMPLETED PHASE3
National Multicenter Trial Evaluating Two Treatments in Patients with Primary Human Immunodeficiency Virus (HIV-1) Infection
NCT02987530 COMPLETED PHASE3
A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment
NCT01709084 COMPLETED PHASE3
DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection
NCT06203132 RECRUITING PHASE3
Antiretroviral Therapy for Acute HIV Infection
NCT03877536 WITHDRAWN NA
A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
NCT03227861 COMPLETED PHASE3
Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults
NCT00196599 COMPLETED PHASE2
Study to Evaluate the Safety and Effect of HIVconsv Vaccines in Combination With Histone Deacetylase Inhibitor Romidepsin on the Viral Rebound Kinetic After Treatment Interruption in Early Treated HIV-1 Infected Individuals
NCT02616874 COMPLETED PHASE1
Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST
NCT03858478 UNKNOWN PHASE4
Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations
NCT00011089 UNKNOWN NA
Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants
NCT03631732 COMPLETED PHASE3
The Benefits of Immediate Treatment Initiation Without Immunovirological Data Compared to Conventional BIC / FTC / TAF Treatment in Naive Patients With Type 1 HIV (Human Immunodeficiency Virus) Infection
NCT05606055 COMPLETED PHASE4
Early Simplified: A Trial to Compare the Efficacy of Standard of Care Combination Antiretroviral Therapy With a Simplified Dolutegravir Monotherapy in Patients With a Primary HIV-1 Infection
NCT02551523 UNKNOWN PHASE2
Reducing the Residual Reservoir of HIV-1 Infected Cells in Patients Receiving Antiretroviral Therapy
NCT02471430 COMPLETED PHASE1/PHASE2
Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
NCT06513312 ACTIVE_NOT_RECRUITING PHASE2
Mathematical Modeling of the HIV Transmission Risk After Initiation of Antiretroviral Therapy in naïve HIV-infected
NCT03183154 UNKNOWN
Evaluation of the Efficacy and Safety Between Two Antiretroviral Regimens, in HIV-1-infected Treatment-naïve Subjects With Low CD4 Counts
NCT01928407 COMPLETED PHASE4
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
NCT01440569 COMPLETED PHASE3
HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
NCT01384734 COMPLETED PHASE2