Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive

March 17, 2016 updated by: Bristol-Myers Squibb

A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose

The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators) through Week 48.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
297

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1426EGR
        • Local Institution
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Local Institution
      • Liverpool, New South Wales, Australia, 1871
        • Local Institution
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Local Institution
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z2C7
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H2L 4P9
        • Local Institution
      • Montreal, Quebec, Canada, H2L 5B1
        • Local Institution
  • Chile
      • Santiago, Chile, 8207257
        • Local Institution
      • Santiago, Chile, 8330744
        • Local Institution
  • Colombia
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Local Institution
  • France
      • Lyon, France, 69004
        • Local Institution
  • Hungary
      • Budapest, Hungary, 1097
        • Local Institution
  • Mexico
    • Distrito Federal
      • Mexico Df, Distrito Federal, Mexico, 06470
        • Local Institution
  • Peru
    • Lima
      • Barranco, Lima, Peru, 4
        • Local Institution
      • Cercado, Lima, Peru, 1
        • Local Institution
      • San Martin De Porres, Lima, Peru, 31
        • Local Institution
    • Loreto
      • Iquitos, Loreto, Peru
        • Local Institution
  • South Africa
      • Cape Town, South Africa, 7530
        • Local Institution
      • Durban, South Africa, 4001
        • Local Institution
      • Durban KZN, South Africa, 4001
        • Local Institution
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Local Institution
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2198
        • Local Institution
      • Soweto, Gauteng, South Africa, 2013
        • Local Institution
    • Kwa Zulu Natal
      • Dundee, Kwa Zulu Natal, South Africa, 3000
        • Local Institution
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Local Institution
  • Spain
      • Badalona, Spain, 08916
        • Local Institution
      • Barcelona, Spain, 08036
        • Local Institution
      • Madrid, Spain, 28040
        • Local Institution
  • Thailand
      • Bangkok, Thailand, 10400
        • Local Institution
      • Bangkok, Thailand, 10700
        • Local Institution
      • Bangkok, Thailand, 10330
        • Local Institution
      • Khon Kaen, Thailand, 40002
        • Local Institution
      • Nontaburi, Thailand, 11000
        • Local Institution
  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center
    • Florida
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
      • West Palm Beach, Florida, United States, 33401
        • Triple O Medical Services, P.A.
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Maryland
      • Washingtondc, Maryland, United States, 20009
        • Local Institution
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Clinic 42 And International Travel Clinic
    • New York
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center
      • Buffalo, New York, United States, 14215
        • University at Buffalo
      • New York, New York, United States, 10011
        • Local Institution
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Local Institution
    • Texas
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • Bellaire, Texas, United States, 77401
        • St. Hope Foundation
      • Dallas, Texas, United States, 75246
        • North Texas Infectious Disease Consultants
      • Fort Worth, Texas, United States, 76104
        • Tarrant County Infectious Disease Associates
      • Houston, Texas, United States, 77004
        • Therapeutic Concepts, P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher)
  • Plasma HIV-1 RNA > 5000 copies/mL
  • Antiretroviral treatment-naive; defined as no current or previous exposure to > 1 week of an antiretroviral drug
  • CD4+ T-cell count > 200 cells/mm3

Exclusion Criteria:

  • Resistance to any of the study medications [Tenofovir Disoproxil Fumarate(TDF), Efavirenz (EFV), Lamivudine (3TC)] or to HIV Protease Inhibitors (PIs)
  • Contraindications to any of the study drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine
Drug: BMS-986001
Capsules, Oral, 100 mg, Once daily, At least 48 weeks
Drug: BMS-986001
Capsules, Oral, 200 mg, Once daily, At least 48 weeks
Drug: BMS-986001
Capsules, Oral, 400 mg, Once daily, At least 48 weeks
Drug: Placebo matching with BMS-986001
Capsules, Oral, 0 mg, Once daily, At least 48 weeks
Drug: Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Other Names:
  • Sustiva®
Drug: Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Names:
  • Epivir®
Experimental: Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine
Drug: BMS-986001
Capsules, Oral, 100 mg, Once daily, At least 48 weeks
Drug: BMS-986001
Capsules, Oral, 200 mg, Once daily, At least 48 weeks
Drug: BMS-986001
Capsules, Oral, 400 mg, Once daily, At least 48 weeks
Drug: Placebo matching with BMS-986001
Capsules, Oral, 0 mg, Once daily, At least 48 weeks
Drug: Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Other Names:
  • Sustiva®
Drug: Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Names:
  • Epivir®
Experimental: Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine
Drug: BMS-986001
Capsules, Oral, 100 mg, Once daily, At least 48 weeks
Drug: BMS-986001
Capsules, Oral, 200 mg, Once daily, At least 48 weeks
Drug: BMS-986001
Capsules, Oral, 400 mg, Once daily, At least 48 weeks
Drug: Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Other Names:
  • Sustiva®
Drug: Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Names:
  • Epivir®
Experimental: Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine
Drug: Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Other Names:
  • Sustiva®
Drug: Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Names:
  • Epivir®
Drug: Tenofovir
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Names:
  • Viread®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses
Time Frame: Week 24
Week 24
Safety as measured by numbers of subjects with Serious Adverse Events (SAEs) and numbers of subjects with Adverse Events (AEs) leading to discontinuations
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses
Time Frame: Weeks 48 and 96
Weeks 48 and 96
Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation
Time Frame: Weeks 48 and 96
Weeks 48 and 96
Changes from baseline in CD4+ T-cell counts
Time Frame: Weeks 24, 48, and 96
Weeks 24, 48, and 96
Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA)
Time Frame: Weeks 24, 48, and 96
Weeks 24, 48, and 96
Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC
Time Frame: Week 24
Week 24
Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC
Time Frame: Week 24
Week 24
Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC
Time Frame: Week 24
Week 24
Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC
Time Frame: Week 24
Week 24
Area under the concentration-time curve in one dosing interval [AUC(0-24)] of BMS-986001 when co-administered with EFV and 3TC
Time Frame: Week 24
Week 24
Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AI467-003
  • 2011-003329-89 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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