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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01489046
Recruitment Status : Terminated
First Posted : December 9, 2011
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: BMS-986001 Drug: Placebo matching with BMS-986001 Drug: Efavirenz Drug: Lamivudine Drug: Tenofovir Phase 2

Detailed Description:
Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators) through Week 48.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine Drug: BMS-986001
Capsules, Oral, 100 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 Name: Sustiva®

Drug: Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Epivir®
Experimental: Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine Drug: BMS-986001
Capsules, Oral, 200 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 Name: Sustiva®

Drug: Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Epivir®
Experimental: Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine 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 Name: Sustiva®

Drug: Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Epivir®
Experimental: Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine Drug: Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Other Name: Sustiva®

Drug: Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Epivir®

Drug: Tenofovir
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Viread®


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses [ Time Frame: Week 24 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses [ Time Frame: Weeks 48 and 96 ]
  2. Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation [ Time Frame: Weeks 48 and 96 ]
  3. Changes from baseline in CD4+ T-cell counts [ Time Frame: Weeks 24, 48, and 96 ]
  4. Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA) [ Time Frame: Weeks 24, 48, and 96 ]
  5. Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ]
  6. Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ]
  7. Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ]
  8. Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ]
  9. 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 ]
  10. Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489046


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01489046    
Other Study ID Numbers: AI467-003
2011-003329-89 ( EudraCT Number )
First Posted: December 9, 2011    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Infection
Tenofovir
Lamivudine
Efavirenz
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers