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

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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

Tracking Information
First Submitted Date  ICMJE December 7, 2011
First Posted Date  ICMJE December 9, 2011
Last Update Posted Date April 15, 2016
Study Start Date  ICMJE February 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2011)
  • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2011)
  • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses [ Time Frame: 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 ]
  • Changes from baseline in CD4+ T-cell counts [ Time Frame: 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 ]
  • Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ]
  • Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: 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 ]
  • Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: 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 ]
  • Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive
Official Title  ICMJE 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
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
Detailed Description Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators) through Week 48.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection
Intervention  ICMJE
  • 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 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®
Study Arms  ICMJE
  • Experimental: Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine
    Interventions:
    • Drug: BMS-986001
    • Drug: Placebo matching with BMS-986001
    • Drug: Efavirenz
    • Drug: Lamivudine
  • Experimental: Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine
    Interventions:
    • Drug: BMS-986001
    • Drug: Placebo matching with BMS-986001
    • Drug: Efavirenz
    • Drug: Lamivudine
  • Experimental: Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine
    Interventions:
    • Drug: BMS-986001
    • Drug: Efavirenz
    • Drug: Lamivudine
  • Experimental: Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine
    Interventions:
    • Drug: Efavirenz
    • Drug: Lamivudine
    • Drug: Tenofovir
Publications * Gupta SK, McComsey GA, Lombaard J, Echevarría J, Orrell C, Avihingsanon A, Osiyemi O, Santoscoy M, Ray N, Stock DA, Joshi SR, Hanna GJ, Lataillade M. Efficacy, safety, bone and metabolic effects of HIV nucleoside reverse transcriptase inhibitor BMS-986001 (AI467003): a phase 2b randomised, controlled, partly blinded trial. Lancet HIV. 2016 Jan;3(1):e13-22. doi: 10.1016/S2352-3018(15)00231-3. Epub 2015 Dec 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 17, 2016)
297
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2011)
400
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   Chile,   Colombia,   France,   Hungary,   Mexico,   Peru,   South Africa,   Spain,   Thailand,   United States
Removed Location Countries Brazil,   Germany,   Poland,   Portugal
 
Administrative Information
NCT Number  ICMJE NCT01489046
Other Study ID Numbers  ICMJE AI467-003
2011-003329-89 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP