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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01489046
First received: December 7, 2011
Last updated: July 14, 2014
Last verified: July 2014

December 7, 2011
July 14, 2014
February 2011
March 2013   (final data collection date for primary outcome measure)
  • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01489046 on ClinicalTrials.gov Archive Site
  • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
  • Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: Yes ]
  • Changes from baseline in CD4+ T-cell counts [ Time Frame: Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
  • Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA) [ Time Frame: Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
  • Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive
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

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV-1 Infection
  • 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®
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
301
July 2014
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Thailand,   South Africa,   Spain,   Argentina,   Australia,   Canada,   Chile,   Colombia,   France,   Hungary,   Mexico,   Peru
 
NCT01489046
AI467-003, 2011-003329-89
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2014

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