HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01384734
First received: June 23, 2011
Last updated: July 2, 2014
Last verified: July 2014

June 23, 2011
July 2, 2014
July 2011
February 2013   (final data collection date for primary outcome measure)
  • Proportion of subjects with plasma HIV-1 ribonucleic acid (RNA) < 50 c/mL [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
  • Frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01384734 on ClinicalTrials.gov Archive Site
  • Changes from monotherapy baseline (Monotherapy Day 1) in log10 HIV ribonucleic acid (RNA) by study day during monotherapy [ Time Frame: Baseline and at Monotherapy Day 7 ] [ Designated as safety issue: No ]
    Monotherapy Substudy
  • Maximum decrease from monotherapy baseline in log10 plasma HIV-1 RNA during monotherapy [ Time Frame: Baseline and at Monotherapy Day 7 ] [ Designated as safety issue: No ]
    Monotherapy Substudy
  • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL at baseline (Combination Therapy Day 1) [ Time Frame: Baseline and at Monotherapy Day 7 ] [ Designated as safety issue: No ]
    Monotherapy Substudy
  • Frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) during monotherapy [ Time Frame: At Monotherapy Day 7 ] [ Designated as safety issue: Yes ]
    Monotherapy Substudy
  • Changes from monotherapy baseline in CD4+ and CD8+ T-cell counts and percents by study day during monotherapy [ Time Frame: Baseline and at Monotherapy Day 7 ] [ Designated as safety issue: No ]
    Monotherapy Substudy
  • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Primary Study
  • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    Primary Study
  • Frequency of SAEs and discontinuations due to AEs [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
    Primary Study
  • Frequency of SAEs and discontinuations due to AEs [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]
    Primary Study
  • Changes from baseline in CD4+ T-cell count [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Primary Study
  • Changes from baseline in CD4+ T-cell count [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    Primary Study
  • Changes from baseline in CD4+ T-cell count [ Time Frame: Baseline and Week 96 ] [ Designated as safety issue: No ]
    Primary Study
  • Frequency of newly-emergent genotypic substitutions among subjects with virologic failure [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Primary Study
  • Frequency of newly-emergent genotypic substitutions among subjects with virologic failure [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Primary Study
  • Frequency of newly-emergent genotypic substitutions among subjects with virologic failure [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    Primary Study
Same as current
Not Provided
Not Provided
 
HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety, Efficacy and Dose-Response of BMS-663068 in Treatment-experienced HIV-1 Subjects, Followed by an Open-Label Period on the Recommended Dose

The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects.

Masking: Double-blind for BMS-6630368 treatment groups until the Week 24 Primary Endpoint analysis, then open label. The reference groups is all open-label.

Arms: 5 (4 BMS-663068 treatment groups and 1 reference group)

Intervention Model: Parallel (with unblinding after the Week 24 primary endpoint analysis)

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
Human Immunodeficiency Virus-1
  • Drug: BMS-663068
    Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
  • Drug: BMS-663068
    Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
  • Drug: BMS-663068
    Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
  • Drug: BMS-663068
    Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
  • Drug: Raltegravir
    Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
    Other Name: Isentress
  • Drug: Raltegravir
    Tablets, Oral, 400 mg, twice daily (BID), 96 weeks
    Other Name: Isentress
  • Drug: Tenofovir
    Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
    Other Name: Viread
  • Drug: Tenofovir
    Tablets, Oral, 300 mg, Once daily (QD), 96 weeks
    Other Name: Viread
  • Drug: Ritonavir
    Tablets, Oral, 100 mg, Once daily, 96 weeks
    Other Name: Norvir
  • Drug: Atazanavir
    Capsules, Oral, 300 mg, Once daily, 96 weeks
    Other Name: Reyataz
  • Experimental: Arm A: BMS-663068 + Raltegravir + Tenofovir
    Treatment Group 1
    Interventions:
    • Drug: BMS-663068
    • Drug: Raltegravir
    • Drug: Tenofovir
  • Experimental: Arm B: BMS-663068 + Raltegravir + Tenofovir
    Treatment Group 2
    Interventions:
    • Drug: BMS-663068
    • Drug: Raltegravir
    • Drug: Tenofovir
  • Experimental: Arm C: BMS-663068 + Raltegravir + Tenofovir
    Treatment Group 3
    Interventions:
    • Drug: BMS-663068
    • Drug: Raltegravir
    • Drug: Tenofovir
  • Experimental: Arm D: BMS-663068 + Raltegravir + Tenofovir
    Treatment Group 4
    Interventions:
    • Drug: BMS-663068
    • Drug: Raltegravir
    • Drug: Tenofovir
  • Active Comparator: Arm E: Atazanavir + Ritonavir + Raltegravir + Tenofovir
    Treatment Group 1 (reference arm)
    Interventions:
    • Drug: Raltegravir
    • Drug: Tenofovir
    • Drug: Ritonavir
    • Drug: Atazanavir
Zhou N, Nowicka-Sans B, McAuliffe B, Ray N, Eggers B, Fang H, Fan L, Healy M, Langley DR, Hwang C, Lataillade M, Hanna GJ, Krystal M. Genotypic correlates of susceptibility to HIV-1 attachment inhibitor BMS-626529, the active agent of the prodrug BMS-663068. J Antimicrob Chemother. 2014 Mar;69(3):573-81. doi: 10.1093/jac/dkt412. Epub 2013 Oct 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
July 2018
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Plasma HIV-1 RNA ≥ 1000 copies/ml at Screening
  • Treatment experience with antiretroviral therapies (excluding integrase inhibitors)
  • Screening PhenoSense® Entry indicating BMS-626529 inhibitory concentration (IC)50 < 0.1 μM
  • Cluster of differentiation (CD)4+ T-cell count > 50 cells/mm3

Exclusion Criteria:

  • History (or evidence at Screening) of genotypic resistance to any component of the study regimen [ Tenofovir Disoproxil Fumarate (TDF), Atazanavir (ATV), Raltegravir (RAL)]
  • Certain laboratory and electrocardiogram (ECG) values
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Colombia,   Germany,   Mexico,   Peru,   Romania,   Russian Federation,   South Africa,   Spain
 
NCT01384734
AI438-011, 2011-000437-36
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