We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01384734
First Posted: June 29, 2011
Last Update Posted: September 7, 2017
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.
Information provided by (Responsible Party):
ViiV Healthcare
June 23, 2011
June 29, 2011
September 7, 2017
July 26, 2011
May 12, 2017   (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 ]
  • Frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) [ Time Frame: Up to Week 24 ]
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 ]
    Monotherapy Substudy
  • Maximum decrease from monotherapy baseline in log10 plasma HIV-1 RNA during monotherapy [ Time Frame: Baseline and at Monotherapy Day 7 ]
    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 ]
    Monotherapy Substudy
  • Frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) during monotherapy [ Time Frame: At Monotherapy Day 7 ]
    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 ]
    Monotherapy Substudy
  • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL [ Time Frame: Week 48 ]
    Primary Study
  • Frequency of SAEs and discontinuations due to AEs [ Time Frame: Week 48 ]
    Primary Study
  • Frequency of SAEs and discontinuations due to AE [ Time Frame: Week 96 ]
    Primary Study
  • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL. [ Time Frame: Week 96 ]
    Primary Study
  • Changes from baseline in CD4+ T-cell count [ Time Frame: Baseline and Week 24 ]
    Primary Study
  • Changes from baseline in CD4+ T-cell count. [ Time Frame: Baseline and Week 48 ]
    Primary Study
  • Changes from baseline in CD4+ T-cell count, [ Time Frame: Baseline and Week 96 ]
    Primary Study
  • Frequency of newly-emergent genotypic substitutions among subjects with virologic failure [ Time Frame: Week 24 ]
    Primary Study
  • Frequency of newly-emergent genotypic substitutions among subjects with virologic failure. [ Time Frame: Week 48 ]
    Primary Study
  • Frequency of newly-emergent genotypic substitutions among subjects with virologic failure, [ Time Frame: Week 96 ]
    Primary Study
  • 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 ]
    Monotherapy Substudy
  • Maximum decrease from monotherapy baseline in log10 plasma HIV-1 RNA during monotherapy [ Time Frame: Baseline and at Monotherapy Day 7 ]
    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 ]
    Monotherapy Substudy
  • Frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) during monotherapy [ Time Frame: At Monotherapy Day 7 ]
    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 ]
    Monotherapy Substudy
  • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL [ Time Frame: Week 48 ]
    Primary Study
  • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL [ Time Frame: Week 96 ]
    Primary Study
  • Frequency of SAEs and discontinuations due to AEs [ Time Frame: Week 48 ]
    Primary Study
  • Frequency of SAEs and discontinuations due to AEs [ Time Frame: Week 96 ]
    Primary Study
  • Changes from baseline in CD4+ T-cell count [ Time Frame: Baseline and Week 24 ]
    Primary Study
  • Changes from baseline in CD4+ T-cell count [ Time Frame: Baseline and Week 48 ]
    Primary Study
  • Changes from baseline in CD4+ T-cell count [ Time Frame: Baseline and Week 96 ]
    Primary Study
  • Frequency of newly-emergent genotypic substitutions among subjects with virologic failure [ Time Frame: Week 24 ]
    Primary Study
  • Frequency of newly-emergent genotypic substitutions among subjects with virologic failure [ Time Frame: Week 48 ]
    Primary Study
  • Frequency of newly-emergent genotypic substitutions among subjects with virologic failure [ Time Frame: Week 96 ]
    Primary Study
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. PHENOSENSE® is a registered trademark of Monogram Biosciences.

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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Infection, Human Immunodeficiency Virus
  • Drug: BMS-663068 400 mg
    Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
  • Drug: BMS-663068 800 mg
    Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
  • Drug: BMS-663068 600 mg
    Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
  • Drug: BMS-663068 1200 mg
    Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
  • Drug: Raltegravir 400 mg
    Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
  • Drug: Tenofovir 300 mg
    Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
  • Drug: Ritonavir 100 mg
    Tablets, Oral, 100 mg, Once daily, 96 weeks
  • Drug: Atazanavir 300 mg
    Capsules, Oral, 300 mg, Once daily, 96 weeks
  • Experimental: Arm A: BMS-663068 (400mg) + Raltegravir + Tenofovir
    Treatment Group 1
    Interventions:
    • Drug: BMS-663068 400 mg
    • Drug: Raltegravir 400 mg
    • Drug: Tenofovir 300 mg
  • Experimental: Arm B: BMS-663068 (800 mg) + Raltegravir + Tenofovir
    Treatment Group 2
    Interventions:
    • Drug: BMS-663068 800 mg
    • Drug: Raltegravir 400 mg
    • Drug: Tenofovir 300 mg
  • Experimental: Arm C: BMS-663068 (600 mg) + Raltegravir + Tenofovir
    Treatment Group 3
    Interventions:
    • Drug: BMS-663068 600 mg
    • Drug: Raltegravir 400 mg
    • Drug: Tenofovir 300 mg
  • Experimental: Arm D: BMS-663068 (1200 mg) + Raltegravir + Tenofovir
    Treatment Group 4
    Interventions:
    • Drug: BMS-663068 1200 mg
    • Drug: Raltegravir 400 mg
    • Drug: Tenofovir 300 mg
  • Active Comparator: Arm E: Atazanavir + Ritonavir + Raltegravir + Tenofovir
    Treatment Group 1 (reference arm)
    Interventions:
    • Drug: Raltegravir 400 mg
    • Drug: Tenofovir 300 mg
    • Drug: Ritonavir 100 mg
    • Drug: Atazanavir 300 mg

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
May 12, 2017
May 12, 2017   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Colombia,   Germany,   Mexico,   Peru,   Romania,   Russian Federation,   South Africa,   Spain,   United States
 
 
NCT01384734
205889
AI438-011 ( Other Identifier: Bristol-Myers Squibb )
Yes
Not Provided
Not Provided
ViiV Healthcare
ViiV Healthcare
Not Provided
Study Director: GSK Clinical Trials ViiV Healthcare
ViiV Healthcare
September 2017

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