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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: November 20, 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
  Purpose
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.

Condition Intervention Phase
Infection, Human Immunodeficiency Virus Drug: BMS-663068 400 mg Drug: BMS-663068 800 mg Drug: BMS-663068 600 mg Drug: BMS-663068 1200 mg Drug: Raltegravir 400 mg Drug: Tenofovir 300 mg Drug: Ritonavir 100 mg Drug: Atazanavir 300 mg Phase 2

Study Type: Interventional
Study Design: 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 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

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 254
Actual Study Start Date: July 26, 2011
Study Completion Date: May 12, 2017
Primary Completion Date: February 18, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: BMS-663068 (400mg) + Raltegravir + Tenofovir
Treatment Group 1
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: 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
Experimental: Arm B: BMS-663068 (800 mg) + Raltegravir + Tenofovir
Treatment Group 2
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: 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
Experimental: Arm C: BMS-663068 (600 mg) + Raltegravir + Tenofovir
Treatment Group 3
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: 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
Experimental: Arm D: BMS-663068 (1200 mg) + Raltegravir + Tenofovir
Treatment Group 4
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
Active Comparator: Arm E: Atazanavir + Ritonavir + Raltegravir + Tenofovir
Treatment Group 1 (reference arm)
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

Detailed Description:

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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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): NCT01384734


  Show 56 Study Locations
Sponsors and Collaborators
ViiV Healthcare
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01384734     History of Changes
Other Study ID Numbers: 205889
AI438-011 ( Other Identifier: Bristol-Myers Squibb )
First Submitted: June 23, 2011
First Posted: June 29, 2011
Last Update Posted: November 20, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Infection
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Ritonavir
Atazanavir Sulfate
Tenofovir
Raltegravir Potassium
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors