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: August 23, 2016

Last verified: June 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

June 23, 2011

Last Updated Date

August 23, 2016

Start Date ^ICMJE

July 2011

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01384734 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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)

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Human Immunodeficiency Virus-1

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* 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

Active, not recruiting

Estimated Enrollment ^ICMJE

250

Estimated Completion Date

September 2016

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States, Argentina, Colombia, Germany, Mexico, Peru, Romania, Russian Federation, South Africa, Spain

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01384734

Other Study ID Numbers ^ICMJE

AI438-011, 2011-000437-36

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

June 2016

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

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