HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
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ClinicalTrials.gov Identifier: NCT01384734 |
Recruitment Status
:
Completed
First Posted
: June 29, 2011
Last Update Posted
: April 6, 2018
|
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Condition or disease | Intervention/treatment | 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 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 254 participants |
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 |
Actual Study Start Date : | July 26, 2011 |
Actual Primary Completion Date : | February 18, 2013 |
Actual Study Completion Date : | May 12, 2017 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 ]
- 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

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

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

Study Director: | GSK Clinical Trials | ViiV Healthcare |
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 Posted: | June 29, 2011 Key Record Dates |
Last Update Posted: | April 6, 2018 |
Last Verified: | April 2018 |
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 |