Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive
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ClinicalTrials.gov Identifier: NCT01489046 |
Recruitment Status :
Terminated
First Posted : December 9, 2011
Last Update Posted : April 15, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV-1 Infection | Drug: BMS-986001 Drug: Placebo matching with BMS-986001 Drug: Efavirenz Drug: Lamivudine Drug: Tenofovir | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 297 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 Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | July 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine |
Drug: BMS-986001
Capsules, Oral, 100 mg, Once daily, At least 48 weeks Drug: Placebo matching with BMS-986001 Capsules, Oral, 0 mg, Once daily, At least 48 weeks Drug: Efavirenz Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Other Name: Sustiva® Drug: Lamivudine Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Epivir® |
Experimental: Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine |
Drug: BMS-986001
Capsules, Oral, 200 mg, Once daily, At least 48 weeks Drug: Placebo matching with BMS-986001 Capsules, Oral, 0 mg, Once daily, At least 48 weeks Drug: Efavirenz Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Other Name: Sustiva® Drug: Lamivudine Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Epivir® |
Experimental: Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine |
Drug: BMS-986001
Capsules, Oral, 400 mg, Once daily, At least 48 weeks Drug: Efavirenz Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Other Name: Sustiva® Drug: Lamivudine Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Epivir® |
Experimental: Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine |
Drug: Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Other Name: Sustiva® Drug: Lamivudine Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Epivir® Drug: Tenofovir Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Other Name: Viread® |
- Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses [ Time Frame: Week 24 ]
- Safety as measured by numbers of subjects with Serious Adverse Events (SAEs) and numbers of subjects with Adverse Events (AEs) leading to discontinuations [ Time Frame: Week 24 ]
- Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses [ Time Frame: Weeks 48 and 96 ]
- Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation [ Time Frame: Weeks 48 and 96 ]
- Changes from baseline in CD4+ T-cell counts [ Time Frame: Weeks 24, 48, and 96 ]
- Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA) [ Time Frame: Weeks 24, 48, and 96 ]
- Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ]
- Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ]
- Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ]
- Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ]
- Area under the concentration-time curve in one dosing interval [AUC(0-24)] of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ]
- Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC [ Time Frame: Week 24 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher)
- Plasma HIV-1 RNA > 5000 copies/mL
- Antiretroviral treatment-naive; defined as no current or previous exposure to > 1 week of an antiretroviral drug
- CD4+ T-cell count > 200 cells/mm3
Exclusion Criteria:
- Resistance to any of the study medications [Tenofovir Disoproxil Fumarate(TDF), Efavirenz (EFV), Lamivudine (3TC)] or to HIV Protease Inhibitors (PIs)
- Contraindications to any of the study drugs

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): NCT01489046

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT01489046 |
Other Study ID Numbers: |
AI467-003 2011-003329-89 ( EudraCT Number ) |
First Posted: | December 9, 2011 Key Record Dates |
Last Update Posted: | April 15, 2016 |
Last Verified: | March 2016 |
Infection Tenofovir Lamivudine Efavirenz Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |