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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003329-89 | EudraCT Number |
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The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects
Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators) through Week 48.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine | Experimental |
| |
| Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine | Experimental |
| |
| Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine | Experimental |
| |
| Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986001 | Drug | Capsules, Oral, 100 mg, Once daily, At least 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses | 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 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses | Weeks 48 and 96 | |
| Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation | Weeks 48 and 96 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uc Davis Medical Center | Sacramento | California | 95817 | United States | ||
| Orlando Immunology Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26762988 | Derived | Gupta SK, McComsey GA, Lombaard J, Echevarria J, Orrell C, Avihingsanon A, Osiyemi O, Santoscoy M, Ray N, Stock DA, Joshi SR, Hanna GJ, Lataillade M. Efficacy, safety, bone and metabolic effects of HIV nucleoside reverse transcriptase inhibitor BMS-986001 (AI467003): a phase 2b randomised, controlled, partly blinded trial. Lancet HIV. 2016 Jan;3(1):e13-22. doi: 10.1016/S2352-3018(15)00231-3. Epub 2015 Dec 12. |
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| BMS-986001 | Drug | Capsules, Oral, 200 mg, Once daily, At least 48 weeks |
|
| BMS-986001 | Drug | Capsules, Oral, 400 mg, Once daily, At least 48 weeks |
|
| Placebo matching with BMS-986001 | Drug | Capsules, Oral, 0 mg, Once daily, At least 48 weeks |
|
| Efavirenz | Drug | Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase |
|
|
| Lamivudine | Drug | Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase |
|
|
| Tenofovir | Drug | Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase |
|
|
| Changes from baseline in CD4+ T-cell counts | Weeks 24, 48, and 96 |
| Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA) | Weeks 24, 48, and 96 |
| Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC | Week 24 |
| Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC | Week 24 |
| Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC | Week 24 |
| Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC | 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 | Week 24 |
| Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC | Week 24 |
| Orlando |
| Florida |
| 32803 |
| United States |
| Triple O Medical Services, P.A. | West Palm Beach | Florida | 33401 | United States |
| Aids Research Consortium Of Atlanta | Atlanta | Georgia | 30308 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Local Institution | Washingtondc | Maryland | 20009 | United States |
| Clinic 42 And International Travel Clinic | Minneapolis | Minnesota | 55404 | United States |
| University At Buffalo | Buffalo | New York | 14215 | United States |
| Local Institution | New York | New York | 10011 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| Local Institution | Charlotte | North Carolina | 28209 | United States |
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Local Institution | Columbia | South Carolina | 29203 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| St. Hope Foundation | Bellaire | Texas | 77401 | United States |
| North Texas Infectious Disease Consultants | Dallas | Texas | 75246 | United States |
| Tarrant County Infectious Disease Associates | Fort Worth | Texas | 76104 | United States |
| Therapeutic Concepts, P.A. | Houston | Texas | 77004 | United States |
| Local Institution | Ciudad de Buenos Aires | Buenos Aires | C1426EGR | Argentina |
| Local Institution | Darlinghurst | New South Wales | 2010 | Australia |
| Local Institution | Liverpool | New South Wales | 1871 | Australia |
| Local Institution | Melbourne | Victoria | 3004 | Australia |
| Local Institution | Vancouver | British Columbia | V6Z2C7 | Canada |
| Local Institution | Montreal | Quebec | H2L 4P9 | Canada |
| Local Institution | Montreal | Quebec | H2L 5B1 | Canada |
| Local Institution | Santiago | Santiago Metropolitan | 8207257 | Chile |
| Local Institution | Santiago | Santiago Metropolitan | 8330744 | Chile |
| Local Institution | Bogota | Cundinamarca | Colombia |
| Local Institution | Lyon | 69004 | France |
| Local Institution | Budapest | 1097 | Hungary |
| Local Institution | Mexico City | Mexico City | 06470 | Mexico |
| Local Institution | Barranco | Lima region | 4 | Peru |
| Local Institution | San MartÃn de Porres | Lima region | 31 | Peru |
| Local Institution | Cercado | Lima | 1 | Peru |
| Local Institution | Iquitos | Loreto | Peru |
| Local Institution | Bloemfontein | Free State | 9301 | South Africa |
| Local Institution | Johannesburg | Gauteng | 2198 | South Africa |
| Local Institution | Soweto | Gauteng | 2013 | South Africa |
| Local Institution | Dundee | KwaZulu-Natal | 3000 | South Africa |
| Local Institution | Cape Town | Western Cape | 7925 | South Africa |
| Local Institution | Cape Town | 7530 | South Africa |
| Local Institution | Durban | 4001 | South Africa |
| Local Institution | Durban KZN | 4001 | South Africa |
| Local Institution | Badalona | 08916 | Spain |
| Local Institution | Barcelona | 08036 | Spain |
| Local Institution | Madrid | 28040 | Spain |
| Local Institution | Bangkok | 10330 | Thailand |
| Local Institution | Bangkok | 10400 | Thailand |
| Local Institution | Bangkok | 10700 | Thailand |
| Local Institution | Khon Kaen | 40002 | Thailand |
| Local Institution | Nontaburi | 11000 | Thailand |
| ID | Term |
|---|---|
| C583040 | BMS-986001 |
| C098320 | efavirenz |
| D019259 | Lamivudine |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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