Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive

HIV-1 Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01489046
• Other study ID #: AI467-003
• Secondary ID: 2011-003329-89
• Status: Terminated
• Phase: Phase 2
• First received: December 7, 2011
• Last updated: July 14, 2014
• Start date: February 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control CouncilAustralia: Department of Health and Ageing Therapeutic Goods AdministrationThailand: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Pharmacy and Medicines InstituteSpain: Agencia Española de Medicamentos y Productos SanitariosArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: National Health Surveillance AgencyChile: Instituto de Salud Pública de ChileColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosMexico: Federal Commission for Sanitary Risks ProtectionPeru: General Directorate of Pharmaceuticals, Devices, and DrugsCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Description:

Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators) through Week 48.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 301
• Est. completion date: July 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV Infections
• HIV-1 Infection

Intervention

Drug:
• BMS-986001
Capsules, Oral, 100 mg, Once daily, At least 48 weeks
• BMS-986001
Capsules, Oral, 200 mg, Once daily, At least 48 weeks
• BMS-986001
Capsules, Oral, 400 mg, Once daily, At least 48 weeks
• Placebo matching with BMS-986001
Capsules, Oral, 0 mg, Once daily, At least 48 weeks
• Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
• Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
• Tenofovir
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase

Locations

Country	Name	City	State
Argentina	Local Institution	Ciudad De Buenos Aires	Buenos Aires
Australia	Local Institution	Darlinghurst	New South Wales
Australia	Local Institution	Liverpool	New South Wales
Australia	Local Institution	Melbourne	Victoria
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Vancouver	British Columbia
Chile	Local Institution	Santiago
Chile	Local Institution	Santiago
Colombia	Local Institution	Bogota	Cundinamarca
France	Local Institution	Lyon
Hungary	Local Institution	Budapest
Mexico	Local Institution	Mexico Df	Distrito Federal
Peru	Local Institution	Barranco	Lima
Peru	Local Institution	Cercado	Lima
Peru	Local Institution	Iquitos	Loreto
Peru	Local Institution	San Martin De Porres	Lima
South Africa	Local Institution	Bloemfontein	Free State
South Africa	Local Institution	Cape Town	Western Cape
South Africa	Local Institution	Cape Town
South Africa	Local Institution	Dundee	Kwa Zulu Natal
South Africa	Local Institution	Durban
South Africa	Local Institution	Durban KZN
South Africa	Local Institution	Johannesburg	Gauteng
South Africa	Local Institution	Soweto	Gauteng
Spain	Local Institution	Badalona
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Thailand	Local Institution	Bangkok
Thailand	Local Institution	Bangkok
Thailand	Local Institution	Bangkok
Thailand	Local Institution	Khon Kaen
Thailand	Local Institution	Nontaburi
United States	Aids Research Consortium Of Atlanta	Atlanta	Georgia
United States	Central Texas Clinical Research	Austin	Texas
United States	St. Hope Foundation	Bellaire	Texas
United States	Jacobi Medical Center	Bronx	New York
United States	University At Buffalo	Buffalo	New York
United States	Local Institution	Charlotte	North Carolina
United States	Local Institution	Columbia	South Carolina
United States	North Texas Infectious Disease Consultants	Dallas	Texas
United States	Tarrant County Infectious Disease Associates	Fort Worth	Texas
United States	Therapeutic Concepts, P.A.	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Clinic 42 And International Travel Clinic	Minneapolis	Minnesota
United States	Local Institution	New York	New York
United States	Orlando Immunology Center	Orlando	Florida
United States	University Of Pennsylvania	Philadelphia	Pennsylvania
United States	Uc Davis Medical Center	Sacramento	California
United States	Local Institution	Washingtondc	Maryland
United States	Triple O Medical Services, P.A.	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Chile,  Colombia,  France,  Hungary,  Mexico,  Peru,  South Africa,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses		Week 24	No
Primary	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	Yes
Secondary	Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses		Weeks 48 and 96	No
Secondary	Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation		Weeks 48 and 96	Yes
Secondary	Changes from baseline in CD4+ T-cell counts		Weeks 24, 48, and 96	No
Secondary	Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA)		Weeks 24, 48, and 96	No
Secondary	Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC		Week 24	No
Secondary	Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC		Week 24	No
Secondary	Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC		Week 24	No
Secondary	Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC		Week 24	No
Secondary	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	No
Secondary	Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC		Week 24	No

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