Clinical trial NCT01489046: Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV-1 Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-12-09
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses
timeFrame: Week 24
measure: Safety as measured by numbers of subjects with Serious Adverse Events (SAEs) and numbers of subjects with Adverse Events (AEs) leading to discontinuations
timeFrame: Week 24
Secondary outcomes:
measure: Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses
timeFrame: Weeks 48 and 96
measure: Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation
timeFrame: Weeks 48 and 96
measure: Changes from baseline in CD4+ T-cell counts
timeFrame: Weeks 24, 48, and 96
measure: Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA)
timeFrame: Weeks 24, 48, and 96
measure: Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC
timeFrame: Week 24
measure: Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC
timeFrame: Week 24
measure: Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC
timeFrame: Week 24
measure: Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC
timeFrame: Week 24
measure: Area under the concentration-time curve in one dosing interval [AUC(0-24)] of BMS-986001 when co-administered with EFV and 3TC
timeFrame: Week 24
measure: Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC
timeFrame: Week 24
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Uc Davis Medical Center
state: California
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Medical Services, P.A.
state: Florida
city: Atlanta
country: United States
facility: Aids Research Consortium Of Atlanta
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Washingtondc
country: United States
facility: Local Institution
state: Maryland
city: Minneapolis
country: United States
facility: Clinic 42 And International Travel Clinic
state: Minnesota
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Buffalo
country: United States
facility: University At Buffalo
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Charlotte
country: United States
facility: Local Institution
state: North Carolina
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Columbia
country: United States
facility: Local Institution
state: South Carolina
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Bellaire
country: United States
facility: St. Hope Foundation
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Disease Consultants
state: Texas
city: Fort Worth
country: United States
facility: Tarrant County Infectious Disease Associates
state: Texas
city: Houston
country: United States
facility: Therapeutic Concepts, P.A.
state: Texas
city: Ciudad De Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Darlinghurst
country: Australia
facility: Local Institution
state: New South Wales
city: Liverpool
country: Australia
facility: Local Institution
state: New South Wales
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Santiago
country: Chile
facility: Local Institution
city: Santiago
country: Chile
facility: Local Institution
city: Bogota
country: Colombia
facility: Local Institution
state: Cundinamarca
city: Lyon
country: France
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Mexico Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Barranco
country: Peru
facility: Local Institution
state: Lima
city: Cercado
country: Peru
facility: Local Institution
state: Lima
city: San Martin De Porres
country: Peru
facility: Local Institution
state: Lima
city: Iquitos
country: Peru
facility: Local Institution
state: Loreto
city: Bloemfontein
country: South Africa
facility: Local Institution
state: Free State
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Soweto
country: South Africa
facility: Local Institution
state: Gauteng
city: Dundee
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Cape Town
country: South Africa
facility: Local Institution
city: Durban KZN
country: South Africa
facility: Local Institution
city: Durban
country: South Africa
facility: Local Institution
city: Badalona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Bangkok
country: Thailand
facility: Local Institution
city: Khon Kaen
country: Thailand
facility: Local Institution
city: Nontaburi
country: Thailand
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.