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

Primary Purpose

HIV-1 Infection

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986001
BMS-986001
BMS-986001
Placebo matching with BMS-986001
Efavirenz
Lamivudine
Tenofovir
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uc Davis Medical Center
  • Orlando Immunology Center
  • Triple O Medical Services, P.A.
  • Aids Research Consortium Of Atlanta
  • Indiana University
  • Local Institution
  • Clinic 42 And International Travel Clinic
  • Jacobi Medical Center
  • University At Buffalo
  • Local Institution
  • Local Institution
  • University Of Pennsylvania
  • Local Institution
  • Central Texas Clinical Research
  • St. Hope Foundation
  • North Texas Infectious Disease Consultants
  • Tarrant County Infectious Disease Associates
  • Therapeutic Concepts, P.A.
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine

Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine

Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine

Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses
Safety as measured by numbers of subjects with Serious Adverse Events (SAEs) and numbers of subjects with Adverse Events (AEs) leading to discontinuations

Secondary Outcome Measures

Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses
Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation
Changes from baseline in CD4+ T-cell counts
Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA)
Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC
Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC
Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC
Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC
Area under the concentration-time curve in one dosing interval [AUC(0-24)] of BMS-986001 when co-administered with EFV and 3TC
Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC

Full Information

First Posted
December 7, 2011
Last Updated
March 17, 2016
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01489046
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: BMS-986001 (100 mg) + Placebo + Efavirenz + Lamivudine
Arm Type
Experimental
Arm Title
Arm 2: BMS-986001 (200 mg) + Placebo + Efavirenz + Lamivudine
Arm Type
Experimental
Arm Title
Arm 3: BMS-986001 (400 mg) + Efavirenz + Lamivudine
Arm Type
Experimental
Arm Title
Arm 4: Tenofovir (300 mg) + Efavirenz + Lamivudine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986001
Intervention Description
Capsules, Oral, 100 mg, Once daily, At least 48 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-986001
Intervention Description
Capsules, Oral, 200 mg, Once daily, At least 48 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-986001
Intervention Description
Capsules, Oral, 400 mg, Once daily, At least 48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo matching with BMS-986001
Intervention Description
Capsules, Oral, 0 mg, Once daily, At least 48 weeks
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Other Intervention Name(s)
Sustiva®
Intervention Description
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Other Intervention Name(s)
Epivir®
Intervention Description
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Intervention Type
Drug
Intervention Name(s)
Tenofovir
Other Intervention Name(s)
Viread®
Intervention Description
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Primary Outcome Measure Information:
Title
Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses
Time Frame
Week 24
Title
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
Secondary Outcome Measure Information:
Title
Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses
Time Frame
Weeks 48 and 96
Title
Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation
Time Frame
Weeks 48 and 96
Title
Changes from baseline in CD4+ T-cell counts
Time Frame
Weeks 24, 48, and 96
Title
Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA)
Time Frame
Weeks 24, 48, and 96
Title
Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC
Time Frame
Week 24
Title
Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC
Time Frame
Week 24
Title
Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC
Time Frame
Week 24
Title
Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC
Time Frame
Week 24
Title
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
Title
Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Uc Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Triple O Medical Services, P.A.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Aids Research Consortium Of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Local Institution
City
Washingtondc
State/Province
Maryland
ZIP/Postal Code
20009
Country
United States
Facility Name
Clinic 42 And International Travel Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
University At Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Local Institution
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Institution
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
St. Hope Foundation
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
North Texas Infectious Disease Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Tarrant County Infectious Disease Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Therapeutic Concepts, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Local Institution
City
Ciudad De Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1426EGR
Country
Argentina
Facility Name
Local Institution
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Local Institution
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
1871
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z2C7
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
Local Institution
City
Santiago
ZIP/Postal Code
8207257
Country
Chile
Facility Name
Local Institution
City
Santiago
ZIP/Postal Code
8330744
Country
Chile
Facility Name
Local Institution
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Local Institution
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Local Institution
City
Mexico Df
State/Province
Distrito Federal
ZIP/Postal Code
06470
Country
Mexico
Facility Name
Local Institution
City
Barranco
State/Province
Lima
ZIP/Postal Code
4
Country
Peru
Facility Name
Local Institution
City
Cercado
State/Province
Lima
ZIP/Postal Code
1
Country
Peru
Facility Name
Local Institution
City
San Martin De Porres
State/Province
Lima
ZIP/Postal Code
31
Country
Peru
Facility Name
Local Institution
City
Iquitos
State/Province
Loreto
Country
Peru
Facility Name
Local Institution
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Local Institution
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2198
Country
South Africa
Facility Name
Local Institution
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Local Institution
City
Dundee
State/Province
Kwa Zulu Natal
ZIP/Postal Code
3000
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Local Institution
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Local Institution
City
Durban KZN
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Local Institution
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Local Institution
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Local Institution
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Local Institution
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Local Institution
City
Nontaburi
ZIP/Postal Code
11000
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
26762988
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.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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

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