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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01489046




Registration number
NCT01489046
Ethics application status
Date submitted
7/12/2011
Date registered
9/12/2011
Date last updated
15/04/2016

Titles & IDs
Public title
Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive
Scientific 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
Secondary ID [1] 0 0
2011-003329-89
Secondary ID [2] 0 0
AI467-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986001
Treatment: Drugs - BMS-986001
Treatment: Drugs - BMS-986001
Treatment: Drugs - Placebo matching with BMS-986001
Treatment: Drugs - Efavirenz
Treatment: Drugs - Lamivudine
Treatment: Drugs - Tenofovir

Experimental: 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 -


Treatment: Drugs: BMS-986001
Capsules, Oral, 100 mg, Once daily, At least 48 weeks

Treatment: Drugs: BMS-986001
Capsules, Oral, 200 mg, Once daily, At least 48 weeks

Treatment: Drugs: BMS-986001
Capsules, Oral, 400 mg, Once daily, At least 48 weeks

Treatment: Drugs: Placebo matching with BMS-986001
Capsules, Oral, 0 mg, Once daily, At least 48 weeks

Treatment: Drugs: Efavirenz
Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase

Treatment: Drugs: Lamivudine
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase

Treatment: Drugs: Tenofovir
Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Safety as measured by numbers of subjects with Serious Adverse Events (SAEs) and numbers of subjects with Adverse Events (AEs) leading to discontinuations
Timepoint [2] 0 0
Week 24
Secondary outcome [1] 0 0
Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses
Timepoint [1] 0 0
Weeks 48 and 96
Secondary outcome [2] 0 0
Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuation
Timepoint [2] 0 0
Weeks 48 and 96
Secondary outcome [3] 0 0
Changes from baseline in CD4+ T-cell counts
Timepoint [3] 0 0
Weeks 24, 48, and 96
Secondary outcome [4] 0 0
Numbers of subjects with virologic failure who exhibit genotypic substitutions in viral Ribonucleic acid (RNA)
Timepoint [4] 0 0
Weeks 24, 48, and 96
Secondary outcome [5] 0 0
Maximum observed concentration (Cmax) of BMS-986001 when co-administered with EFV and 3TC
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Time of maximum observed concentration (Tmax) of BMS-986001 when co-administered with EFV and 3TC
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Trough plasma concentration at 24 h post observed dose (Cmin) of BMS-986001 when co-administered with EFV and 3TC
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
Trough plasma concentration pre-dose (C0) of BMS-986001 when co-administered with EFV and 3TC
Timepoint [8] 0 0
Week 24
Secondary outcome [9] 0 0
Area under the concentration-time curve in one dosing interval [AUC(0-24)] of BMS-986001 when co-administered with EFV and 3TC
Timepoint [9] 0 0
Week 24
Secondary outcome [10] 0 0
Average steady-state plasma concentration (Css,avg) of BMS-986001 when co-administered with EFV and 3TC
Timepoint [10] 0 0
Week 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
297
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - Liverpool
Recruitment hospital [3] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
1871 - Liverpool
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Chile
State/province [15] 0 0
Santiago
Country [16] 0 0
Colombia
State/province [16] 0 0
Cundinamarca
Country [17] 0 0
France
State/province [17] 0 0
Lyon
Country [18] 0 0
Hungary
State/province [18] 0 0
Budapest
Country [19] 0 0
Mexico
State/province [19] 0 0
Distrito Federal
Country [20] 0 0
Peru
State/province [20] 0 0
Lima
Country [21] 0 0
Peru
State/province [21] 0 0
Loreto
Country [22] 0 0
South Africa
State/province [22] 0 0
Free State
Country [23] 0 0
South Africa
State/province [23] 0 0
Gauteng
Country [24] 0 0
South Africa
State/province [24] 0 0
Kwa Zulu Natal
Country [25] 0 0
South Africa
State/province [25] 0 0
Western Cape
Country [26] 0 0
South Africa
State/province [26] 0 0
Cape Town
Country [27] 0 0
South Africa
State/province [27] 0 0
Durban KZN
Country [28] 0 0
South Africa
State/province [28] 0 0
Durban
Country [29] 0 0
Spain
State/province [29] 0 0
Badalona
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Thailand
State/province [32] 0 0
Bangkok
Country [33] 0 0
Thailand
State/province [33] 0 0
Khon Kaen
Country [34] 0 0
Thailand
State/province [34] 0 0
Nontaburi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT01489046
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01489046