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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Terminated
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/ct2/show/NCT01489046
Trial related presentations / publications
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/ct2/show/NCT01489046