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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02362503




Registration number
NCT02362503
Ethics application status
Date submitted
9/02/2015
Date registered
13/02/2015
Date last updated
23/07/2024

Titles & IDs
Public title
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
Scientific title
A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir (BMS-663068/GSK3684934) in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1 (BRIGHTE Study)
Secondary ID [1] 0 0
AI438-047
Secondary ID [2] 0 0
205888
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-663068
Other interventions - Placebo

Experimental: A1: BMS-663068 - Phase 1: BMS-663068 600 mg tablets orally twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.

Active comparator: B1: Placebo + BMS-663068 - Phase 1: Placebo twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.

Experimental: BMS-663068 - BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.


Treatment: Drugs: BMS-663068
BMS-663068

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort
Timepoint [1] 0 0
Day 1 and Day 8
Secondary outcome [1] 0 0
Percentage of Participants With HIV-1 RNA Decreases From Day 1 That Exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8-Randomized Cohort
Timepoint [1] 0 0
Day 1 and Day 8
Secondary outcome [2] 0 0
Percentage of Participants With HIV-1 RNA <40 c/mL at Weeks 24, 48 and 96-Randomized Cohort
Timepoint [2] 0 0
At Weeks 24, 48 and 96
Secondary outcome [3] 0 0
Number of Participants With On-treatment Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Randomized Cohort
Timepoint [3] 0 0
Up to Week 96 analysis cut-off date
Secondary outcome [4] 0 0
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Timepoint [4] 0 0
Baseline and up to Week 96 analysis cut-off date
Secondary outcome [5] 0 0
Number of Participants With Toxicity Grade Increase in Hematology Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Timepoint [5] 0 0
Baseline and up to Week 96 analysis cut-off date
Secondary outcome [6] 0 0
Number of Participants With Centers for Disease Control (CDC) Class C Events-Randomized Cohort
Timepoint [6] 0 0
Up to Week 96 analysis cut-off date
Secondary outcome [7] 0 0
Change From Day 1 in Cluster of Differentiation (CD) 4+ T-cell Count at Day 8-Randomized Cohort
Timepoint [7] 0 0
Day 1 and Day 8
Secondary outcome [8] 0 0
Change in CD4+ T- Cell Count Percentage From Day 1 at Day 8-Randomized Cohort
Timepoint [8] 0 0
Day 1 and Day 8
Secondary outcome [9] 0 0
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Timepoint [9] 0 0
Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96
Secondary outcome [10] 0 0
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
Timepoint [10] 0 0
Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96
Secondary outcome [11] 0 0
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Timepoint [11] 0 0
Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96
Secondary outcome [12] 0 0
Number of Participants With Treatment-emergent Viral Genotypic Substitution of Interest in the GP160 Domain as a Measure of Genotypic Resistance-Randomized Cohort
Timepoint [12] 0 0
Week 96
Secondary outcome [13] 0 0
Number of Participants With Indicated Fold Change Ratio (FCR) Using the Monogram PhenoSense Entry Assay-Randomized Cohort
Timepoint [13] 0 0
Week 96

Eligibility
Key inclusion criteria
* Men and non-pregnant women with chronic HIV-1 infection
* Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes
* Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA = 400 c/mL (first value from Investigator, second from Screening labs)
* Must have = 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety
* Able to receive = 1 fully active approved antiretroviral as part of the OBT from Day 9 onwards in the Randomized Cohort
* Subjects without any remaining fully active approved antiretroviral may be enrolled in the Non-Randomized Cohort
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV are eligible)
* HIV-2 infection
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 7 x ULN
* Alkaline Phosphatase > 5 x ULN
* Bilirubin = 1.5 x Upper limit of normal (ULN) (unless subject is currently on atazanavir and has predominantly unconjugated hyperbilirubinemia)

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
Accrual to date
Final
371
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Córdova
Country [21] 0 0
Argentina
State/province [21] 0 0
Santa Fe
Country [22] 0 0
Belgium
State/province [22] 0 0
Antwerpen
Country [23] 0 0
Belgium
State/province [23] 0 0
Brussels
Country [24] 0 0
Brazil
State/province [24] 0 0
Paraná
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio Grande Do Sul
Country [26] 0 0
Brazil
State/province [26] 0 0
São Paulo
Country [27] 0 0
Brazil
State/province [27] 0 0
Belo Horizonte
Country [28] 0 0
Brazil
State/province [28] 0 0
Ribeirao Preto
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio de Janeiro
Country [30] 0 0
Brazil
State/province [30] 0 0
Salvador
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Canada
State/province [31] 0 0
British Columbia
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Canada
State/province [32] 0 0
Ontario
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Canada
State/province [33] 0 0
Quebec
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Canada
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Vancouver
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Chile
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Región Metro De Santiago
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Chile
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Santiago
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Chile
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Temuco
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Colombia
State/province [38] 0 0
Bogota
Country [39] 0 0
Colombia
State/province [39] 0 0
Bogotá
Country [40] 0 0
Colombia
State/province [40] 0 0
Cali, Valle Del Cauca
Country [41] 0 0
France
State/province [41] 0 0
Bordeaux cedex
Country [42] 0 0
France
State/province [42] 0 0
Marseille
Country [43] 0 0
France
State/province [43] 0 0
Nantes
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France
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Paris cedex 10
Country [45] 0 0
France
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Paris Cedex 12
Country [46] 0 0
France
State/province [46] 0 0
Paris cedex 20
Country [47] 0 0
France
State/province [47] 0 0
Paris
Country [48] 0 0
Germany
State/province [48] 0 0
Baden-Wuerttemberg
Country [49] 0 0
Germany
State/province [49] 0 0
Hessen
Country [50] 0 0
Germany
State/province [50] 0 0
Nordrhein-Westfalen
Country [51] 0 0
Germany
State/province [51] 0 0
Berlin
Country [52] 0 0
Germany
State/province [52] 0 0
München
Country [53] 0 0
Greece
State/province [53] 0 0
Athens
Country [54] 0 0
Greece
State/province [54] 0 0
Thessaloniki
Country [55] 0 0
Ireland
State/province [55] 0 0
Dublin
Country [56] 0 0
Italy
State/province [56] 0 0
Lazio
Country [57] 0 0
Italy
State/province [57] 0 0
Lombardia
Country [58] 0 0
Italy
State/province [58] 0 0
Piemonte
Country [59] 0 0
Italy
State/province [59] 0 0
Modena
Country [60] 0 0
Italy
State/province [60] 0 0
Monza
Country [61] 0 0
Mexico
State/province [61] 0 0
Estado De México
Country [62] 0 0
Mexico
State/province [62] 0 0
Jalisco
Country [63] 0 0
Mexico
State/province [63] 0 0
Chihuahua
Country [64] 0 0
Mexico
State/province [64] 0 0
Ciudad de Mexico
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Mexico
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Distrito Federal
Country [66] 0 0
Mexico
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Mexico
Country [67] 0 0
Netherlands
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Utrecht
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Peru
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Loreto
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Peru
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Lima
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Poland
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Szczecin
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Poland
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Warszawa
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Portugal
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Lisboa
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Portugal
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Lisbon
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Puerto Rico
State/province [74] 0 0
San Juan
Country [75] 0 0
Romania
State/province [75] 0 0
Bucharest
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Irkutsk
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Krasnodar
Country [78] 0 0
South Africa
State/province [78] 0 0
Eastern Cape
Country [79] 0 0
South Africa
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Free State
Country [80] 0 0
South Africa
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Gauteng
Country [81] 0 0
South Africa
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KwaZulu- Natal
Country [82] 0 0
South Africa
State/province [82] 0 0
Western Province
Country [83] 0 0
South Africa
State/province [83] 0 0
Cape Town
Country [84] 0 0
South Africa
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Durban
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Spain
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Badalona, Barcelona
Country [86] 0 0
Spain
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Barcelona
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Spain
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Madrid
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Spain
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Seville, Sevilla
Country [89] 0 0
Taiwan
State/province [89] 0 0
Taipei
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Bournemouth
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Leicestershire
Country [92] 0 0
United Kingdom
State/province [92] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ViiV Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
ViiV Healthcare
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02362503