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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01231516




Registration number
NCT01231516
Ethics application status
Date submitted
21/10/2010
Date registered
1/11/2010

Titles & IDs
Public title
A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults
Scientific title
A Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered With an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral-Experienced Adults
Secondary ID [1] 0 0
2009-018001-51
Secondary ID [2] 0 0
111762
Universal Trial Number (UTN)
Trial acronym
SAILING
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection, Human Immunodeficiency Virus 0 0
HIV Infections 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
Infection 0 0 0 0
Sexually transmitted infections
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK1349572
Treatment: Drugs - Raltegravir
Treatment: Drugs - GSK1349572 Placebo
Treatment: Drugs - Raltegravir Placebo

Experimental: GSK1349572 + Raltegravir Placebo - Subjects will receive GSK1349572 50mg once daily plus raltegravir placebo twice daily.

Active comparator: Raltegravir + GSK1349572 Placebo - Subjects will receive raltegravir 400mg twice daily plus GSK1349572 placebo once daily.


Treatment: Drugs: GSK1349572
50mg once daily

Treatment: Drugs: Raltegravir
400mg twice daily

Treatment: Drugs: GSK1349572 Placebo
Inactive placebo tablet once daily

Treatment: Drugs: Raltegravir Placebo
Inactive placebo tablet twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48
Timepoint [1] 0 0
At Week 48
Secondary outcome [1] 0 0
Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent Integrase Inhibitor (INI) Resistance at Time of Protocol Defined Virology Failure (PDVF)
Timepoint [1] 0 0
Baseline (Day 1) until PDVF (Up to Week 48)
Secondary outcome [2] 0 0
Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
Timepoint [2] 0 0
At Week 24
Secondary outcome [3] 0 0
Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48
Timepoint [3] 0 0
At Week 24 and Week 48
Secondary outcome [4] 0 0
Absolute Values of Cluster of Differentiation 4+ (CD4+) Cell Counts at Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
Timepoint [4] 0 0
Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
Secondary outcome [5] 0 0
Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12,16, 24, 32, 40, 48, 96 and 144
Timepoint [5] 0 0
Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
Secondary outcome [6] 0 0
Number of Participants With Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions
Timepoint [6] 0 0
Up to Week 480
Secondary outcome [7] 0 0
Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities
Timepoint [7] 0 0
From Baseline (Day 1) until Week 48, including participants with post-treatment events occurring after Week 48 for participants not entering the post-Week 48 Open-Label phase of the study
Secondary outcome [8] 0 0
Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities
Timepoint [8] 0 0
From Week 48 to Week 480
Secondary outcome [9] 0 0
DTG PK Parameters Including Maximum Plasma Drug Concentration (Cmax), Minimal Plasma Drug Concentration (Cmin), and Average Plasma Pre-dose Concentration (C0_avg)
Timepoint [9] 0 0
Pre-dose and at 1 to 3 hours or 4 to 12 hours post-dose at Week 4; Pre-dose at Week 24; Pre-dose and 1 to 3 hours or 4 to 12 hours post-dose at Week 48
Secondary outcome [10] 0 0
DTG PK Parameter Including Pre-dose Concentration (C0)
Timepoint [10] 0 0
Pre-dose at Weeks 4, 24 and 48
Secondary outcome [11] 0 0
DTG PK Parameters Including Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau Over a Dosing Interval at Steady State (AUC[0-tau])
Timepoint [11] 0 0
Pre-dose and at 1 to 3 hours or 4 to 12 hours post-dose at Week 4; Pre-dose at Week 24; Pre-dose and 1 to 3 hours or 4 to 12 hours post-dose at Week 48
Secondary outcome [12] 0 0
Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Utility Score
Timepoint [12] 0 0
Baseline (Day 1) and at Weeks 24 and 48
Secondary outcome [13] 0 0
Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Thermometer Scores
Timepoint [13] 0 0
Baseline (Day 1) and at Weeks 24 and 48

Eligibility
Key inclusion criteria
* Antiretroviral therapy (ART)-experienced, Human Immunodeficiency Virus (HIV) -1 infected adults at least 18 years of age.
* Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol).
* HIV-1 infection as documented by HIV-1 RNA >400 copies/mL (c/mL) at Screening and with at least one consecutive HIV-1 RNA >400 c/mL within the four months prior to Screening (unless the Screening HIV-1 RNA is > 1000 c/mL where no additional plasma HIV-1 RNA assessment is needed).
* Have documented resistance (via Screening resistance test) to two or more different classes of antiretroviral agents. For subjects off ART for at least one month, if Screening resistance results provide a fully active agent and do not show two class resistance then historical resistance results from the subject's most recent resistance testing may be used, following consultation with the study virologist and /or medical monitor.
* Integrase inhibitor (INI)-naïve, defined as no prior exposure to any INI (e.g. RAL, elvitegravir, or GSK1349572).
* Able to provide written informed consent prior to Screening.
* French subjects: In France, subjects will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Screening resistance test result indicates no fully active antiviral agents are available for design of the background regimen.
* Subject-virus does not yield results using genotype/phenotype/tropism at Screening (assay data is essential for eligibility determination).
* Women who are breastfeeding.
* Any evidence of an active AIDS-defining condition (except cutaneous Kaposi's sarcoma not requiring systemic therapy or CD4+ <200c/mm3).
* Subjects with moderate to severe hepatic impairment as defined by Child-Pugh classification.
* Recent history (less than or equal to 3 months) of upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding.
* Anticipated need for hepatitis C therapy during the study.
* History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
* History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma; other localized malignancies require agreement between the investigator and study medical monitor for inclusion of the subject.
* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days prior to Screening.
* Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any immunomodulator.
* Treatment with any agent, other than licensed ART, which has documented activity against HIV-1 in vitro within 28 days of first dose of investigational product.
* Exposure to an experimental drug and/or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the experimental test agent - whichever is longer, prior to the first dose of IP.
* French subjects recruited at sites in France will be excluded if the subject has participated in any study using an investigational drug and/or vaccine within 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine - whichever is longer - prior to screening for the study or the subject plans to participate simultaneously in another clinical study.
* Any acute or verified Grade 4 laboratory abnormality.
* Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN).
* ALT greater than or equal to 3xULN and bilirubin greater than or equal to 1.5xULN (with >35% direct bilirubin).

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/02/2021
Sample size
Target
Accrual to date
Final
724
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
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Rhode Island
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
Argentina
State/province [28] 0 0
Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Santa Fe
Country [30] 0 0
Argentina
State/province [30] 0 0
Ciudad Autonoma de Buenos Aires
Country [31] 0 0
Belgium
State/province [31] 0 0
Antwerpen
Country [32] 0 0
Belgium
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Brussels
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Belgium
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Charleroi
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Belgium
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Liege
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Brazil
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Minas Gerais
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Brazil
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Paraná
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Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Brazil
State/province [40] 0 0
Santos
Country [41] 0 0
Brazil
State/province [41] 0 0
Vitoria
Country [42] 0 0
Canada
State/province [42] 0 0
British Columbia
Country [43] 0 0
Canada
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Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
Chile
State/province [45] 0 0
Región Metro De Santiago
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Chile
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Santiago
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France
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Bordeaux
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France
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Garches
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France
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Le Kremlin Bicêtre cedex
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France
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Le Kremlin-Bicêtre Cedex
Country [51] 0 0
France
State/province [51] 0 0
Marseille
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France
State/province [52] 0 0
Nice
Country [53] 0 0
France
State/province [53] 0 0
Orléans
Country [54] 0 0
France
State/province [54] 0 0
Paris Cedex 10
Country [55] 0 0
France
State/province [55] 0 0
Paris Cedex 13
Country [56] 0 0
France
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Paris Cedex 20
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France
State/province [57] 0 0
Paris
Country [58] 0 0
France
State/province [58] 0 0
Tourcoing cedex
Country [59] 0 0
Greece
State/province [59] 0 0
Athens
Country [60] 0 0
Greece
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Piraeus
Country [61] 0 0
Greece
State/province [61] 0 0
Rio, Patras
Country [62] 0 0
Hungary
State/province [62] 0 0
Budapest
Country [63] 0 0
Italy
State/province [63] 0 0
Emilia-Romagna
Country [64] 0 0
Italy
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Lombardia
Country [65] 0 0
Italy
State/province [65] 0 0
Piemonte
Country [66] 0 0
Italy
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Sardegna
Country [67] 0 0
Mexico
State/province [67] 0 0
Estado De México
Country [68] 0 0
Mexico
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Guanajuato
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Mexico
State/province [69] 0 0
Jalisco
Country [70] 0 0
Mexico
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Mexico City
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Netherlands
State/province [71] 0 0
Amsterdam
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Netherlands
State/province [72] 0 0
Rotterdam
Country [73] 0 0
Poland
State/province [73] 0 0
Chorzow
Country [74] 0 0
Romania
State/province [74] 0 0
Bucharest
Country [75] 0 0
Romania
State/province [75] 0 0
Constanta
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Ekaterinburg
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Kazan
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Krasnodar
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Moscow
Country [80] 0 0
Russian Federation
State/province [80] 0 0
N.Novgorod
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Perm
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Ryazan
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Saint-Petersburg
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Saratov
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Toliyatti
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Volgograd
Country [87] 0 0
South Africa
State/province [87] 0 0
Bloemfontein
Country [88] 0 0
South Africa
State/province [88] 0 0
Dundee
Country [89] 0 0
South Africa
State/province [89] 0 0
Durban
Country [90] 0 0
Spain
State/province [90] 0 0
(Móstoles) Madrid
Country [91] 0 0
Spain
State/province [91] 0 0
Alicante
Country [92] 0 0
Spain
State/province [92] 0 0
Badalona
Country [93] 0 0
Spain
State/province [93] 0 0
Barcelona
Country [94] 0 0
Spain
State/province [94] 0 0
Cartagena (Murcia)
Country [95] 0 0
Spain
State/province [95] 0 0
Elche (Alicante)
Country [96] 0 0
Spain
State/province [96] 0 0
Granada
Country [97] 0 0
Spain
State/province [97] 0 0
Granollers (Barcelona)
Country [98] 0 0
Spain
State/province [98] 0 0
La Coruña
Country [99] 0 0
Spain
State/province [99] 0 0
Madrid
Country [100] 0 0
Spain
State/province [100] 0 0
Mataró
Country [101] 0 0
Spain
State/province [101] 0 0
Murcia
Country [102] 0 0
Spain
State/province [102] 0 0
Sabadell (Barcelona)
Country [103] 0 0
Spain
State/province [103] 0 0
San Sebastián
Country [104] 0 0
Spain
State/province [104] 0 0
Sevilla
Country [105] 0 0
Spain
State/province [105] 0 0
Valencia
Country [106] 0 0
Taiwan
State/province [106] 0 0
Kaohsiung
Country [107] 0 0
Taiwan
State/province [107] 0 0
Taichung
Country [108] 0 0
Taiwan
State/province [108] 0 0
Taipei
Country [109] 0 0
United Kingdom
State/province [109] 0 0
London
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Crumpsall, Manchester
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Liverpool
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Tooting, London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ViiV Healthcare
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Shionogi
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
GlaxoSmithKline
Address [2] 0 0
Country [2] 0 0

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


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/NCT01231516