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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01263015




Registration number
NCT01263015
Ethics application status
Date submitted
16/12/2010
Date registered
20/12/2010
Date last updated
4/04/2018

Titles & IDs
Public title
A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)
Scientific title
A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects
Secondary ID [1] 0 0
114467
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection, Human Immunodeficiency Virus I 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 - Dolutegravir
Treatment: Drugs - Atripla
Treatment: Drugs - Abacavir/Lamivudine
Treatment: Drugs - Abacavir/Lamivudine Placebo
Treatment: Drugs - Dolutegravir placebo
Treatment: Drugs - Atripla placebo

Experimental: Dolutegravir (N=~394): - Dolutegravir 50mg once daily + abacavir/lamivudine as the fixed-dose combination once daily + Atripla placebo once daily

Active comparator: Atripla (N=~394): - Atripla once daily + Dolutegravir placebo once daily + abacavir/lamivudine as the fixed-dose combination placebo once daily


Treatment: Drugs: Dolutegravir
Dolutegravir (also known as GSK1349572) 50 mg taken once daily

Treatment: Drugs: Atripla
Atripla once daily on an empty stomach

Treatment: Drugs: Abacavir/Lamivudine
taken once daily; also known as EPZICOM

Treatment: Drugs: Abacavir/Lamivudine Placebo
matching placebo taken once daily

Treatment: Drugs: Dolutegravir placebo
matching placebo taken once daily

Treatment: Drugs: Atripla placebo
matching placebo taken once daily on an empty stomach
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Time to Viral Suppression (<50 c/mL)
Timepoint [1] 0 0
From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)
Secondary outcome [2] 0 0
Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144
Timepoint [2] 0 0
Week 96 and Week 144
Secondary outcome [3] 0 0
Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24
Timepoint [3] 0 0
From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)
Secondary outcome [4] 0 0
Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144
Timepoint [4] 0 0
Baseline and at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144
Secondary outcome [5] 0 0
Change From Baseline in CD4+ Cell Counts at Week 144
Timepoint [5] 0 0
Baseline and Week 144
Secondary outcome [6] 0 0
Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144
Timepoint [6] 0 0
Baseline and Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144
Secondary outcome [7] 0 0
Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144
Timepoint [7] 0 0
From Baseline until Week 144
Secondary outcome [8] 0 0
Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144
Timepoint [8] 0 0
From Baseline until Week 144
Secondary outcome [9] 0 0
Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144
Timepoint [9] 0 0
Through Week 144
Secondary outcome [10] 0 0
Change From Baseline in the Symptom Bother Score (SBS) at Week 4 Through Week 48
Timepoint [10] 0 0
Baseline and Week 4 through 48

Eligibility
Key inclusion criteria
* Screening plasma HIV-1 RNA =1000 c/mL
* Antiretroviral-naïve (= 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection)
* Ability to understand and sign a written informed consent form
* Willingness to use approved methods of contraception to avoid pregnancy (women of child bearing potential only)
* Age equal to or greater than 18 years
* A negative HLAB*5701 allele assessment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant or breastfeeding;
* Active Center for Disease and Prevention Control (CDC) Category C disease
* Hepatic impairment
* HBV co-infection
* Anticipated need for HCV therapy during the study
* Allergy or intolerance to the study drugs or their components or drugs of their class
* Malignancy within the past 5 years
* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
* Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening
* Exposure to an agent with documented activity against HIV-1 in vitro or an experimental vaccine or drug within 28 days of first dose of study medication
* Primary viral resistance in the Screening result
* Verified Grade 4 laboratory abnormality
* ALT >5 xULN
* ALT = 3xULN and bilirubin = 1.5xULN (with >35% direct bilirubin);
* Estimated creatinine clearance <50 mL/min
* Recent history (=3 months) of upper or lower gastrointestinal bleed

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
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/12/2015
Sample size
Target
Accrual to date
Final
844
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst, Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Carlton
Recruitment hospital [3] 0 0
GSK Investigational Site - North Fitzroy
Recruitment hospital [4] 0 0
GSK Investigational Site - Prahran
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst, Sydney
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
3078 - North Fitzroy
Recruitment postcode(s) [4] 0 0
3181 - Prahran
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
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
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Rhode Island
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
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United States of America
State/province [24] 0 0
Utah
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Belgium
State/province [25] 0 0
Antwerpen
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
State/province [28] 0 0
Liege
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Canada
State/province [29] 0 0
Alberta
Country [30] 0 0
Canada
State/province [30] 0 0
British Columbia
Country [31] 0 0
Canada
State/province [31] 0 0
Manitoba
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
Denmark
State/province [34] 0 0
Hvidovre
Country [35] 0 0
Denmark
State/province [35] 0 0
Koebenhavn
Country [36] 0 0
Denmark
State/province [36] 0 0
Odense
Country [37] 0 0
France
State/province [37] 0 0
Nice
Country [38] 0 0
France
State/province [38] 0 0
Orléans Cedex 2
Country [39] 0 0
France
State/province [39] 0 0
Paris Cedex 20
Country [40] 0 0
France
State/province [40] 0 0
Saint Denis Cedex 01
Country [41] 0 0
France
State/province [41] 0 0
Strasbourg cedex
Country [42] 0 0
France
State/province [42] 0 0
Tourcoing cedex
Country [43] 0 0
Germany
State/province [43] 0 0
Baden-Wuerttemberg
Country [44] 0 0
Germany
State/province [44] 0 0
Bayern
Country [45] 0 0
Germany
State/province [45] 0 0
Hessen
Country [46] 0 0
Germany
State/province [46] 0 0
Niedersachsen
Country [47] 0 0
Germany
State/province [47] 0 0
Nordrhein-Westfalen
Country [48] 0 0
Germany
State/province [48] 0 0
Berlin
Country [49] 0 0
Germany
State/province [49] 0 0
Hamburg
Country [50] 0 0
Italy
State/province [50] 0 0
Emilia-Romagna
Country [51] 0 0
Italy
State/province [51] 0 0
Lazio
Country [52] 0 0
Italy
State/province [52] 0 0
Liguria
Country [53] 0 0
Italy
State/province [53] 0 0
Lombardia
Country [54] 0 0
Italy
State/province [54] 0 0
Toscana
Country [55] 0 0
Netherlands
State/province [55] 0 0
Rotterdam
Country [56] 0 0
Netherlands
State/province [56] 0 0
Utrecht
Country [57] 0 0
Romania
State/province [57] 0 0
Bucharest
Country [58] 0 0
Romania
State/province [58] 0 0
Constanta
Country [59] 0 0
Spain
State/province [59] 0 0
Asturias
Country [60] 0 0
Spain
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(Móstoles) Madrid
Country [61] 0 0
Spain
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Alcala de Henares
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Spain
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Alicante
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Spain
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Badalona
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Spain
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Barcelona
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Spain
State/province [65] 0 0
Basurto/Bilbao
Country [66] 0 0
Spain
State/province [66] 0 0
Elche (Alicante)
Country [67] 0 0
Spain
State/province [67] 0 0
Granada
Country [68] 0 0
Spain
State/province [68] 0 0
Granollers (Barcelona)
Country [69] 0 0
Spain
State/province [69] 0 0
La Laguna (Santa Cruz De Tenerife)
Country [70] 0 0
Spain
State/province [70] 0 0
Logroño
Country [71] 0 0
Spain
State/province [71] 0 0
Madrid
Country [72] 0 0
Spain
State/province [72] 0 0
Marid
Country [73] 0 0
Spain
State/province [73] 0 0
Murcia
Country [74] 0 0
Spain
State/province [74] 0 0
Málaga
Country [75] 0 0
Spain
State/province [75] 0 0
Palma de Mallorca
Country [76] 0 0
Spain
State/province [76] 0 0
Sabadell (Barcelona)
Country [77] 0 0
Spain
State/province [77] 0 0
San Sebastián
Country [78] 0 0
Spain
State/province [78] 0 0
Santiago de Compostela
Country [79] 0 0
Spain
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Sevilla
Country [80] 0 0
Spain
State/province [80] 0 0
Valencia
Country [81] 0 0
Spain
State/province [81] 0 0
Vigo ( Pontevedra)
Country [82] 0 0
United Kingdom
State/province [82] 0 0
London
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Birmingham
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Liverpool
Country [85] 0 0
United Kingdom
State/province [85] 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

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/NCT01263015