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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
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Arkansas
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California
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Colorado
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District of Columbia
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Florida
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Georgia
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Illinois
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Iowa
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Maryland
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Massachusetts
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Minnesota
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Texas
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Utah
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Antwerpen
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Bruxelles
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Gent
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Liege
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Alberta
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British Columbia
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Hvidovre
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Denmark
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Koebenhavn
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Denmark
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Odense
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France
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Nice
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France
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Orléans Cedex 2
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France
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Paris Cedex 20
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France
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Saint Denis Cedex 01
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France
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Strasbourg cedex
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France
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Tourcoing cedex
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Berlin
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Germany
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Hamburg
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Toscana
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Romania
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Bucharest
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Romania
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Constanta
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Spain
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Asturias
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Spain
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(Móstoles) Madrid
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Spain
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Alcala de Henares
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Spain
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Alicante
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Badalona
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Barcelona
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Basurto/Bilbao
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Spain
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Elche (Alicante)
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Spain
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Granada
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Spain
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Granollers (Barcelona)
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Spain
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La Laguna (Santa Cruz De Tenerife)
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Spain
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Logroño
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Spain
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Madrid
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Spain
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Marid
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Spain
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Murcia
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Spain
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Málaga
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Spain
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Palma de Mallorca
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Spain
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Sabadell (Barcelona)
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Spain
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San Sebastián
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Spain
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Santiago de Compostela
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Sevilla
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Spain
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Valencia
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Spain
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Vigo ( Pontevedra)
Country [82] 0 0
United Kingdom
State/province [82] 0 0
London
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United Kingdom
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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
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.
Trial website
https://clinicaltrials.gov/study/NCT01263015
Trial related presentations / publications
Brinson C, Walmsley S, Arasteh K, et al. Dolutegravir treatment response and safety by key subgroups in treatment naive HIV-infected individuals. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.
Walmsley S, Baumgarten A, Berenguer J, Felizarta F, Florence E, Khuong-Josses MA, Kilby JM, Lutz T, Podzamczer D, Portilla J, Roth N, Wong D, Granier C, Wynne B, Pappa K. Brief Report: Dolutegravir Plus Abacavir/Lamivudine for the Treatment of HIV-1 Infection in Antiretroviral Therapy-Naive Patients: Week 96 and Week 144 Results From the SINGLE Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2015 Dec 15;70(5):515-9. doi: 10.1097/QAI.0000000000000790. Erratum In: J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):e33.
Walmsley SL, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutierrez F, Hocqueloux L, Maggiolo F, Sandkovsky U, Granier C, Pappa K, Wynne B, Min S, Nichols G; SINGLE Investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013 Nov 7;369(19):1807-18. doi: 10.1056/NEJMoa1215541.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01263015