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A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)

NCT ID: NCT01263015

Last Updated: 2018-04-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

844 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-01

Study Completion Date

2015-12-03

Brief Summary

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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.

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A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen

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Detailed Description

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ING114467 is a Phase 3 randomized, double-blind, double dummy, active-controlled, multicenter, study conducted in approximately 788 HIV-1 infected ART-naïve subjects. Subjects will be randomized 1:1 one of the following treatment arms:

GSK1349572 50 mg plus abacavir/lamivudine fixed-dose combination once daily (approximately 394 subjects)

OR

Atripla once daily (approximately 394 subjects)

Analyses will be conducted at 48 weeks and 96 weeks. Subjects randomized to receive GSK1349572 and who successfully complete 96 weeks of treatment will continue to have access to GSK1349572 plus abacavir/lamivudine fixed-dose combination through the study until it is locally available-as long as they continue to derive clinical benefit, until they meet a protocol-defined reason for discontinuation, or until development of the compound is terminated.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Conditions

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Infection, Human Immunodeficiency Virus I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dolutegravir (N=~394):

Dolutegravir 50mg once daily + abacavir/lamivudine as the fixed-dose combination once daily + Atripla placebo once daily

Group Type EXPERIMENTAL

Dolutegravir

Intervention Type DRUG

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

Abacavir/Lamivudine

Intervention Type DRUG

taken once daily; also known as EPZICOM

Atripla placebo

Intervention Type DRUG

matching placebo taken once daily on an empty stomach

Atripla (N=~394):

Atripla once daily + Dolutegravir placebo once daily + abacavir/lamivudine as the fixed-dose combination placebo once daily

Group Type ACTIVE_COMPARATOR

Atripla

Intervention Type DRUG

Atripla once daily on an empty stomach

Abacavir/Lamivudine Placebo

Intervention Type DRUG

matching placebo taken once daily

Dolutegravir placebo

Intervention Type DRUG

matching placebo taken once daily

Interventions

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Dolutegravir

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

Intervention Type DRUG

Atripla

Atripla once daily on an empty stomach

Intervention Type DRUG

Abacavir/Lamivudine

taken once daily; also known as EPZICOM

Intervention Type DRUG

Abacavir/Lamivudine Placebo

matching placebo taken once daily

Intervention Type DRUG

Dolutegravir placebo

matching placebo taken once daily

Intervention Type DRUG

Atripla placebo

matching placebo taken once daily on an empty stomach

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shionogi

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

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GSK Investigational Site

Hobson City, Alabama, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Beverly Hills, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Oakland, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Fort Lauderdale, Florida, United States

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Ft. Pierce, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Orlando, Florida, United States

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West Palm Beach, Florida, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Maywood, Illinois, United States

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Iowa City, Iowa, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Newark, New Jersey, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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Salt Lake City, Utah, United States

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Darlinghurst, Sydney, New South Wales, Australia

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Carlton, Victoria, Australia

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Fitzroy North, Victoria, Australia

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Prahran, Victoria, Australia

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Antwerp, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Liège, , Belgium

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Copenhagen, , Denmark

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Hvidovre, , Denmark

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Odense, , Denmark

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Nice, , France

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Orléans, , France

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Paris, , France

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Saint-Denis, , France

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Strasbourg, , France

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Tourcoing, , France

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Stuttgart, Baden-Wurttemberg, Germany

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Munich, Bavaria, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Berlin, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Ravenna, Emilia-Romagna, Italy

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Rome, Lazio, Italy

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Genoa, Liguria, Italy

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Bergamo, Lombardy, Italy

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Milan, Lombardy, Italy

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Bagno A Ripoli (FI), Tuscany, Italy

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Rotterdam, , Netherlands

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Rotterdam, , Netherlands

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Utrecht, , Netherlands

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Bucharest, , Romania

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Bucharest, , Romania

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Constanța, , Romania

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Oviedo, Principality of Asturias, Spain

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(Móstoles) Madrid, , Spain

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Alcalá de Henares, , Spain

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Alicante, , Spain

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Badalona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Basurto/Bilbao, , Spain

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Elche (Alicante), , Spain

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Granada, , Spain

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Granollers (Barcelona), , Spain

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La Laguna (Santa Cruz de Tenerife), , Spain

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Logroño, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Marid, , Spain

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Málaga, , Spain

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Murcia, , Spain

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Palma de Mallorca, , Spain

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Sabadell (Barcelona), , Spain

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San Sebastián, , Spain

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Santiago de Compostela, , Spain

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Seville, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Vigo ( Pontevedra), , Spain

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Woolwich, London, London, United Kingdom

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Birmingham, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Tooting, London, , United Kingdom

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Countries

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United States Australia Belgium Canada Denmark France Germany Italy Netherlands Romania Spain United Kingdom

References

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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.

Reference Type BACKGROUND

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.

Reference Type DERIVED
PMID: 26262777 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24195548 (View on PubMed)

Other Identifiers

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114467

Identifier Type: -

Identifier Source: org_study_id

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