A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily

Last updated: October 4, 2018
Sponsor: ViiV Healthcare
Overall Status: Completed

Phase

3

Condition

Aids And Aids Related Infections

Hiv Infections

Hiv/aids

Treatment

N/A

Clinical Study ID

NCT01227824
113086
  • Ages > 18
  • All Genders

Study Summary

The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult subjects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Screening plasma HIV-1 RNA ≥1000 c/mL

  • Antiretroviral-naïve (≤ 10 days of prior therapy with any antiretroviral agentfollowing 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 ofchild bearing potential only)

  • Age equal to or greater than 18 years

Exclusion

Exclusion Criteria:

  • Women who are pregnant or breastfeeding;

  • Active Center for Disease and Prevention Control (CDC) Category C disease

  • Moderate to severe hepatic impairment

  • 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 anyimmunomodulator within 28 days of Screening

  • Exposure to an agent with documented activity against HIV-1 in vitro or anexperimental 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

Total Participants: 828
Study Start date:
October 19, 2010
Estimated Completion Date:
December 27, 2016

Study Description

ING113086 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:

  1. GSK1349572 50 mg once daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC)

    OR

  2. 400 mg RAL twice daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC)

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 through the study until either it is locally available, as long as they continue to derive clinical benefit.

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

Connect with a study center

  • GSK Investigational Site

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • GSK Investigational Site

    Surry Hills, New South Wales 2010
    Australia

    Site Not Available

  • GSK Investigational Site

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • GSK Investigational Site

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Site Not Available

  • GSK Investigational Site

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • GSK Investigational Site

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • GSK Investigational Site

    Toronto, Ontario M4T 3A7
    Canada

    Site Not Available

  • GSK Investigational Site

    Montreal, Quebec H2L 5B1
    Canada

    Site Not Available

  • GSK Investigational Site

    Garches, 92380
    France

    Site Not Available

  • GSK Investigational Site

    Le Kremlin Bicêtre cedex, 94275
    France

    Site Not Available

  • GSK Investigational Site

    Le Kremlin Bicêtre cedex, 94275
    France

    Site Not Available

  • GSK Investigational Site

    Levallois Perret, 92300
    France

    Site Not Available

  • GSK Investigational Site

    Lyon Cedex 03, 69437
    France

    Site Not Available

  • GSK Investigational Site

    Marseille, 13003
    France

    Site Not Available

  • GSK Investigational Site

    Nantes, 44093
    France

    Site Not Available

  • GSK Investigational Site

    Paris, 75018
    France

    Site Not Available

  • GSK Investigational Site

    Paris Cedex 10, 75475
    France

    Site Not Available

  • GSK Investigational Site

    Paris Cedex 12, 75571
    France

    Site Not Available

  • GSK Investigational Site

    Paris Cedex 13, 75651
    France

    Site Not Available

  • GSK Investigational Site

    Paris Cedex 4, 75181
    France

    Site Not Available

  • GSK Investigational Site

    Fuerth, Bayern 90762
    Germany

    Site Not Available

  • GSK Investigational Site

    Muenchen, Bayern 80335
    Germany

    Site Not Available

  • GSK Investigational Site

    Frankfurt, Hessen 60596
    Germany

    Site Not Available

  • GSK Investigational Site

    Hannover, Niedersachsen 30625
    Germany

    Site Not Available

  • GSK Investigational Site

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • GSK Investigational Site

    Dortmund, Nordrhein-Westfalen 44137
    Germany

    Site Not Available

  • GSK Investigational Site

    Koeln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • GSK Investigational Site

    Berlin, 13353
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg, 20146
    Germany

    Site Not Available

  • GSK Investigational Site

    Cona (Ferrara), Emilia-Romagna 44124
    Italy

    Site Not Available

  • GSK Investigational Site

    Ferrara, Emilia-Romagna 44100
    Italy

    Site Not Available

  • GSK Investigational Site

    Roma, Lazio 00168
    Italy

    Site Not Available

  • GSK Investigational Site

    Genova, Liguria 16128
    Italy

    Site Not Available

  • GSK Investigational Site

    Brescia, Lombardia 25123
    Italy

    Site Not Available

  • GSK Investigational Site

    Torino, Piemonte 10149
    Italy

    Site Not Available

  • GSK Investigational Site

    Rovigo, Veneto 45100
    Italy

    Site Not Available

  • GSK Investigational Site

    Krasnodar, 350015
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Lipetsk, 398043
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Moscow, 105275
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    N.Novgorod, 603005
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Orel, 302040
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Perm, 614088
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Saratov, 410009
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Smolensk, 214006
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    St. Petersburg, 190103
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    Volgograd, 400040
    Russian Federation

    Site Not Available

  • GSK Investigational Site

    (Móstoles) Madrid, 28935
    Spain

    Site Not Available

  • GSK Investigational Site

    (Móstoles) Madrid, 28935
    Spain

    Site Not Available

  • GSK Investigational Site

    Alcala de Henares, 28805
    Spain

    Site Not Available

  • GSK Investigational Site

    Alicante, 03010
    Spain

    Site Not Available

  • GSK Investigational Site

    Almería, 04009
    Spain

    Site Not Available

  • GSK Investigational Site

    Almería, 04009
    Spain

    Site Not Available

  • GSK Investigational Site

    Badalona, 08916
    Spain

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08036
    Spain

    Site Not Available

  • GSK Investigational Site

    Cartagena (Murcia), 30202
    Spain

    Site Not Available

  • GSK Investigational Site

    Córdoba, 14004
    Spain

    Site Not Available

  • GSK Investigational Site

    Córdoba, 14004
    Spain

    Site Not Available

  • GSK Investigational Site

    Granada,
    Spain

    Site Not Available

  • GSK Investigational Site

    La Coruña, 15006
    Spain

    Site Not Available

  • GSK Investigational Site

    La Coruña, 15006
    Spain

    Site Not Available

  • GSK Investigational Site

    La Laguna (Santa Cruz De Tenerife), 38320
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28006
    Spain

    Site Not Available

  • GSK Investigational Site

    Malaga, 29010
    Spain

    Site Not Available

  • GSK Investigational Site

    Mataró, 08304
    Spain

    Site Not Available

  • GSK Investigational Site

    Mataró, 08304
    Spain

    Site Not Available

  • GSK Investigational Site

    Murcia,
    Spain

    Site Not Available

  • GSK Investigational Site

    San Sebastián, 20014
    Spain

    Site Not Available

  • GSK Investigational Site

    San Sebastián, 20014
    Spain

    Site Not Available

  • GSK Investigational Site

    Sevilla, 41071
    Spain

    Site Not Available

  • GSK Investigational Site

    Valencia, 46010
    Spain

    Site Not Available

  • GSK Investigational Site

    Vigo ( Pontevedra), 36204
    Spain

    Site Not Available

  • GSK Investigational Site

    Birmingham, Warwickshire B29 6JD
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Brighton, BN2 1ES
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Crumpsall, Manchester, M8 5RB
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    London, SW10 9TH
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • GSK Investigational Site

    Little Rock, Arkansas 72207
    United States

    Site Not Available

  • GSK Investigational Site

    Long Beach, California 90813
    United States

    Site Not Available

  • GSK Investigational Site

    Los Angeles, California 90048
    United States

    Site Not Available

  • GSK Investigational Site

    Torrance, California 90502
    United States

    Site Not Available

  • GSK Investigational Site

    Denver, Colorado 80209
    United States

    Site Not Available

  • GSK Investigational Site

    Washington, District of Columbia 20009
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Lauderdale, Florida 33316
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • GSK Investigational Site

    Atlanta, Georgia 30339
    United States

    Site Not Available

  • GSK Investigational Site

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • GSK Investigational Site

    St. Louis, Missouri 63108
    United States

    Site Not Available

  • GSK Investigational Site

    Hillsborough, New Jersey 08844
    United States

    Site Not Available

  • GSK Investigational Site

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • GSK Investigational Site

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • GSK Investigational Site

    Austin, Texas 78705
    United States

    Site Not Available

  • GSK Investigational Site

    Dallas, Texas 75246
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77098
    United States

    Site Not Available

  • GSK Investigational Site

    Seattle, Washington 98104
    United States

    Site Not Available

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