Active, not recruiting

Study Description:

ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.

Viiv Study ID:

111762


Has Results Document Available
Clinicaltrials.gov Identifier:

NCT01231516


EudraCT Number:

2009-018001-51


Study Overview

Medical Conditions

Human Immunodeficiency Virus (HIV)

Product

dolutegravir;raltegravir

Collaborators

Shionogi


Date

October 2010 to December 2019

Type

Interventional

Phase

3


Gender

All

Age

18 years - N/A

Accepts Healthy Volunteers

No


Study Documents

This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

Argentina, Ciudad Autonoma de Buenos Aires C1181ACHCompleted
Argentina, Buenos Aires, Buenos Aires 1141Completed
Argentina, Buenos Aires, Ciudad Autonoma de Buenos Aires C1264AAJCompleted
Argentina, Buenos Aires, Ciudad Autónoma de Buenos Aires C1405CKCCompleted
Argentina, Buenos Aires, Ciudad de Buenos Aires C1202ABBCompleted
Argentina, Santa Fe, Rosario 2000Completed
Australia, New South Wales, Darlinghurst 2010Completed
Australia, Victoria, Melbourne 3004Completed
Belgium, Antwerpen 2000Completed
Belgium, Brussels 1000Completed
Belgium, Charleroi 6000Completed
Belgium, Liege 4000Completed
Brazil, Rio de Janeiro 21040-360Completed
Brazil, Salvador 40110-060Completed
Brazil, Santos 11045-904Completed
Brazil, Vitoria 29041-091Completed
Brazil, Minas Gerais, Belo Horizonte 30130100Completed
Brazil, Paraná, Curitiba 80240-280Completed
Brazil, São Paulo, Sao Paulo 04040-002Completed
Brazil, São Paulo, Sao Paulo 01246-090Completed
Brazil, São Paulo, São Paulo 04121-000Completed
Canada, British Columbia, Vancouver V6Z 2C7Completed
Canada, Ontario, Hamilton L8N 3Z5Completed
Canada, Ontario, Toronto M5G 2N2Completed
Canada, Ontario, Toronto M4T 3A7Completed
Canada, Québec, Montreal H2W 1T8Completed
Canada, Québec, Montreal H2L 5B1Completed
Chile, Santiago 8360159Completed
Chile, Región Metro De Santiago, Puente Alto - Santiago 8207257Completed
Chile, Región Metro De Santiago, Santiago Completed
Chile, Región Metro De Santiago, Santiago 8330074Completed
France, Bordeaux 33000Completed
France, Garches 92380Completed
France, Le Kremlin Bicêtre cedex 94275Completed
France, Le Kremlin-Bicêtre Cedex 94275Completed
France, Marseille 13009Completed
France, Nice 06202Completed
France, Orléans 45100Completed
France, Paris 75018Completed
France, Paris Cedex 10 75475Completed
France, Paris Cedex 13 75651Completed
France, Paris Cedex 20 75970Completed
France, Tourcoing cedex 59208Completed
Greece, Athens 161 21Completed
Greece, Athens 11527Completed
Greece, Piraeus 18536Completed
Greece, Rio, Patras 26504Completed
Hungary, Budapest 1097Completed
Italy, Emilia-Romagna, Modena 41100Completed
Italy, Lombardia, Busto Arsizio (VA) 21052Completed
Italy, Lombardia, Milano 20127Completed
Italy, Lombardia, Monza 20900Completed
Italy, Piemonte, Torino 10149Completed
Italy, Sardegna, Cagliari 09121Completed
Mexico, Mexico City 03720Completed
Mexico, Estado de México, Cuautitlán, Estado de México 54800Completed
Mexico, Guanajuato, León, Guanajuato 37320Completed
Mexico, Jalisco, Guadalajara 44280Completed
Netherlands, AMSTERDAM 1105 AZCompleted
Netherlands, ROTTERDAM 3079 DZCompleted
Poland, Chorzow 41-500Completed
Romania, Bucharest 021105Completed
Romania, Bucharest 030303Completed
Romania, Constanta 900709Completed
Russia, Ekaterinburg 620149Completed
Russia, Kazan 420097Completed
Russia, Krasnodar 350015Completed
Russia, Moscow 105275Completed
Russia, Moscow 129110Completed
Russia, N.Novgorod 603005Completed
Russia, Perm 614088Completed
Russia, Ryazan 390046Completed
Russia, Saratov 410009Completed
Russia, St. Petersburg 190103Completed
Russia, Toliyatti 445846Completed
Russia, Volgograd 400040Completed
South Africa, Bloemfontein 9301Active, not recruiting
South Africa, Dundee 3000Completed
South Africa, Durban 4001Active, not recruiting
Spain, (Móstoles) Madrid 28935Completed
Spain, Alicante 03010Completed
Spain, Badalona 08916Completed
Spain, Barcelona 08036Completed
Spain, Barcelona 08025Completed
Spain, Barcelona 08035Completed
Spain, Cartagena (Murcia) 30202Completed
Spain, Elche (Alicante) 03202Completed
Spain, Granada 18003Completed
Spain, Granada 18014Completed
Spain, Granollers (Barcelona) 08400Completed
Spain, La Coruña 15006Completed
Spain, Madrid 28006Completed
Spain, Madrid 28040Completed
Spain, Madrid 28046Completed
Spain, Madrid 28029Completed
Spain, Mataró 08304Completed
Spain, Murcia Completed
Spain, Sabadell (Barcelona) 08208Completed
Spain, San Sebastián 20014Completed
Spain, Sevilla 41013Completed
Spain, Sevilla 41007Completed
Spain, Valencia 46010Completed
Spain, Valencia 46015Completed
Taiwan, Kaohsiung 813Completed
Taiwan, Kaohsiung 824Completed
Taiwan, Taichung 404Completed
Taiwan, Taichung 406Completed
Taiwan, Taipei 11217Completed
United Kingdom, Crumpsall, Manchester M8 5RBCompleted
United Kingdom, Liverpool L7 8XPCompleted
United Kingdom, Tooting, London SW17 0QTCompleted
United Kingdom, London, Woolwich, London SE18 4QHCompleted
United States, Alabama, Birmingham 35294Completed
United States, Arizona, Phoenix 85012Completed
United States, Arkansas, Little Rock 72207Completed
United States, California, Bakersfield 93301Completed
United States, California, Beverly Hills 90211Completed
United States, California, Long Beach 90813Completed
United States, California, Los Angeles 90036Completed
United States, California, Los Angeles 90048Completed
United States, California, Los Angeles 90069Completed
United States, California, Oakland 94609Completed
United States, Connecticut, New Haven 06520Completed
United States, Connecticut, Norwalk 06850Completed
United States, District of Columbia, Washington 20007Completed
United States, District of Columbia, Washington 20009Completed
United States, Florida, Daytona Beach 32117Completed
United States, Florida, Fort Lauderdale 33316Completed
United States, Florida, Fort Lauderdale 33308Completed
United States, Florida, Fort Pierce 34982Completed
United States, Florida, Orlando 32806Completed
United States, Florida, Orlando 32803Completed
United States, Florida, West Palm Beach 33401Completed
United States, Florida, Wilton Manor 33305Completed
United States, Georgia, Augusta 30912Completed
United States, Georgia, SAVANNAH 31401Completed
United States, Illinois, Chicago 60612Completed
United States, Illinois, Maywood 60153Completed
United States, Indiana, Indianapolis 46202Completed
United States, Iowa, Iowa City 52242Completed
United States, Massachusetts, Springfield 01105Completed
United States, Michigan, Detroit 48202Completed
United States, Michigan, Lansing 48911Completed
United States, Minnesota, Minneapolis 55404Completed
United States, Minnesota, Minneapolis 55415Completed
United States, Missouri, Kansas City 64106Completed
United States, Missouri, St. Louis 63108Completed
United States, Nebraska, Omaha 68106Completed
United States, New Jersey, Hillsborough 08844Completed
United States, New Jersey, Neptune 07753Completed
United States, New Jersey, Newark 07102Completed
United States, New Jersey, Newark 07103Completed
United States, New York, Bronx 10467Completed
United States, New York, New York 10003Completed
United States, New York, New York 10011Completed
United States, New York, Valhalla 10595Completed
United States, North Carolina, Chapel Hill 27514Completed
United States, North Carolina, Charlotte 28209Completed
United States, North Carolina, Charlotte 28207Completed
United States, North Carolina, Durham 27710Completed
United States, North Carolina, Greenville 27834Completed
United States, Ohio, Akron 44304Completed
United States, Ohio, Cincinnati 45267Completed
United States, Oregon, Portland 97210Completed
United States, Pennsylvania, Allentown 18102Completed
United States, Pennsylvania, Philadelphia 19104Completed
United States, Pennsylvania, Philadelphia 19140Completed
United States, Rhode Island, Providence 02906Completed
United States, Texas, Dallas 75246Completed
United States, Texas, Dallas 75204Completed
United States, Texas, Fort Worth 76104Completed
United States, Texas, Houston 77401Completed
United States, Texas, Houston 77004Completed
United States, Texas, Houston 77098Completed
United States, Texas, Longview 75605Completed
United States, Texas, San Antonio 78229Completed
United States, Utah, Salt Lake City 84132Completed
United States, Virginia, Annandale 22003Completed
United States, Washington, Seattle 98104Completed
United States, Washington, Spokane 99204Completed

Study Design

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: Yes
  • Masked Caregiver: Yes
  • Masked Investigator: Yes
  • Masked Assessor: Yes
Primary Outcomes:

  • Percentage of participants with HIV-1 RNA <50 copies/milliliter (c/mL) at Week 48
    Timeframe: Week 48

Secondary Outcomes:

  • Number of participants (par.) with detectable virus that has genotypic or phenotypic evidence of treatment-emergent INI resistance at time of protocol defined virology failure (PDVF)
    Timeframe: Baseline until PDVF up to Week 48

  • Number of participants with plasma HIV-1 RNA <50 c/mL at Week 24
    Timeframe: Week 24

  • Number of participants with plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48
    Timeframe: Week 24, Week 48

  • Absolute values and change from Baseline in cluster of differentiation 4+ (CD4+) cell counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48
    Timeframe: Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48

  • Number of participants with indicated post-Baseline HIV-associated conditions, excluding recurrences, and disease progressions
    Timeframe: From Baseline (Day 1) until Week 48

  • Number of participants with the indicated post-Baseline emergent Grade 1 to 4 clinical chemistry and hematology toxicities/laboratory adverse events (AEs)
    Timeframe: From Baseline 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

  • DTG PK parameters including Cmax, Cmin, C0, and C0_avg
    Timeframe: Week 4, Week 24, and Week 48

  • DTG PK parameters including AUC(0-tau)
    Timeframe: Week 4, Week 24, and Week 48

Arms:
  • 2

Interventions:

  • Drug: GSK1349572
  • Drug: Raltegravir
  • Drug: GSK1349572 Placebo
  • Drug: Raltegravir Placebo

Keyword:

  • ART-experienced, Integrase inhibitor, Raltegravir, GSK1349572, Integrase inhibitor naive
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 724

Clinical Publications:

  • Cahn P, Pozniak A, Mingrone H, et al. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. July 2013 epub ahead of print.