A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults
SAILING
A Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered With an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral-Experienced Adults
2 other identifiers
interventional
724
20 countries
180
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2010
Longer than P75 for phase_3
180 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2010
CompletedStudy Start
First participant enrolled
October 26, 2010
CompletedFirst Posted
Study publicly available on registry
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2013
CompletedResults Posted
Study results publicly available
January 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2021
CompletedMarch 15, 2022
March 1, 2022
2.3 years
October 21, 2010
August 15, 2013
March 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48
The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) \<50 c/mL at Week 48 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the randomized phase of the study.
At Week 48
Secondary Outcomes (13)
Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent Integrase Inhibitor (INI) Resistance at Time of Protocol Defined Virology Failure (PDVF)
Baseline (Day 1) until PDVF (Up to Week 48)
Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
At Week 24
Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48
At Week 24 and Week 48
Absolute Values of Cluster of Differentiation 4+ (CD4+) Cell Counts at Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12,16, 24, 32, 40, 48, 96 and 144
Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
- +8 more secondary outcomes
Other Outcomes (2)
Absolute Values of Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48
At Weeks 4, 8, 12, 16, 24, 32, 40, and 48
Change From Baseline in CD8+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48
Baseline (Day 1); Weeks 4, 8, 12, 16, 24, 32, 40, and 48
Study Arms (2)
GSK1349572 + Raltegravir Placebo
EXPERIMENTALSubjects will receive GSK1349572 50mg once daily plus raltegravir placebo twice daily.
Raltegravir + GSK1349572 Placebo
ACTIVE COMPARATORSubjects will receive raltegravir 400mg twice daily plus GSK1349572 placebo once daily.
Interventions
Eligibility Criteria
You may qualify if:
- Antiretroviral therapy (ART)-experienced, Human Immunodeficiency Virus (HIV) -1 infected adults at least 18 years of age.
- Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol).
- HIV-1 infection as documented by HIV-1 RNA \>400 copies/mL (c/mL) at Screening and with at least one consecutive HIV-1 RNA \>400 c/mL within the four months prior to Screening (unless the Screening HIV-1 RNA is \> 1000 c/mL where no additional plasma HIV-1 RNA assessment is needed).
- Have documented resistance (via Screening resistance test) to two or more different classes of antiretroviral agents. For subjects off ART for at least one month, if Screening resistance results provide a fully active agent and do not show two class resistance then historical resistance results from the subject's most recent resistance testing may be used, following consultation with the study virologist and /or medical monitor.
- Integrase inhibitor (INI)-naïve, defined as no prior exposure to any INI (e.g. RAL, elvitegravir, or GSK1349572).
- Able to provide written informed consent prior to Screening.
You may not qualify if:
- Screening resistance test result indicates no fully active antiviral agents are available for design of the background regimen.
- Subject-virus does not yield results using genotype/phenotype/tropism at Screening (assay data is essential for eligibility determination).
- Women who are breastfeeding.
- Any evidence of an active AIDS-defining condition (except cutaneous Kaposi's sarcoma not requiring systemic therapy or CD4+ \<200c/mm3).
- Subjects with moderate to severe hepatic impairment as defined by Child-Pugh classification.
- Recent history (less than or equal to 3 months) of upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding.
- Anticipated need for hepatitis C therapy during the study.
- History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days prior to Screening.
- Treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, any immunomodulator.
- Treatment with any agent, other than licensed ART, which has documented activity against HIV-1 in vitro within 28 days of first dose of investigational product.
- Exposure to an experimental drug and/or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the experimental test agent - whichever is longer, prior to the first dose of IP.
- French subjects recruited at sites in France will be excluded if the subject has participated in any study using an investigational drug and/or vaccine within 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine - whichever is longer - prior to screening for the study or the subject plans to participate simultaneously in another clinical study.
- Any acute or verified Grade 4 laboratory abnormality.
- Alanine aminotransferase (ALT) \>5 times the upper limit of normal (ULN).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- Shionogicollaborator
- GlaxoSmithKlinecollaborator
Study Sites (180)
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Phoenix, Arizona, 85012, United States
GSK Investigational Site
Little Rock, Arkansas, 72207, United States
GSK Investigational Site
Bakersfield, California, 93301, United States
GSK Investigational Site
Beverly Hills, California, 90211, United States
GSK Investigational Site
Long Beach, California, 90813, United States
GSK Investigational Site
Los Angeles, California, 90036, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Los Angeles, California, 90069, United States
GSK Investigational Site
Oakland, California, 94609, United States
GSK Investigational Site
New Haven, Connecticut, 06520, United States
GSK Investigational Site
Norwalk, Connecticut, 06850, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20007, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20009, United States
GSK Investigational Site
Daytona Beach, Florida, 32117, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Ft. Pierce, Florida, 34982, United States
GSK Investigational Site
Orlando, Florida, 32803, United States
GSK Investigational Site
Orlando, Florida, 32806, United States
GSK Investigational Site
West Palm Beach, Florida, 33401, United States
GSK Investigational Site
Wilton Manors, Florida, 33305, United States
GSK Investigational Site
Augusta, Georgia, 30912, United States
GSK Investigational Site
Savannah, Georgia, 31401, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Maywood, Illinois, 60153, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Iowa City, Iowa, 52242, United States
GSK Investigational Site
Springfield, Massachusetts, 01105, United States
GSK Investigational Site
Detroit, Michigan, 48202, United States
GSK Investigational Site
Lansing, Michigan, 48911, United States
GSK Investigational Site
Minneapolis, Minnesota, 55404, United States
GSK Investigational Site
Minneapolis, Minnesota, 55415, United States
GSK Investigational Site
Kansas City, Missouri, 64106, United States
GSK Investigational Site
St Louis, Missouri, 63108, United States
GSK Investigational Site
Omaha, Nebraska, 68106, United States
GSK Investigational Site
Hillsborough, New Jersey, 08844, United States
GSK Investigational Site
Neptune City, New Jersey, 07753, United States
GSK Investigational Site
Newark, New Jersey, 07102, United States
GSK Investigational Site
Newark, New Jersey, 07103, United States
GSK Investigational Site
New York, New York, 10003, United States
GSK Investigational Site
New York, New York, 10011, United States
GSK Investigational Site
The Bronx, New York, 10467, United States
GSK Investigational Site
Valhalla, New York, 10595, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27514, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Charlotte, North Carolina, 28209, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Greenville, North Carolina, 27834, United States
GSK Investigational Site
Akron, Ohio, 44304, United States
GSK Investigational Site
Cincinnati, Ohio, 45267, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Allentown, Pennsylvania, 18102, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19104, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
Providence, Rhode Island, 02906, United States
GSK Investigational Site
Dallas, Texas, 75204, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Houston, Texas, 77004, United States
GSK Investigational Site
Houston, Texas, 77098, United States
GSK Investigational Site
Houston, Texas, 77401, United States
GSK Investigational Site
Longview, Texas, 75605, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Salt Lake City, Utah, 84132, United States
GSK Investigational Site
Annandale, Virginia, 22003, United States
GSK Investigational Site
Seattle, Washington, 98104, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1264AAJ, Argentina
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1405CKC, Argentina
GSK Investigational Site
Ciudad de Buenos Aires, Buenos Aires, C1202ABB, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, 2000, Argentina
GSK Investigational Site
Buenos Aires, 1141, Argentina
GSK Investigational Site
Buenos Aires, C1181ACH, Argentina
GSK Investigational Site
Darlinghurst, New South Wales, 2010, Australia
GSK Investigational Site
Melbourne, Victoria, 3004, Australia
GSK Investigational Site
Antwerp, 2000, Belgium
GSK Investigational Site
Brussels, 1000, Belgium
GSK Investigational Site
Charleroi, 6000, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30130100, Brazil
GSK Investigational Site
Curitiba, Paraná, 80240-280, Brazil
GSK Investigational Site
São Paulo, São Paulo, 01246-090, Brazil
GSK Investigational Site
São Paulo, São Paulo, 04040-002, Brazil
GSK Investigational Site
Rio de Janeiro, 21040-360, Brazil
GSK Investigational Site
Salvador, 40110-060, Brazil
GSK Investigational Site
Santos, 11045-904, Brazil
GSK Investigational Site
São Paulo, 04121-000, Brazil
GSK Investigational Site
Vitória, 29041-091, Brazil
GSK Investigational Site
Vancouver, British Columbia, V6Z 2C7, Canada
GSK Investigational Site
Hamilton, Ontario, L8N3Z5, Canada
GSK Investigational Site
Toronto, Ontario, M4T 3A7, Canada
GSK Investigational Site
Toronto, Ontario, M5G 2N2, Canada
GSK Investigational Site
Montreal, Quebec, H2L 5B1, Canada
GSK Investigational Site
Montreal, Quebec, H2W 1T8, Canada
GSK Investigational Site
Puente Alto - Santiago, Región Metro de Santiago, 8207257, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 8320000, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 8330074, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 8900088, Chile
GSK Investigational Site
Santiago, 8360159, Chile
GSK Investigational Site
Bordeaux, 33000, France
GSK Investigational Site
Garches, 92380, France
GSK Investigational Site
Le Kremlin-Bicêtre, 94275, France
GSK Investigational Site
Marseille, 13009, France
GSK Investigational Site
Nice, 06202, France
GSK Investigational Site
Orléans, 45100, France
GSK Investigational Site
Paris, 75018, France
GSK Investigational Site
Paris, 75475, France
GSK Investigational Site
Paris, 75651, France
GSK Investigational Site
Paris, 75970, France
GSK Investigational Site
Tourcoing, 59208, France
GSK Investigational Site
Athens, 11527, Greece
GSK Investigational Site
Athens, 161 21, Greece
GSK Investigational Site
Piraeus, 18536, Greece
GSK Investigational Site
Rio, Patras, 26504, Greece
GSK Investigational Site
Budapest, 1097, Hungary
GSK Investigational Site
Modena, Emilia-Romagna, 41100, Italy
GSK Investigational Site
Busto Arsizio (VA), Lombardy, 21052, Italy
GSK Investigational Site
Milan, Lombardy, 20127, Italy
GSK Investigational Site
Monza, Lombardy, 20900, Italy
GSK Investigational Site
Turin, Piedmont, 10149, Italy
GSK Investigational Site
Cagliari, Sardinia, 09121, Italy
GSK Investigational Site
León, Guanajuato, Guanajuato, 37320, Mexico
GSK Investigational Site
Guadalajara, Jalisco, 44280, Mexico
GSK Investigational Site
Cuautitlán, Estado de México, State of Mexico, 54800, Mexico
GSK Investigational Site
Mexico City, 03720, Mexico
GSK Investigational Site
Amsterdam, 1105 AZ, Netherlands
GSK Investigational Site
Rotterdam, 3079 DZ, Netherlands
GSK Investigational Site
Chorzów, 41-500, Poland
GSK Investigational Site
Bucharest, 021105, Romania
GSK Investigational Site
Bucharest, 030303, Romania
GSK Investigational Site
Constanța, 900709, Romania
GSK Investigational Site
Kazan', 420097, Russia
GSK Investigational Site
Krasnodar, 350015, Russia
GSK Investigational Site
Moscow, 105275, Russia
GSK Investigational Site
Moscow, 129110, Russia
GSK Investigational Site
N.Novgorod, 603005, Russia
GSK Investigational Site
Perm, 614088, Russia
GSK Investigational Site
Ryazan, 390046, Russia
GSK Investigational Site
Saint Petersburg, 190103, Russia
GSK Investigational Site
Saratov, 410009, Russia
GSK Investigational Site
Toliyatti, 445846, Russia
GSK Investigational Site
Volgograd, 400040, Russia
GSK Investigational Site
Yekaterinburg, 620149, Russia
GSK Investigational Site
Bloemfontein, 9301, South Africa
GSK Investigational Site
Dundee, 3000, South Africa
GSK Investigational Site
Durban, 4001, South Africa
GSK Investigational Site
(Móstoles) Madrid, 28935, Spain
GSK Investigational Site
A Coruña, 15006, Spain
GSK Investigational Site
Alicante, 03010, Spain
GSK Investigational Site
Badalona, 08916, Spain
GSK Investigational Site
Barcelona, 08025, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Cartagena (Murcia), 30202, Spain
GSK Investigational Site
Elche (Alicante), 03202, Spain
GSK Investigational Site
Granada, 18003, Spain
GSK Investigational Site
Granada, 18014, Spain
GSK Investigational Site
Granollers (Barcelona), 08400, Spain
GSK Investigational Site
Madrid, 28006, Spain
GSK Investigational Site
Madrid, 28029, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Mataró, 08304, Spain
GSK Investigational Site
Murcia, 30003, Spain
GSK Investigational Site
Sabadell (Barcelona), 08208, Spain
GSK Investigational Site
San Sebastián, 20014, Spain
GSK Investigational Site
Seville, 41007, Spain
GSK Investigational Site
Seville, 41013, Spain
GSK Investigational Site
Valencia, 46010, Spain
GSK Investigational Site
Valencia, 46015, Spain
GSK Investigational Site
Kaohsiung City, 813, Taiwan
GSK Investigational Site
Kaohsiung City, 824, Taiwan
GSK Investigational Site
Taichung, 404, Taiwan
GSK Investigational Site
Taichung, 406, Taiwan
GSK Investigational Site
Taipei, 11217, Taiwan
GSK Investigational Site
Woolwich, London, London, SE18 4QH, United Kingdom
GSK Investigational Site
Crumpsall, Manchester, M8 5RB, United Kingdom
GSK Investigational Site
Liverpool, L7 8XP, United Kingdom
GSK Investigational Site
Tooting, London, SW17 0QT, United Kingdom
Related Publications (2)
Cahn P, Pozniak AL, Mingrone H, Shuldyakov A, Brites C, Andrade-Villanueva JF, Richmond G, Buendia CB, Fourie J, Ramgopal M, Hagins D, Felizarta F, Madruga J, Reuter T, Newman T, Small CB, Lombaard J, Grinsztejn B, Dorey D, Underwood M, Griffith S, Min S; extended SAILING Study Team. 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. 2013 Aug 24;382(9893):700-8. doi: 10.1016/S0140-6736(13)61221-0. Epub 2013 Jul 3.
PMID: 23830355BACKGROUNDBenlarbi M, Richard J, Clemente T, Bourassa C, Tolbert WD, Prakash M, Chandravanshi M, Clark A, Pazgier M, Durand M, Castagna A, Finzi A. Fostemsavir Decreases the Levels of Anti-gp120 CD4-Induced Antibodies in Heavily Treatment-Experienced People With HIV. J Infect Dis. 2025 Sep 24:jiaf461. doi: 10.1093/infdis/jiaf461. Online ahead of print.
PMID: 40990223DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- ViiV Healthcare
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
ViiV Healthcare
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2010
First Posted
November 1, 2010
Study Start
October 26, 2010
Primary Completion
February 4, 2013
Study Completion
February 2, 2021
Last Updated
March 15, 2022
Results First Posted
January 31, 2014
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.