A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults
NCT ID: NCT01231516
Last Updated: 2022-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
724 participants
INTERVENTIONAL
2010-10-26
2021-02-02
Brief Summary
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Detailed Description
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Subjects must have documented genotypic or phenotypic resistance to at least one member of each of at least two antiretroviral therapy (ART) drug classes \[nucleoside/nucleotide reverse transcriptase inhibitor (N\[t\]RTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI), fusion inhibitor (T20), or entry inhibitor (chemokine receptor 5 \[CCR5\] antagonist)\].
The primary analysis will take place after the last subject completes 48 weeks on therapy. An additional data cut and analysis will be conducted after the last subject completes 24 weeks on therapy.
Subjects randomized to GSK1349572 who successfully complete Week 48 will continue to received GSK1349572 until either it is locally available, until they no longer derive clinical benefit, until they meet a protocol-defined reason for discontinuation, or until development of the compound is terminated.
ViiV Healthcare is the sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GSK1349572 + Raltegravir Placebo
Subjects will receive GSK1349572 50mg once daily plus raltegravir placebo twice daily.
GSK1349572
50mg once daily
Raltegravir Placebo
Inactive placebo tablet twice daily
Raltegravir + GSK1349572 Placebo
Subjects will receive raltegravir 400mg twice daily plus GSK1349572 placebo once daily.
Raltegravir
400mg twice daily
GSK1349572 Placebo
Inactive placebo tablet once daily
Interventions
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GSK1349572
50mg once daily
Raltegravir
400mg twice daily
GSK1349572 Placebo
Inactive placebo tablet once daily
Raltegravir Placebo
Inactive placebo tablet twice daily
Eligibility Criteria
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Inclusion Criteria
* 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.
* French subjects: In France, subjects will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion Criteria
* 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.
* History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma; other localized malignancies require agreement between the investigator and study medical monitor for inclusion of the subject.
* 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).
* ALT greater than or equal to 3xULN and bilirubin greater than or equal to 1.5xULN (with \>35% direct bilirubin).
18 Years
ALL
No
Sponsors
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Shionogi
INDUSTRY
GlaxoSmithKline
INDUSTRY
ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
ViiV Healthcare
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
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Phoenix, Arizona, 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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Los Angeles, California, United States
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Oakland, California, United States
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New Haven, Connecticut, United States
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Norwalk, Connecticut, 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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Daytona Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Lauderdale, Florida, United States
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Ft. Pierce, Florida, United States
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Orlando, 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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Wilton Manors, Florida, United States
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Augusta, Georgia, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Maywood, Illinois, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Lansing, Michigan, United States
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Minneapolis, Minnesota, United States
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Minneapolis, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Hillsborough, New Jersey, United States
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Neptune City, New Jersey, United States
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Newark, New Jersey, 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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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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Greenville, North Carolina, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Providence, Rhode Island, 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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Houston, Texas, United States
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Houston, Texas, United States
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Longview, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Annandale, Virginia, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Darlinghurst, New South Wales, Australia
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Melbourne, Victoria, Australia
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Antwerp, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Liège, , Belgium
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Belo Horizonte, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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Santos, , Brazil
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São Paulo, , Brazil
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Vitória, , Brazil
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Vancouver, British Columbia, Canada
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Hamilton, Ontario, 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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Puente Alto - Santiago, Región Metro de Santiago, Chile
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Santiago, Región Metro de Santiago, Chile
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Santiago, Región Metro de Santiago, Chile
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Santiago, Región Metro de Santiago, Chile
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Santiago, , Chile
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Bordeaux, , France
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Garches, , France
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Le Kremlin-Bicêtre, , France
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Marseille, , France
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Nice, , France
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Orléans, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Tourcoing, , France
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Athens, , Greece
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Athens, , Greece
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Piraeus, , Greece
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Rio, Patras, , Greece
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Budapest, , Hungary
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Modena, Emilia-Romagna, Italy
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Busto Arsizio (VA), Lombardy, Italy
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Milan, Lombardy, Italy
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Monza, Lombardy, Italy
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Turin, Piedmont, Italy
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Cagliari, Sardinia, Italy
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León, Guanajuato, Guanajuato, Mexico
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Guadalajara, Jalisco, Mexico
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Cuautitlán, Estado de México, State of Mexico, Mexico
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Mexico City, , Mexico
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Amsterdam, , Netherlands
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Rotterdam, , Netherlands
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Chorzów, , Poland
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Bucharest, , Romania
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Bucharest, , Romania
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Constanța, , Romania
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Kazan', , Russia
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Krasnodar, , Russia
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Moscow, , Russia
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Moscow, , Russia
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N.Novgorod, , Russia
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Perm, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Toliyatti, , Russia
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Volgograd, , Russia
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Yekaterinburg, , Russia
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Bloemfontein, , South Africa
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Dundee, , South Africa
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Durban, , South Africa
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(Móstoles) Madrid, , Spain
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A Coruña, , 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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Cartagena (Murcia), , Spain
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Elche (Alicante), , Spain
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Granada, , Spain
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Granada, , Spain
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Granollers (Barcelona), , 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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Mataró, , Spain
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Murcia, , Spain
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Sabadell (Barcelona), , Spain
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San Sebastián, , Spain
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Seville, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Woolwich, London, London, United Kingdom
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Crumpsall, Manchester, , United Kingdom
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Liverpool, , United Kingdom
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Tooting, London, , United Kingdom
Countries
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References
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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.
Benlarbi 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.
Other Identifiers
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2009-018001-51
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
111762
Identifier Type: -
Identifier Source: org_study_id
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