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A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults (SAILING)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01231516
First received: October 21, 2010
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Infection, Human Immunodeficiency Virus
Drug: GSK1349572
Drug: Raltegravir
Drug: GSK1349572 Placebo
Drug: Raltegravir Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Percentage of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) [ Time Frame: Baseline until PDVF up to Week 48 ] [ Designated as safety issue: No ]
    For par. meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure and Baseline were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) virologic non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) virologic rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.

  • Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 24 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 24 as nonresponders, as well as participants who switched their concomitant ART prior to Week 24 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 measurement through Week 24 (within window) while the participant was on-treatment. The result below corresponds to the Week 24 interim analysis.

  • Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48 [ Time Frame: Week 24, Week 48 ] [ Designated as safety issue: No ]
    The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at the visit of interest 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 the visit of interest as nonresponders, as well as participants who switched their concomitant ART prior to the visit of interest 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 measurment (within window) for the timepoint of interest while the participant was on-treatment.

  • 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 [ Time Frame: Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    The absolute value for CD4+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline (BL), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40 and Week 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

  • Number of Participants With Indicated Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions [ Time Frame: From Baseline (Day 1) until Week 48 ] [ Designated as safety issue: No ]
    Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.

  • Number of Participants With the Indicated Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. .

  • DTG PK Parameters Including Cmax, Cmin, C0, and C0_avg [ Time Frame: Week 4, Week 24, and Week 48 ] [ Designated as safety issue: No ]
    The maximal concentration (Cmax), and the minimal concentration (Cmin) were assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. DTG predose concentration (C0) at Week 4, Week 24, and Week 48 as well as the average C0 (C0_avg) , Cmax and Cmin were estimated and reported here.

  • DTG PK Parameters Including AUC(0-tau) [ Time Frame: Week 4, Week 24, and Week 48 ] [ Designated as safety issue: No ]
    AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. AUC was assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48.


Other Outcome Measures:
  • Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48 [ Time Frame: Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48 ] [ Designated as safety issue: No ]
    The absolute value data for CD8+ cell count (cells per millimeters cubed [mm^3]) were only reported on a per-participant basis and were not summarized.


Enrollment: 724
Study Start Date: October 2010
Estimated Study Completion Date: November 2015
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK1349572 + Raltegravir Placebo
Subjects will receive GSK1349572 50mg once daily plus raltegravir placebo twice daily.
Drug: GSK1349572
50mg once daily
Drug: Raltegravir Placebo
Inactive placebo tablet twice daily
Active Comparator: Raltegravir + GSK1349572 Placebo
Subjects will receive raltegravir 400mg twice daily plus GSK1349572 placebo once daily.
Drug: Raltegravir
400mg twice daily
Drug: GSK1349572 Placebo
Inactive placebo tablet once daily

Detailed 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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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:

  • 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.
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231516

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85012
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72207
United States, California
GSK Investigational Site
Bakersfield, California, United States, 93301
GSK Investigational Site
Beverly Hills, California, United States, 90211
GSK Investigational Site
Long Beach, California, United States, 90813
GSK Investigational Site
Los Angeles, California, United States, 90048
GSK Investigational Site
Los Angeles, California, United States, 90015
GSK Investigational Site
Los Angeles, California, United States, 90069
GSK Investigational Site
Los Angeles, California, United States, 90036
GSK Investigational Site
Oakland, California, United States, 94609
United States, Connecticut
GSK Investigational Site
New Haven, Connecticut, United States, 06520
GSK Investigational Site
Norwalk, Connecticut, United States, 06850
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20007
GSK Investigational Site
Washington, District of Columbia, United States, 20009
United States, Florida
GSK Investigational Site
Daytona Beach, Florida, United States, 32117
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Fort Pierce, Florida, United States, 34982
GSK Investigational Site
Miami Beach, Florida, United States, 33139
GSK Investigational Site
Orlando, Florida, United States, 32806
GSK Investigational Site
Orlando, Florida, United States, 32803
GSK Investigational Site
West Palm Beach, Florida, United States, 33401
GSK Investigational Site
Wilton Manor, Florida, United States, 33305
United States, Georgia
GSK Investigational Site
Augusta, Georgia, United States, 30912
GSK Investigational Site
Savannah, Georgia, United States, 31401
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Chicago, Illinois, United States, 60611
GSK Investigational Site
Maywood, Illinois, United States, 60153
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Iowa
GSK Investigational Site
Iowa City, Iowa, United States, 52242
United States, Massachusetts
GSK Investigational Site
Springfield, Massachusetts, United States, 01105
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48202
GSK Investigational Site
Lansing, Michigan, United States, 48911
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
GSK Investigational Site
Minneapolis, Minnesota, United States, 55415
United States, Missouri
GSK Investigational Site
Kansas City, Missouri, United States, 64111
GSK Investigational Site
Kansas City, Missouri, United States, 64106
GSK Investigational Site
St. Louis, Missouri, United States, 63108
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68106
United States, New Jersey
GSK Investigational Site
Hillsborough, New Jersey, United States, 08844
GSK Investigational Site
Neptune, New Jersey, United States, 07753
GSK Investigational Site
Newark, New Jersey, United States, 07103
GSK Investigational Site
Newark, New Jersey, United States, 07102
United States, New York
GSK Investigational Site
Bronx, New York, United States, 10467
GSK Investigational Site
New York, New York, United States, 10011
GSK Investigational Site
New York, New York, United States, 10003
GSK Investigational Site
Valhalla, New York, United States, 10595
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27514
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Durham, North Carolina, United States, 27710
GSK Investigational Site
Greenville, North Carolina, United States, 27834
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44304
GSK Investigational Site
Cincinnati, Ohio, United States, 45267
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
GSK Investigational Site
Tulsa, Oklahoma, United States, 74107
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Investigational Site
Allentown, Pennsylvania, United States, 18102
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
GSK Investigational Site
Providence, Rhode Island, United States, 02906
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29425
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Dallas, Texas, United States, 75204
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Houston, Texas, United States, 77098
GSK Investigational Site
Houston, Texas, United States, 77401
GSK Investigational Site
Houston, Texas, United States, 77004
GSK Investigational Site
Longview, Texas, United States, 75605
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Virginia
GSK Investigational Site
Annandale, Virginia, United States, 22003
GSK Investigational Site
Springfield, Virginia, United States, 22151
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98104
GSK Investigational Site
Spokane, Washington, United States, 99204
Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1264AAJ
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1405CKC
GSK Investigational Site
Rosario, Santa Fe, Argentina, 2000
GSK Investigational Site
Buenos Aires, Argentina, 1141
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH
GSK Investigational Site
Ciudad de Buenos Aires, Argentina, C1202ABB
Australia, New South Wales
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Australia, Victoria
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
Belgium
GSK Investigational Site
Antwerpen, Belgium, 2000
GSK Investigational Site
Brussels, Belgium, 1000
GSK Investigational Site
Charleroi, Belgium, 6000
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Liege, Belgium, 4000
Brazil
GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30130100
GSK Investigational Site
Curitiba, Paraná, Brazil, 80240-280
GSK Investigational Site
Sao Paulo, São Paulo, Brazil, 01246-090
GSK Investigational Site
Sao Paulo, São Paulo, Brazil, 04040-002
GSK Investigational Site
Rio de Janeiro, Brazil, 21040-360
GSK Investigational Site
Salvador, Brazil, 40110-060
GSK Investigational Site
Santos, Brazil, 11045-904
GSK Investigational Site
São Paulo, Brazil, 04121-000
GSK Investigational Site
Vitoria, Brazil, 29041-091
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y6
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2N2
GSK Investigational Site
Toronto, Ontario, Canada, M5B 1L6
GSK Investigational Site
Toronto, Ontario, Canada, M4T 3A7
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H3G 1A4
GSK Investigational Site
Montreal, Quebec, Canada, H2L 5B1
GSK Investigational Site
Montreal, Quebec, Canada, H2W 1T8
Chile
GSK Investigational Site
Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 8330074
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
GSK Investigational Site
Santiago, Chile, 8360159
France
GSK Investigational Site
Bordeaux, France, 33000
GSK Investigational Site
Garches, France, 92380
GSK Investigational Site
Le Kremlin Bicêtre cedex, France, 94275
GSK Investigational Site
Le Kremlin-Bicêtre Cedex, France, 94275
GSK Investigational Site
Lyon Cedex 03, France, 69437
GSK Investigational Site
Marseille, France, 13009
GSK Investigational Site
Nice, France, 06202
GSK Investigational Site
Orléans, France, 45100
GSK Investigational Site
Paris, France, 75018
GSK Investigational Site
Paris Cedex 10, France, 75475
GSK Investigational Site
Paris Cedex 13, France, 75651
GSK Investigational Site
Paris Cedex 20, France, 75970
GSK Investigational Site
Paris Cedex 4, France, 75181
GSK Investigational Site
Strasbourg cedex, France, 67091
GSK Investigational Site
Tourcoing cedex, France, 59208
Greece
GSK Investigational Site
Athens, Greece, 11527
GSK Investigational Site
Athens, Greece, 161 21
GSK Investigational Site
Piraeus, Greece, 18536
GSK Investigational Site
Rio, Patras, Greece, 26504
GSK Investigational Site
Thessaloniki, Greece, 54636
Hungary
GSK Investigational Site
Budapest, Hungary, 1097
Italy
GSK Investigational Site
Modena, Emilia-Romagna, Italy, 41100
GSK Investigational Site
Parma, Emilia-Romagna, Italy, 43100
GSK Investigational Site
Roma, Lazio, Italy, 00185
GSK Investigational Site
Busto Arsizio (VA), Lombardia, Italy, 21052
GSK Investigational Site
Milano, Lombardia, Italy, 20157
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Monza, Lombardia, Italy, 20900
GSK Investigational Site
Torino, Piemonte, Italy, 10149
GSK Investigational Site
Cagliari, Sardegna, Italy, 09121
Mexico
GSK Investigational Site
Cuautitlán, Estado de México, Estado de México, Mexico, 54800
GSK Investigational Site
León, Guanajuato, Guanajuato, Mexico, 37320
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44280
GSK Investigational Site
Distrito Federal, Mexico, 06470
GSK Investigational Site
Mexico City, Mexico, 03720
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
Arnhem, Netherlands, 6815 AD
GSK Investigational Site
Rotterdam, Netherlands, 3079 DZ
Poland
GSK Investigational Site
Chorzow, Poland, 41-500
Romania
GSK Investigational Site
Bucharest, Romania, 021105
GSK Investigational Site
Bucharest, Romania, 030317
GSK Investigational Site
Constanta, Romania, 900709
Russian Federation
GSK Investigational Site
Ekaterinburg, Russian Federation, 620149
GSK Investigational Site
Kazan, Russian Federation, 420097
GSK Investigational Site
Krasnodar, Russian Federation, 350015
GSK Investigational Site
Moscow, Russian Federation, 129110
GSK Investigational Site
Moscow, Russian Federation, 105275
GSK Investigational Site
N.Novgorod, Russian Federation, 603005
GSK Investigational Site
Perm, Russian Federation, 614088
GSK Investigational Site
Ryazan, Russian Federation, 390046
GSK Investigational Site
Saratov, Russian Federation, 410009
GSK Investigational Site
St. Petersburg, Russian Federation, 190103
GSK Investigational Site
Toliyatti, Russian Federation, 445846
GSK Investigational Site
Volgograd, Russian Federation, 400040
South Africa
GSK Investigational Site
Bloemfontein, South Africa, 9301
GSK Investigational Site
Dundee, South Africa, 3000
GSK Investigational Site
Durban, South Africa, 4001
Spain
GSK Investigational Site
(Móstoles) Madrid, Spain, 28935
GSK Investigational Site
Alcala de Henares, Spain, 28805
GSK Investigational Site
Alicante, Spain, 03010
GSK Investigational Site
Badalona, Spain, 08916
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Cartagena (Murcia), Spain, 30202
GSK Investigational Site
Elche (Alicante), Spain, 03202
GSK Investigational Site
Granada, Spain, 18014
GSK Investigational Site
Granada, Spain, 18003
GSK Investigational Site
Granollers (Barcelona), Spain, 08400
GSK Investigational Site
La Coruña, Spain, 15006
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Madrid, Spain, 28006
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Madrid, Spain, 28029
GSK Investigational Site
Mataró, Spain, 08304
GSK Investigational Site
Murcia, Spain
GSK Investigational Site
Oviedo, Spain, 33006
GSK Investigational Site
Sabadell (Barcelona), Spain, 08208
GSK Investigational Site
San Sebastián, Spain, 20014
GSK Investigational Site
Sevilla, Spain, 41013
GSK Investigational Site
Sevilla, Spain, 41007
GSK Investigational Site
Valencia, Spain, 46010
GSK Investigational Site
Valencia, Spain, 46015
Taiwan
GSK Investigational Site
Kaohsiung, Taiwan, 824
GSK Investigational Site
Kaohsiung, Taiwan, 813
GSK Investigational Site
Taichung, Taiwan, 404
GSK Investigational Site
Taichung, Taiwan, 406
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 11217
United Kingdom
GSK Investigational Site
Woolwich, London, London, United Kingdom, SE18 4QH
GSK Investigational Site
Birmingham, Warwickshire, United Kingdom, B29 6JD
GSK Investigational Site
Crumpsall, Manchester, United Kingdom, M8 5RB
GSK Investigational Site
Liverpool, United Kingdom, L7 8XP
GSK Investigational Site
London, United Kingdom, E1 1BB
GSK Investigational Site
London, United Kingdom, NW3 2QG
GSK Investigational Site
London, United Kingdom, SW1 7EH
GSK Investigational Site
Tooting, London, United Kingdom, SW17 0QT
Sponsors and Collaborators
ViiV Healthcare
Shionogi
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

No publications provided by ViiV Healthcare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01231516     History of Changes
Other Study ID Numbers: 111762
Study First Received: October 21, 2010
Results First Received: August 15, 2013
Last Updated: March 20, 2014
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios
Argentina: Ministry of Health - A.N.M.A.T
Italy: Comitato Etico Fondazione Centro San Raffaele del Monte Tabor - Via Olgettina, 60 - 20132 Milano
Brazil: National Health Surveillance Agency
Chile:Ministerio de Salud de Chile
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Belgium: Federal Agency for Medicines and Health Products, FAMHP
United States: Food and Drug Administration
Taiwan: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hungary: Országos Gyógyszerészeti Intézet
South Africa: Medicines Control Council
Romania: National Medicines Agency
Russia: Roszdrav Nadzor
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Canada: Health Canada
Mexico: COFEPRIS
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Australia: Therapeutic Goods Administration
Greece: National Drug Organisation

Keywords provided by ViiV Healthcare:
ART-experienced
Integrase inhibitor
Raltegravir
GSK1349572
Integrase inhibitor naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Dolutegravir
Integrase Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Integrase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014