Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01231516
Registration number
NCT01231516
Ethics application status
Date submitted
21/10/2010
Date registered
1/11/2010
Titles & IDs
Public title
A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2009-018001-51
Query!
Secondary ID [2]
0
0
111762
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SAILING
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Infection, Human Immunodeficiency Virus
0
0
Query!
HIV Infections
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Studies of infection and infectious agents
Query!
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Infection
0
0
0
0
Query!
Sexually transmitted infections
Query!
Infection
0
0
0
0
Query!
Acquired immune deficiency syndrome (AIDS / HIV)
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - GSK1349572
Treatment: Drugs - Raltegravir
Treatment: Drugs - GSK1349572 Placebo
Treatment: Drugs - Raltegravir Placebo
Experimental: GSK1349572 + Raltegravir Placebo - Subjects will receive GSK1349572 50mg once daily plus raltegravir placebo twice daily.
Active comparator: Raltegravir + GSK1349572 Placebo - Subjects will receive raltegravir 400mg twice daily plus GSK1349572 placebo once daily.
Treatment: Drugs: GSK1349572
50mg once daily
Treatment: Drugs: Raltegravir
400mg twice daily
Treatment: Drugs: GSK1349572 Placebo
Inactive placebo tablet once daily
Treatment: Drugs: Raltegravir Placebo
Inactive placebo tablet twice daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
At Week 48
Query!
Secondary outcome [1]
0
0
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)
Query!
Assessment method [1]
0
0
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 logarithm to base 10 (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.
Query!
Timepoint [1]
0
0
Baseline (Day 1) until PDVF (Up to Week 48)
Query!
Secondary outcome [2]
0
0
Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
At Week 24
Query!
Secondary outcome [3]
0
0
Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
At Week 24 and Week 48
Query!
Secondary outcome [4]
0
0
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
Query!
Assessment method [4]
0
0
Blood samples were collected at specified time points to assess CD4+ using flow cytometry. Median and interquartile range are presented. Baseline was the latest pre-dose assessment value (Day 1).
Query!
Timepoint [4]
0
0
Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
Query!
Secondary outcome [5]
0
0
Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12,16, 24, 32, 40, 48, 96 and 144
Query!
Assessment method [5]
0
0
Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline was the latest pre-dose assessment value (Day 1). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Median and interquartile range is presented.
Query!
Timepoint [5]
0
0
Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
Query!
Secondary outcome [6]
0
0
Number of Participants With Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions
Query!
Assessment method [6]
0
0
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 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 clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C:Clinical CON listed in acquired immunodeficiency syndrome (AIDS) surveillance case definition. Indicators of CDP defined as:CDC CAT A at Baseline (BS) to CDC CAT C event (EV); CDC CAT B at BS to CDC CAT C EV; CDC CAT C at BS to new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.
Query!
Timepoint [6]
0
0
Up to Week 480
Query!
Secondary outcome [7]
0
0
Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities
Query!
Assessment method [7]
0
0
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. Higher the grade, more severe the symptoms.
Query!
Timepoint [7]
0
0
From Baseline (Day 1) 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
Query!
Secondary outcome [8]
0
0
Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities
Query!
Assessment method [8]
0
0
Blood samples were collected for the analysis of clinical chemistry and hematology parameters: Alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hypoonatremia, LDL cholesterol, lipase, total bilirubin, triglycerides, hemoglibin, neutrophils, platelets, white blood cells. Any abnormality in clinical chemistry and hematology parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).Higher the grade, more severe the symptoms.
Query!
Timepoint [8]
0
0
From Week 48 to Week 480
Query!
Secondary outcome [9]
0
0
DTG PK Parameters Including Maximum Plasma Drug Concentration (Cmax), Minimal Plasma Drug Concentration (Cmin), and Average Plasma Pre-dose Concentration (C0_avg)
Query!
Assessment method [9]
0
0
Cmax, Cmin and C0_avg 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. Cmax, Cmin and C0_avg were estimated and reported here.
Query!
Timepoint [9]
0
0
Pre-dose and at 1 to 3 hours or 4 to 12 hours post-dose at Week 4; Pre-dose at Week 24; Pre-dose and 1 to 3 hours or 4 to 12 hours post-dose at Week 48
Query!
Secondary outcome [10]
0
0
DTG PK Parameter Including Pre-dose Concentration (C0)
Query!
Assessment method [10]
0
0
C0 was assessed by population 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 was estimated and reported here.
Query!
Timepoint [10]
0
0
Pre-dose at Weeks 4, 24 and 48
Query!
Secondary outcome [11]
0
0
DTG PK Parameters Including Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau Over a Dosing Interval at Steady State (AUC[0-tau])
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Pre-dose and at 1 to 3 hours or 4 to 12 hours post-dose at Week 4; Pre-dose at Week 24; Pre-dose and 1 to 3 hours or 4 to 12 hours post-dose at Week 48
Query!
Secondary outcome [12]
0
0
Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Utility Score
Query!
Assessment method [12]
0
0
The EQ-5D-3L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 3 levels for each dimension including 1=no problems, 2=some problems, 3=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-3L utility score ranges from -0.594 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value.
Query!
Timepoint [12]
0
0
Baseline (Day 1) and at Weeks 24 and 48
Query!
Secondary outcome [13]
0
0
Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Thermometer Scores
Query!
Assessment method [13]
0
0
The EQ-5D-3L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 3 levels for each dimension including 1=no problems, 2=some problems, 3=extreme problems. EQ-5D-3L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Participants were asked to rate their current health status using the visual analogue scale 'Thermometer'. Score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate better heath. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value.
Query!
Timepoint [13]
0
0
Baseline (Day 1) and at Weeks 24 and 48
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
26/10/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
2/02/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
724
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Darlinghurst
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
3004 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
District of Columbia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Iowa
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Minnesota
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nebraska
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New York
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Ohio
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oregon
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Pennsylvania
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Rhode Island
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Texas
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Utah
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Virginia
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Washington
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Buenos Aires
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Santa Fe
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Ciudad Autonoma de Buenos Aires
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Antwerpen
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Brussels
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Charleroi
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Liege
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Minas Gerais
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Paraná
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
São Paulo
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Rio de Janeiro
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
Salvador
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
Santos
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Vitoria
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
British Columbia
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Ontario
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Quebec
Query!
Country [45]
0
0
Chile
Query!
State/province [45]
0
0
Región Metro De Santiago
Query!
Country [46]
0
0
Chile
Query!
State/province [46]
0
0
Santiago
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Bordeaux
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Garches
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Le Kremlin Bicêtre cedex
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Le Kremlin-Bicêtre Cedex
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Marseille
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Nice
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Orléans
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Paris Cedex 10
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Paris Cedex 13
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Paris Cedex 20
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Paris
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Tourcoing cedex
Query!
Country [59]
0
0
Greece
Query!
State/province [59]
0
0
Athens
Query!
Country [60]
0
0
Greece
Query!
State/province [60]
0
0
Piraeus
Query!
Country [61]
0
0
Greece
Query!
State/province [61]
0
0
Rio, Patras
Query!
Country [62]
0
0
Hungary
Query!
State/province [62]
0
0
Budapest
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Emilia-Romagna
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Lombardia
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Piemonte
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Sardegna
Query!
Country [67]
0
0
Mexico
Query!
State/province [67]
0
0
Estado De México
Query!
Country [68]
0
0
Mexico
Query!
State/province [68]
0
0
Guanajuato
Query!
Country [69]
0
0
Mexico
Query!
State/province [69]
0
0
Jalisco
Query!
Country [70]
0
0
Mexico
Query!
State/province [70]
0
0
Mexico City
Query!
Country [71]
0
0
Netherlands
Query!
State/province [71]
0
0
Amsterdam
Query!
Country [72]
0
0
Netherlands
Query!
State/province [72]
0
0
Rotterdam
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Chorzow
Query!
Country [74]
0
0
Romania
Query!
State/province [74]
0
0
Bucharest
Query!
Country [75]
0
0
Romania
Query!
State/province [75]
0
0
Constanta
Query!
Country [76]
0
0
Russian Federation
Query!
State/province [76]
0
0
Ekaterinburg
Query!
Country [77]
0
0
Russian Federation
Query!
State/province [77]
0
0
Kazan
Query!
Country [78]
0
0
Russian Federation
Query!
State/province [78]
0
0
Krasnodar
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
Moscow
Query!
Country [80]
0
0
Russian Federation
Query!
State/province [80]
0
0
N.Novgorod
Query!
Country [81]
0
0
Russian Federation
Query!
State/province [81]
0
0
Perm
Query!
Country [82]
0
0
Russian Federation
Query!
State/province [82]
0
0
Ryazan
Query!
Country [83]
0
0
Russian Federation
Query!
State/province [83]
0
0
Saint-Petersburg
Query!
Country [84]
0
0
Russian Federation
Query!
State/province [84]
0
0
Saratov
Query!
Country [85]
0
0
Russian Federation
Query!
State/province [85]
0
0
Toliyatti
Query!
Country [86]
0
0
Russian Federation
Query!
State/province [86]
0
0
Volgograd
Query!
Country [87]
0
0
South Africa
Query!
State/province [87]
0
0
Bloemfontein
Query!
Country [88]
0
0
South Africa
Query!
State/province [88]
0
0
Dundee
Query!
Country [89]
0
0
South Africa
Query!
State/province [89]
0
0
Durban
Query!
Country [90]
0
0
Spain
Query!
State/province [90]
0
0
(Móstoles) Madrid
Query!
Country [91]
0
0
Spain
Query!
State/province [91]
0
0
Alicante
Query!
Country [92]
0
0
Spain
Query!
State/province [92]
0
0
Badalona
Query!
Country [93]
0
0
Spain
Query!
State/province [93]
0
0
Barcelona
Query!
Country [94]
0
0
Spain
Query!
State/province [94]
0
0
Cartagena (Murcia)
Query!
Country [95]
0
0
Spain
Query!
State/province [95]
0
0
Elche (Alicante)
Query!
Country [96]
0
0
Spain
Query!
State/province [96]
0
0
Granada
Query!
Country [97]
0
0
Spain
Query!
State/province [97]
0
0
Granollers (Barcelona)
Query!
Country [98]
0
0
Spain
Query!
State/province [98]
0
0
La Coruña
Query!
Country [99]
0
0
Spain
Query!
State/province [99]
0
0
Madrid
Query!
Country [100]
0
0
Spain
Query!
State/province [100]
0
0
Mataró
Query!
Country [101]
0
0
Spain
Query!
State/province [101]
0
0
Murcia
Query!
Country [102]
0
0
Spain
Query!
State/province [102]
0
0
Sabadell (Barcelona)
Query!
Country [103]
0
0
Spain
Query!
State/province [103]
0
0
San Sebastián
Query!
Country [104]
0
0
Spain
Query!
State/province [104]
0
0
Sevilla
Query!
Country [105]
0
0
Spain
Query!
State/province [105]
0
0
Valencia
Query!
Country [106]
0
0
Taiwan
Query!
State/province [106]
0
0
Kaohsiung
Query!
Country [107]
0
0
Taiwan
Query!
State/province [107]
0
0
Taichung
Query!
Country [108]
0
0
Taiwan
Query!
State/province [108]
0
0
Taipei
Query!
Country [109]
0
0
United Kingdom
Query!
State/province [109]
0
0
London
Query!
Country [110]
0
0
United Kingdom
Query!
State/province [110]
0
0
Crumpsall, Manchester
Query!
Country [111]
0
0
United Kingdom
Query!
State/province [111]
0
0
Liverpool
Query!
Country [112]
0
0
United Kingdom
Query!
State/province [112]
0
0
Tooting, London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
ViiV Healthcare
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Shionogi
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/industry
Query!
Name [2]
0
0
GlaxoSmithKline
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01231516
Query!
Trial related presentations / publications
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. Erratum In: Lancet. 2014 Jan 4;383(9911):30.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
ViiV Healthcare
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
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.
Query!
Available to whom?
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01231516