Back to results

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

Primary Purpose

Infection, Human Immunodeficiency Virus, HIV Infections

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

GSK1349572

Raltegravir

GSK1349572 Placebo

Raltegravir Placebo

About this trial

This is an interventional treatment trial for Infection, Human Immunodeficiency Virus focused on measuring ART-experienced, Integrase inhibitor, Raltegravir, GSK1349572, Integrase inhibitor naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GSK1349572 + Raltegravir Placebo

Raltegravir + GSK1349572 Placebo

Arm Description

Subjects will receive GSK1349572 50mg once daily plus raltegravir placebo twice daily.

Subjects will receive raltegravir 400mg twice daily plus GSK1349572 placebo once daily.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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.

Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24

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

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 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

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).

Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12,16, 24, 32, 40, 48, 96 and 144

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.

Number of Participants With Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions

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.

Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities

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.

Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities

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.

DTG PK Parameters Including Maximum Plasma Drug Concentration (Cmax), Minimal Plasma Drug Concentration (Cmin), and Average Plasma Pre-dose Concentration (C0_avg)

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.

DTG PK Parameter Including Pre-dose Concentration (C0)

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.

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])

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.

Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Utility Score

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.

Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Thermometer Scores

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.

Full Information

NCT ID

NCT01231516

First Posted

October 21, 2010

Last Updated

March 14, 2022

Sponsor

ViiV Healthcare

Collaborators

Shionogi, GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01231516

Brief Title

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

Acronym

SAILING

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

October 26, 2010 (Actual)

Primary Completion Date

February 4, 2013 (Actual)

Study Completion Date

February 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ViiV Healthcare

Collaborators

Shionogi, GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection, Human Immunodeficiency Virus, HIV Infections

Keywords

ART-experienced, Integrase inhibitor, Raltegravir, GSK1349572, Integrase inhibitor naive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

724 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK1349572 + Raltegravir Placebo

Arm Type

Experimental

Arm Description

Subjects will receive GSK1349572 50mg once daily plus raltegravir placebo twice daily.

Arm Title

Raltegravir + GSK1349572 Placebo

Arm Type

Active Comparator

Arm Description

Subjects will receive raltegravir 400mg twice daily plus GSK1349572 placebo once daily.

Intervention Type

Drug

Intervention Name(s)

GSK1349572

Intervention Description

50mg once daily

Intervention Type

Drug

Intervention Name(s)

Raltegravir

Intervention Description

400mg twice daily

Intervention Type

Drug

Intervention Name(s)

GSK1349572 Placebo

Intervention Description

Inactive placebo tablet once daily

Intervention Type

Drug

Intervention Name(s)

Raltegravir Placebo

Intervention Description

Inactive placebo tablet twice daily

Primary Outcome Measure Information:

Title

Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48

Description

Time Frame

At Week 48

Secondary Outcome Measure Information:

Title

Description

Time Frame

Baseline (Day 1) until PDVF (Up to Week 48)

Title

Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24

Description

Time Frame

At Week 24

Title

Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48

Description

Time Frame

At Week 24 and Week 48

Title

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

Description

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).

Time Frame

Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144

Title

Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12,16, 24, 32, 40, 48, 96 and 144

Description

Time Frame

Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144

Title

Number of Participants With Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions

Description

Time Frame

Up to Week 480

Title

Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities

Description

Time Frame

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

Title

Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities

Description

Time Frame

From Week 48 to Week 480

Title

DTG PK Parameters Including Maximum Plasma Drug Concentration (Cmax), Minimal Plasma Drug Concentration (Cmin), and Average Plasma Pre-dose Concentration (C0_avg)

Description

Time Frame

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

Title

DTG PK Parameter Including Pre-dose Concentration (C0)

Description

Time Frame

Pre-dose at Weeks 4, 24 and 48

Title

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])

Description

Time Frame

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

Title

Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Utility Score

Description

Time Frame

Baseline (Day 1) and at Weeks 24 and 48

Title

Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Thermometer Scores

Description

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.

Time Frame

Baseline (Day 1) and at Weeks 24 and 48

Other Pre-specified Outcome Measures:

Title

Absolute Values of Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48

Description

The absolute value data for CD8+ cell count was planned to be evaluated. The results for this outcome measure will never be posted.

Time Frame

At Weeks 4, 8, 12, 16, 24, 32, 40, and 48

Title

Change From Baseline in CD8+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48

Description

Change from Baseline data for CD8+ cell count was planned to be evaluated. The results for this outcome measure will never be posted.

Time Frame

Baseline (Day 1); Weeks 4, 8, 12, 16, 24, 32, 40, and 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

ViiV Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85012

Country

United States

Facility Name

GSK Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72207

Country

United States

Facility Name

GSK Investigational Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

GSK Investigational Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

GSK Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90069

Country

United States

Facility Name

GSK Investigational Site

City

Oakland

State/Province

California

ZIP/Postal Code

94609

Country

United States

Facility Name

GSK Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

GSK Investigational Site

City

Norwalk

State/Province

Connecticut

ZIP/Postal Code

06850

Country

United States

Facility Name

GSK Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

GSK Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20009

Country

United States

Facility Name

GSK Investigational Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

GSK Investigational Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

GSK Investigational Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33316

Country

United States

Facility Name

GSK Investigational Site

City

Fort Pierce

State/Province

Florida

ZIP/Postal Code

34982

Country

United States

Facility Name

GSK Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

GSK Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

GSK Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

GSK Investigational Site

City

Wilton Manors

State/Province

Florida

ZIP/Postal Code

33305

Country

United States

Facility Name

GSK Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

GSK Investigational Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31401

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

GSK Investigational Site

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

GSK Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

GSK Investigational Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

GSK Investigational Site

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01105

Country

United States

Facility Name

GSK Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

GSK Investigational Site

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48911

Country

United States

Facility Name

GSK Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

GSK Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55415

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64106

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63108

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68106

Country

United States

Facility Name

GSK Investigational Site

City

Hillsborough

State/Province

New Jersey

ZIP/Postal Code

08844

Country

United States

Facility Name

GSK Investigational Site

City

Neptune

State/Province

New Jersey

ZIP/Postal Code

07753

Country

United States

Facility Name

GSK Investigational Site

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07102

Country

United States

Facility Name

GSK Investigational Site

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07103

Country

United States

Facility Name

GSK Investigational Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10011

Country

United States

Facility Name

GSK Investigational Site

City

Valhalla

State/Province

New York

ZIP/Postal Code

10595

Country

United States

Facility Name

GSK Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

GSK Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

GSK Investigational Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

GSK Investigational Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44304

Country

United States

Facility Name

GSK Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

GSK Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

GSK Investigational Site

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18102

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

GSK Investigational Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75204

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

GSK Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77098

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

GSK Investigational Site

City

Longview

State/Province

Texas

ZIP/Postal Code

75605

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

GSK Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

GSK Investigational Site

City

Annandale

State/Province

Virginia

ZIP/Postal Code

22003

Country

United States

Facility Name

GSK Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

GSK Investigational Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1264AAJ

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autónoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1405CKC

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1202ABB

Country

Argentina

Facility Name

GSK Investigational Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

1141

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

GSK Investigational Site

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

GSK Investigational Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

GSK Investigational Site

City

Antwerpen

ZIP/Postal Code

2000

Country

Belgium

Facility Name

GSK Investigational Site

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

GSK Investigational Site

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

GSK Investigational Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

GSK Investigational Site

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30130100

Country

Brazil

Facility Name

GSK Investigational Site

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

80240-280

Country

Brazil

Facility Name

GSK Investigational Site

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

01246-090

Country

Brazil

Facility Name

GSK Investigational Site

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

04040-002

Country

Brazil

Facility Name

GSK Investigational Site

City

Rio de Janeiro

ZIP/Postal Code

21040-360

Country

Brazil

Facility Name

GSK Investigational Site

City

Salvador

ZIP/Postal Code

40110-060

Country

Brazil

Facility Name

GSK Investigational Site

City

Santos

ZIP/Postal Code

11045-904

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04121-000

Country

Brazil

Facility Name

GSK Investigational Site

City

Vitoria

ZIP/Postal Code

29041-091

Country

Brazil

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2C7

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N3Z5

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4T 3A7

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2N2

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 5B1

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1T8

Country

Canada

Facility Name

GSK Investigational Site

City

Puente Alto - Santiago

State/Province

Región Metro De Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

GSK Investigational Site

City

Santiago

State/Province

Región Metro De Santiago

ZIP/Postal Code

8320000

Country

Chile

Facility Name

GSK Investigational Site

City

Santiago

State/Province

Región Metro De Santiago

ZIP/Postal Code

8330074

Country

Chile

Facility Name

GSK Investigational Site

City

Santiago

State/Province

Región Metro De Santiago

ZIP/Postal Code

8900088

Country

Chile

Facility Name

GSK Investigational Site

City

Santiago

ZIP/Postal Code

8360159

Country

Chile

Facility Name

GSK Investigational Site

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Facility Name

GSK Investigational Site

City

Garches

ZIP/Postal Code

92380

Country

France

Facility Name

GSK Investigational Site

City

Le Kremlin Bicêtre cedex

ZIP/Postal Code

94275

Country

France

Facility Name

GSK Investigational Site

City

Le Kremlin-Bicêtre Cedex

ZIP/Postal Code

94275

Country

France

Facility Name

GSK Investigational Site

City

Marseille

ZIP/Postal Code

13009

Country

France

Facility Name

GSK Investigational Site

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

GSK Investigational Site

City

Orléans

ZIP/Postal Code

45100

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 20

ZIP/Postal Code

75970

Country

France

Facility Name

GSK Investigational Site

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

GSK Investigational Site

City

Tourcoing cedex

ZIP/Postal Code

59208

Country

France

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

161 21

Country

Greece

Facility Name

GSK Investigational Site

City

Piraeus

ZIP/Postal Code

18536

Country

Greece

Facility Name

GSK Investigational Site

City

Rio, Patras

ZIP/Postal Code

26504

Country

Greece

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

GSK Investigational Site

City

Modena

State/Province

Emilia-Romagna

ZIP/Postal Code

41100

Country

Italy

Facility Name

GSK Investigational Site

City

Busto Arsizio (VA)

State/Province

Lombardia

ZIP/Postal Code

21052

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20127

Country

Italy

Facility Name

GSK Investigational Site

City

Monza

State/Province

Lombardia

ZIP/Postal Code

20900

Country

Italy

Facility Name

GSK Investigational Site

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10149

Country

Italy

Facility Name

GSK Investigational Site

City

Cagliari

State/Province

Sardegna

ZIP/Postal Code

09121

Country

Italy

Facility Name

GSK Investigational Site

City

Cuautitlán, Estado De México

State/Province

Estado De México

ZIP/Postal Code

54800

Country

Mexico

Facility Name

GSK Investigational Site

City

León, Guanajuato

State/Province

Guanajuato

ZIP/Postal Code

37320

Country

Mexico

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44280

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico City

ZIP/Postal Code

03720

Country

Mexico

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3079 DZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Chorzow

ZIP/Postal Code

41-500

Country

Poland

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

021105

Country

Romania

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

030303

Country

Romania

Facility Name

GSK Investigational Site

City

Constanta

ZIP/Postal Code

900709

Country

Romania

Facility Name

GSK Investigational Site

City

Ekaterinburg

ZIP/Postal Code

620149

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Kazan

ZIP/Postal Code

420097

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Krasnodar

ZIP/Postal Code

350015

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

105275

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Facility Name

GSK Investigational Site

City

N.Novgorod

ZIP/Postal Code

603005

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Perm

ZIP/Postal Code

614088

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Ryazan

ZIP/Postal Code

390046

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

190103

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saratov

ZIP/Postal Code

410009

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Toliyatti

ZIP/Postal Code

445846

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Volgograd

ZIP/Postal Code

400040

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

GSK Investigational Site

City

Dundee

ZIP/Postal Code

3000

Country

South Africa

Facility Name

GSK Investigational Site

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

GSK Investigational Site

City

(Móstoles) Madrid

ZIP/Postal Code

28935

Country

Spain

Facility Name

GSK Investigational Site

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

GSK Investigational Site

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

GSK Investigational Site

City

Cartagena (Murcia)

ZIP/Postal Code

30202

Country

Spain

Facility Name

GSK Investigational Site

City

Elche (Alicante)

ZIP/Postal Code

03202

Country

Spain

Facility Name

GSK Investigational Site

City

Granada

ZIP/Postal Code

18003

Country

Spain

Facility Name

GSK Investigational Site

City

Granada

ZIP/Postal Code

18014

Country

Spain

Facility Name

GSK Investigational Site

City

Granollers (Barcelona)

ZIP/Postal Code

08400

Country

Spain

Facility Name

GSK Investigational Site

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28029

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Mataró

ZIP/Postal Code

08304

Country

Spain

Facility Name

GSK Investigational Site

City

Murcia

ZIP/Postal Code

30003

Country

Spain

Facility Name

GSK Investigational Site

City

Sabadell (Barcelona)

ZIP/Postal Code

08208

Country

Spain

Facility Name

GSK Investigational Site

City

San Sebastián

ZIP/Postal Code

20014

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41007

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

GSK Investigational Site

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

GSK Investigational Site

City

Valencia

ZIP/Postal Code

46015

Country

Spain

Facility Name

GSK Investigational Site

City

Kaohsiung

ZIP/Postal Code

813

Country

Taiwan

Facility Name

GSK Investigational Site

City

Kaohsiung

ZIP/Postal Code

824

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

406

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

GSK Investigational Site

City

Woolwich, London

State/Province

London

ZIP/Postal Code

SE18 4QH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Crumpsall, Manchester

ZIP/Postal Code

M8 5RB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Liverpool

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Tooting, London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing 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.

IPD Sharing 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 Sharing URL

http://clinicalstudydatarequest.com

Citations:

PubMed Identifier

23830355

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Infection, Human Immunodeficiency Virus, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial