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A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily (SPRING-2)

Primary Purpose

Infection, Human Immunodeficiency Virus I

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

GSK1349572 (dolutegravir)

raltegravir

GSK1349572 Placebo

ABC/3TC

TDF/FTC

raltegravir Placebo

About this trial

This is an interventional treatment trial for Infection, Human Immunodeficiency Virus I focused on measuring integrase inhibitor, HIV Infection, raltegravir, GSK1349572

Eligibility Criteria

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

Inclusion Criteria:

Screening plasma HIV-1 RNA ≥1000 c/mL
Antiretroviral-naïve (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection)
Ability to understand and sign a written informed consent form
Willingness to use approved methods of contraception to avoid pregnancy (women of child bearing potential only)
Age equal to or greater than 18 years

Exclusion Criteria:

Women who are pregnant or breastfeeding;
Active Center for Disease and Prevention Control (CDC) Category C disease
Moderate to severe hepatic impairment
Anticipated need for HCV therapy during the study
Allergy or intolerance to the study drugs or their components or drugs of their class
Malignancy within the past 5 years
Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening
Exposure to an agent with documented activity against HIV-1 in vitro or an experimental vaccine or drug within 28 days of first dose of study medication
Primary viral resistance in the Screening result
Verified Grade 4 laboratory abnormality
ALT >5 xULN
ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin);
Estimated creatinine clearance <50 mL/min
Recent history (≤3 months) of upper or lower gastrointestinal bleed

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GSK1349572 (N=~394)

raltegravir (N=~394)

Arm Description

GSK1349572 50mg once daily + raltegravir placebo twice daily + NRTI background therapy once daily

raltegravir 400mg twice daily + GSK1349572 placebo once daily + NRTI background therapy once daily

Outcomes

Primary Outcome Measures

Percentage of Participants With Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 Copies (c)/Milliliter (mL) Through Week 48

Percentage of participants with plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) with <50 c/mL was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. The algorithm treats all participants without HIV-1 RNA data as non-responders, as well as participants who switch their concomitant Antiretroviral Therapy (ART) prior to Week 48 as follows: background ART substitutions not permitted per study; background ART substitutions permitted per study 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 will be determined by the last available HIV-1 RNA assessment while the subject was on-treatment. Intent-to-Treat Exposed (ITT-E) Population comprised all randomized participants who received at least one dose of study medication.

Secondary Outcome Measures

Number of Participants With Detectable HIV-1 Virus That Has Genotypic or Phenotypic Evidence of INI Resistance.

Number of participants with detectable virus that has genotypic or phenotypic evidence of Integrase Inhibitor (INI) resistance were assessed at Week 48 and Week 96. Integrase inhibitors are a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the deoxyribonucleic acid (DNA) of the host cell.

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

The number of participants with plasma HIV-1 RNA level <50 c/mL was assessed at Week 96.

Number of Participants With Plasma HIV-1 RNA <400 c/mL

The number of participants with plasma HIV-1 RNA level <400 c/mL was assessed at Week 48 and Week 96.

Change From Baseline in Plasma HIV-1 RNA Over Time

Change from Baseline in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as the measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).

Absolute Values in Plasma HIV-1 RNA Over Time

Absolute values in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).

Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time

CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the participants disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start ART. Changes from Baseline in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).

Absolute Values in CD4+ Cell Counts Over Time

CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy absolute values in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).

Number of Participants With the Indicated Post-Baseline HIV-associated Conditions and Progression, Excluding Recurrences

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 to a CDC CAT C event (EV); CDC CAT B at Baseline to a CDC CAT C EV; CDC CAT C at Baseline to a new CDC CAT C EV; or CDC CAT A, B, or C at Baseline to death.

Number of Participants With the Indicated Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)

All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), 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, phosphorus inorganic, 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. Safety Population: all participants who received at least one dose of investigational product

Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau [AUC(0-tau)] of DTG

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. The predicted individual AUC(0-tau) were obtained from the final population PK model by an empirical Bayes estimation. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hours post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa. The Pharmacokinetic (PK) Concentration Population comprised of all participants who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.

Maximum Plasma Concentration (Cmax) and Concentration at the End of a Dosing Interval (Ctau) of DTG

The maximum plasma concentration (Cmax) and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Week 48. The predicted individual Cmax and Ctau were obtained from the final population PK model by simulation of the concentration-time profiles. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hour post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa.

Full Information

NCT ID

NCT01227824

First Posted

October 14, 2010

Last Updated

October 4, 2018

Sponsor

ViiV Healthcare

Collaborators

Shionogi, GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01227824

Brief Title

A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily

Acronym

SPRING-2

Official Title

A Randomized, Double Blind Study of the Safety and Efficacy of GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily Both Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

October 19, 2010 (undefined)

Primary Completion Date

February 6, 2012 (Actual)

Study Completion Date

December 27, 2016 (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

The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult subjects.

Detailed Description

ING113086 is a Phase 3 randomized, double-blind, double dummy, active-controlled, multicenter, study conducted in approximately 788 HIV-1 infected ART-naïve subjects. Subjects will be randomized 1:1 one of the following treatment arms: GSK1349572 50 mg once daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC) OR 400 mg RAL twice daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC) Analyses will be conducted at 48 weeks and 96 weeks. Subjects randomized to receive GSK1349572 and who successfully complete 96 weeks of treatment will continue to have access to GSK1349572 through the study until either it is locally available, as long as they continue to derive clinical benefit. ViiV Healthcare is the new 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 I

Keywords

integrase inhibitor, HIV Infection, raltegravir, GSK1349572

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

828 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK1349572 (N=~394)

Arm Type

Experimental

Arm Description

GSK1349572 50mg once daily + raltegravir placebo twice daily + NRTI background therapy once daily

Arm Title

raltegravir (N=~394)

Arm Type

Active Comparator

Arm Description

raltegravir 400mg twice daily + GSK1349572 placebo once daily + NRTI background therapy once daily

Intervention Type

Drug

Intervention Name(s)

GSK1349572 (dolutegravir)

Intervention Description

GSK1349572 50 mg taken once daily with or without food

Intervention Type

Drug

Intervention Name(s)

raltegravir

Intervention Description

raltegravir 400mg taken twice daily

Intervention Type

Other

Intervention Name(s)

GSK1349572 Placebo

Intervention Description

GSK1349572 placebo taken once daily

Intervention Type

Other

Intervention Name(s)

ABC/3TC

Intervention Description

Abacavir/Lamivudine background therapy once daily

Intervention Type

Other

Intervention Name(s)

TDF/FTC

Intervention Description

Tenofovir/emtricitabine background therapy once daily

Intervention Type

Other

Intervention Name(s)

raltegravir Placebo

Intervention Description

raltegravir placebo taken twice daily

Primary Outcome Measure Information:

Title

Percentage of Participants With Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 Copies (c)/Milliliter (mL) Through Week 48

Description

Time Frame

Baseline up to Week 48

Secondary Outcome Measure Information:

Title

Number of Participants With Detectable HIV-1 Virus That Has Genotypic or Phenotypic Evidence of INI Resistance.

Description

Time Frame

Week 48 and Week 96

Title

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

Description

The number of participants with plasma HIV-1 RNA level <50 c/mL was assessed at Week 96.

Time Frame

Week 96

Title

Number of Participants With Plasma HIV-1 RNA <400 c/mL

Description

The number of participants with plasma HIV-1 RNA level <400 c/mL was assessed at Week 48 and Week 96.

Time Frame

Week 48 and Week 96

Title

Change From Baseline in Plasma HIV-1 RNA Over Time

Description

Time Frame

Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96

Title

Absolute Values in Plasma HIV-1 RNA Over Time

Description

Time Frame

Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96

Title

Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time

Description

Time Frame

Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96

Title

Absolute Values in CD4+ Cell Counts Over Time

Description

CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy absolute values in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).

Time Frame

Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96

Title

Number of Participants With the Indicated Post-Baseline HIV-associated Conditions and Progression, Excluding Recurrences

Description

Time Frame

From Baseline until Week 96

Title

Number of Participants With the Indicated Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)

Description

Time Frame

From Baseline until Week 96

Title

Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau [AUC(0-tau)] of DTG

Description

Time Frame

Week 4, Week 24, and Week 48

Title

Maximum Plasma Concentration (Cmax) and Concentration at the End of a Dosing Interval (Ctau) of DTG

Description

Time Frame

Week 4, Week 24, and Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Screening plasma HIV-1 RNA ≥1000 c/mL Antiretroviral-naïve (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) Ability to understand and sign a written informed consent form Willingness to use approved methods of contraception to avoid pregnancy (women of child bearing potential only) Age equal to or greater than 18 years Exclusion Criteria: Women who are pregnant or breastfeeding; Active Center for Disease and Prevention Control (CDC) Category C disease Moderate to severe hepatic impairment Anticipated need for HCV therapy during the study Allergy or intolerance to the study drugs or their components or drugs of their class Malignancy within the past 5 years Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening Exposure to an agent with documented activity against HIV-1 in vitro or an experimental vaccine or drug within 28 days of first dose of study medication Primary viral resistance in the Screening result Verified Grade 4 laboratory abnormality ALT >5 xULN ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin); Estimated creatinine clearance <50 mL/min Recent history (≤3 months) of upper or lower gastrointestinal bleed

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

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

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

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

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

GSK Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

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

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

Atlanta

State/Province

Georgia

ZIP/Postal Code

30339

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

Hillsborough

State/Province

New Jersey

ZIP/Postal Code

08844

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

Columbia

State/Province

South Carolina

ZIP/Postal Code

29203

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

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

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

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

GSK Investigational Site

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

GSK Investigational Site

City

Surry Hills

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

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 1Y6

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

GSK Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

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

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 5B1

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 2P4

Country

Canada

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

Levallois Perret

ZIP/Postal Code

92300

Country

France

Facility Name

GSK Investigational Site

City

Lyon Cedex 03

ZIP/Postal Code

69437

Country

France

Facility Name

GSK Investigational Site

City

Marseille

ZIP/Postal Code

13003

Country

France

Facility Name

GSK Investigational Site

City

Nantes

ZIP/Postal Code

44093

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 12

ZIP/Postal Code

75571

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 4

ZIP/Postal Code

75181

Country

France

Facility Name

GSK Investigational Site

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

GSK Investigational Site

City

Fuerth

State/Province

Bayern

ZIP/Postal Code

90762

Country

Germany

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80335

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60596

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Facility Name

GSK Investigational Site

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53127

Country

Germany

Facility Name

GSK Investigational Site

City

Dortmund

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44137

Country

Germany

Facility Name

GSK Investigational Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20146

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

GSK Investigational Site

City

Cona (Ferrara)

State/Province

Emilia-Romagna

ZIP/Postal Code

44124

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

GSK Investigational Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16128

Country

Italy

Facility Name

GSK Investigational Site

City

Brescia

State/Province

Lombardia

ZIP/Postal Code

25123

Country

Italy

Facility Name

GSK Investigational Site

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10149

Country

Italy

Facility Name

GSK Investigational Site

City

Rovigo

State/Province

Veneto

ZIP/Postal Code

45100

Country

Italy

Facility Name

GSK Investigational Site

City

Krasnodar

ZIP/Postal Code

350015

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Lipetsk

ZIP/Postal Code

398043

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

105275

Country

Russian Federation

Facility Name

GSK Investigational Site

City

N.Novgorod

ZIP/Postal Code

603005

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Orel

ZIP/Postal Code

302040

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Perm

ZIP/Postal Code

614088

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saratov

ZIP/Postal Code

410009

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Smolensk

ZIP/Postal Code

214006

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

190103

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

196645

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Volgograd

ZIP/Postal Code

400040

Country

Russian Federation

Facility Name

GSK Investigational Site

City

(Móstoles) Madrid

ZIP/Postal Code

28935

Country

Spain

Facility Name

GSK Investigational Site

City

Alcala de Henares

ZIP/Postal Code

28805

Country

Spain

Facility Name

GSK Investigational Site

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

GSK Investigational Site

City

Almería

ZIP/Postal Code

04009

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

08003

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

08036

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

GSK Investigational Site

City

Cartagena (Murcia)

ZIP/Postal Code

30202

Country

Spain

Facility Name

GSK Investigational Site

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

GSK Investigational Site

City

Granada

ZIP/Postal Code

18014

Country

Spain

Facility Name

GSK Investigational Site

City

Granada

Country

Spain

Facility Name

GSK Investigational Site

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

GSK Investigational Site

City

La Laguna (Santa Cruz De Tenerife)

ZIP/Postal Code

38320

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

28034

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

28041

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

GSK Investigational Site

City

Mataró

ZIP/Postal Code

08304

Country

Spain

Facility Name

GSK Investigational Site

City

Murcia

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

41071

Country

Spain

Facility Name

GSK Investigational Site

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

GSK Investigational Site

City

Vigo ( Pontevedra)

ZIP/Postal Code

36204

Country

Spain

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Warwickshire

ZIP/Postal Code

B29 6JD

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Brighton

ZIP/Postal Code

BN2 1ES

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

London

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

SW10 9TH

Country

United Kingdom

12. IPD Sharing Statement

Citations:

Citation

Brinson C, Walmsley S, Arasteh K, et al. Dolutegravir treatment response and safety by key subgroups in treatment naive HIV-infected individuals. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.

Results Reference

background

PubMed Identifier

23306000

Citation

Raffi F, Rachlis A, Stellbrink HJ, Hardy WD, Torti C, Orkin C, Bloch M, Podzamczer D, Pokrovsky V, Pulido F, Almond S, Margolis D, Brennan C, Min S; SPRING-2 Study Group. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013 Mar 2;381(9868):735-43. doi: 10.1016/S0140-6736(12)61853-4. Epub 2013 Jan 8.

Results Reference

background

PubMed Identifier

24074642

Citation

Raffi F, Jaeger H, Quiros-Roldan E, Albrecht H, Belonosova E, Gatell JM, Baril JG, Domingo P, Brennan C, Almond S, Min S; extended SPRING-2 Study Group. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2013 Nov;13(11):927-35. doi: 10.1016/S1473-3099(13)70257-3. Epub 2013 Sep 25.

Results Reference

derived

Learn more about this trial

A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily

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A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily (SPRING-2)

Infection, Human Immunodeficiency Virus I

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