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

NCT ID: NCT01227824

Last Updated: 2018-10-09

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

828 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-19

Study Completion Date

2016-12-27

Brief Summary

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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.

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Detailed Description

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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:

1. GSK1349572 50 mg once daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC)

OR
2. 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

Conditions

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Infection, Human Immunodeficiency Virus I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GSK1349572 (N=~394)

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

Group Type EXPERIMENTAL

GSK1349572 (dolutegravir)

Intervention Type DRUG

GSK1349572 50 mg taken once daily with or without food

GSK1349572 Placebo

Intervention Type OTHER

GSK1349572 placebo taken once daily

ABC/3TC

Intervention Type OTHER

Abacavir/Lamivudine background therapy once daily

TDF/FTC

Intervention Type OTHER

Tenofovir/emtricitabine background therapy once daily

raltegravir (N=~394)

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

Group Type ACTIVE_COMPARATOR

raltegravir

Intervention Type DRUG

raltegravir 400mg taken twice daily

ABC/3TC

Intervention Type OTHER

Abacavir/Lamivudine background therapy once daily

TDF/FTC

Intervention Type OTHER

Tenofovir/emtricitabine background therapy once daily

raltegravir Placebo

Intervention Type OTHER

raltegravir placebo taken twice daily

Interventions

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GSK1349572 (dolutegravir)

GSK1349572 50 mg taken once daily with or without food

Intervention Type DRUG

raltegravir

raltegravir 400mg taken twice daily

Intervention Type DRUG

GSK1349572 Placebo

GSK1349572 placebo taken once daily

Intervention Type OTHER

ABC/3TC

Abacavir/Lamivudine background therapy once daily

Intervention Type OTHER

TDF/FTC

Tenofovir/emtricitabine background therapy once daily

Intervention Type OTHER

raltegravir Placebo

raltegravir placebo taken twice daily

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shionogi

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

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GSK Investigational Site

Phoenix, Arizona, United States

Site Status

GSK Investigational Site

Little Rock, Arkansas, United States

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GSK Investigational Site

Long Beach, California, United States

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GSK Investigational Site

Los Angeles, California, United States

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GSK Investigational Site

Los Angeles, California, United States

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GSK Investigational Site

Torrance, California, United States

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GSK Investigational Site

Denver, Colorado, United States

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GSK Investigational Site

Washington D.C., District of Columbia, United States

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GSK Investigational Site

Fort Lauderdale, Florida, United States

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GSK Investigational Site

Ft. Pierce, Florida, United States

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GSK Investigational Site

Atlanta, Georgia, United States

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St Louis, Missouri, United States

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Hillsborough, New Jersey, United States

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Charlotte, North Carolina, United States

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GSK Investigational Site

Columbia, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Seattle, Washington, United States

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GSK Investigational Site

Darlinghurst, New South Wales, Australia

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Surry Hills, New South Wales, Australia

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Melbourne, Victoria, Australia

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Vancouver, British Columbia, Canada

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GSK Investigational Site

Hamilton, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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GSK Investigational Site

Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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GSK Investigational Site

Garches, , France

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Le Kremlin-Bicêtre, , France

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Levallois-Perret, , France

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Lyon, , France

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Marseille, , France

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Nantes, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Fürth, Bavaria, Germany

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Munich, Bavaria, Germany

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Frankfurt am Main, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Bonn, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Dortmund, North Rhine-Westphalia, Germany

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Berlin, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Cona (Ferrara), Emilia-Romagna, Italy

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Rome, Lazio, Italy

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Genoa, Liguria, Italy

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Brescia, Lombardy, Italy

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Turin, Piedmont, Italy

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Rovigo, Veneto, Italy

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Krasnodar, , Russia

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Lipetsk, , Russia

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Moscow, , Russia

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N.Novgorod, , Russia

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Oryol, , Russia

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Perm, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Smolensk, , Russia

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Volgograd, , Russia

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(Móstoles) Madrid, , Spain

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A Coruña, , Spain

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Alcalá de Henares, , Spain

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Alicante, , Spain

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Almería, , Spain

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Badalona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Cartagena (Murcia), , Spain

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Córdoba, , Spain

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Granada, , Spain

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Granada, , Spain

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La Laguna (Santa Cruz de Tenerife), , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Mataró, , Spain

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Málaga, , Spain

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Murcia, , Spain

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San Sebastián, , Spain

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Seville, , Spain

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GSK Investigational Site

Valencia, , Spain

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GSK Investigational Site

Vigo ( Pontevedra), , Spain

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GSK Investigational Site

Birmingham, Warwickshire, United Kingdom

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GSK Investigational Site

Brighton, , United Kingdom

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GSK Investigational Site

Crumpsall, Manchester, , United Kingdom

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GSK Investigational Site

London, , United Kingdom

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GSK Investigational Site

London, , United Kingdom

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Countries

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United States Australia Canada France Germany Italy Russia Spain United Kingdom

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 23306000 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24074642 (View on PubMed)

Other Identifiers

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113086

Identifier Type: -

Identifier Source: org_study_id

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