A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects
ING112276
A Phase IIb Study to Select a Once Daily Dose of GSK1349572 Administered With Either Abacavir/Lamivudine or Tenofovir/Emtricitabine in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects
1 other identifier
interventional
208
6 countries
35
Brief Summary
This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2009
Longer than P75 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2009
CompletedStudy Start
First participant enrolled
July 30, 2009
CompletedFirst Posted
Study publicly available on registry
August 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2010
CompletedResults Posted
Study results publicly available
November 11, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2016
CompletedJanuary 16, 2018
April 1, 2017
7 months
July 30, 2009
August 22, 2013
December 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16
Plasma samples were collected for quantitative HIV-1 RNA analysis at Week 16. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (\<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason. Data are reported per the Week 16 report. In later cuts of the data, the Week 16 values may have changed (because of the nature of the TLOVR algorithm).ITT-E Population included all randomized participants who received at least one dose of study medication
Week 16
Secondary Outcomes (21)
Viral Change Over the Initial 2 Weeks of Treatment
Baseline and Week 2
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96
Number of Participants With New HIV-associated Conditions of the Indicated Class
From Baseline up to Week 96
Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)
From Baseline up to Week 96
- +16 more secondary outcomes
Other Outcomes (1)
Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at the Indicated Time Points
Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96
Study Arms (4)
10 mg GSK1349572
EXPERIMENTALsubjects will receive GSK1349572 10mg once daily blinded to dose
25mg GSK1349572
EXPERIMENTALsubjects will receive GSK1349572 25mg once daily blinded to dose
50mg GSK1349572
EXPERIMENTALsubjects will receive GSK1349572 50mg once daily blinded to dose
efavirenz control
OTHERefavirenz will serve as the internal control arm
Interventions
investigational HIV-1 integrase inhibitor
approved therapy for HIV-1 infection, used as an internal study control
Eligibility Criteria
You may qualify if:
- HIV-1 infected male or female 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 with a screening plasma HIV-1 RNA greater than or equal to 1000copies/mL;
- CD4+ cell count greater than or equal to 200cells/mm3 (or higher as local guidelines dictate);
- No evidence of viral resistance to any antiretroviral drug indicative of primary transmitted resistance at screening;
- Able to understand and comply with protocol requirements;
- Able to provide written informed consent prior to screening;
- Note: Subjects starting abacavir as part of the NRTI backbone must have been screened and be negative for the HLA-B\*5701 allele.
You may not qualify if:
- Any pre-existing or serious mental or physical disorder which could compromise ability to comply with the protocol or compromise subject safety;
- Women who are pregnant or breastfeeding;
- An active AIDS-defining condition at the screening visit;
- Previous participation in an experimental drug and/or vaccine trial(s) within 30 days or 5 half-lives;
- Any condition which could interfere with the absorption, distribution, metabolism or excretion of the drug;
- Any acute or Grade 4 laboratory abnormality at screening;
- History of upper gastrointestinal bleed and/or subjects with active peptic ulcer disease;
- Estimated creatinine clearance \<50 mL/min;
- Alanine aminotransferase (ALT) greater than or equal to 5 times ULN;
- Alanine aminotransferase (ALT) greater than or equal to 3xULN and bilirubin greater than or equal to 1.5xULN (with \>35% direct bilirubin);
- Lipase greater than or equal to 3xULN;
- Hemoglobin \< 100 g/L(10 g/dL);
- History of allergy to the study drugs or their components or drugs of their class;
- Treatment with radiation therapy, cytotoxic chemotherapeutic agents, any agents with activity against HIV-1 or immunomodulators within 28 days prior to screening;
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days prior to screening;
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- Shionogicollaborator
- GlaxoSmithKlinecollaborator
Study Sites (35)
GSK Investigational Site
Phoenix, Arizona, 85012, United States
GSK Investigational Site
Bakersfield, California, 93301, United States
GSK Investigational Site
Long Beach, California, 90813, United States
GSK Investigational Site
San Francisco, California, 94115, United States
GSK Investigational Site
Denver, Colorado, 80209, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20037, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33306, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Orlando, Florida, 32804, United States
GSK Investigational Site
Santa Fe, New Mexico, 87505, United States
GSK Investigational Site
Charlotte, North Carolina, 28209, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Lyon, 69317, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Paris, 75018, France
GSK Investigational Site
Paris, 75475, France
GSK Investigational Site
Paris, 75651, France
GSK Investigational Site
Frankfurt am Main, Hesse, 60311, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30625, Germany
GSK Investigational Site
Hamburg, 20146, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
Bergamo, Lombardy, 24127, Italy
GSK Investigational Site
Brescia, Lombardy, 25123, Italy
GSK Investigational Site
Milan, Lombardy, 20127, Italy
GSK Investigational Site
Milan, Lombardy, 20157, Italy
GSK Investigational Site
Saint Petersburg, 190103, Russia
GSK Investigational Site
Saint Petersburg, 196645, Russia
GSK Investigational Site
Smolensk, 214006, Russia
GSK Investigational Site
Badalona, 08916, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Madrid, 28034, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Madrid, 28046, Spain
Related Publications (1)
van Lunzen J, Maggiolo F, Arribas JR, Rakhmanova A, Yeni P, Young B, Rockstroh JK, Almond S, Song I, Brothers C, Min S. Once daily dolutegravir (S/GSK1349572) in combination therapy in antiretroviral-naive adults with HIV: planned interim 48 week results from SPRING-1, a dose-ranging, randomised, phase 2b trial. Lancet Infect Dis. 2012 Feb;12(2):111-8. doi: 10.1016/S1473-3099(11)70290-0. Epub 2011 Oct 20.
PMID: 22018760BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- ViiV Healthcare
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
ViiV Healthcare
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2009
First Posted
August 3, 2009
Study Start
July 30, 2009
Primary Completion
February 26, 2010
Study Completion
December 22, 2016
Last Updated
January 16, 2018
Results First Posted
November 11, 2013
Record last verified: 2017-04