Status:
COMPLETED
A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
Shionogi
GlaxoSmithKline
Conditions:
Infection, Human Immunodeficiency Virus I
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. Bo...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 19 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2016
Estimated Enrollment :
828 Patients enrolled
Trial Details
Trial ID
NCT01227824
Start Date
October 19 2010
End Date
December 27 2016
Last Update
October 9 2018
Active Locations (101)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85012
2
GSK Investigational Site
Little Rock, Arkansas, United States, 72207
3
GSK Investigational Site
Long Beach, California, United States, 90813
4
GSK Investigational Site
Los Angeles, California, United States, 90048