Status:
COMPLETED
Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Infection, Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy (ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg once daily (approximat...
Detailed Description
ING114915 is a Phase IIIb randomized, open-label, active-controlled, multicentre, parallel group, fully-powered non-inferiority study. The study will be conducted in approximately 468 HIV-1 infected A...
Eligibility Criteria
Inclusion
- HIV-1 infected adults greater than or equal to 18 years of age. Females are eligible to enter and participate in the study if she is (1) non-childbearing potential, (2) child bearing potential with negative pregnancy test at screening and Day 1 and agrees to use protocol-specified methods of birth control while on study.
- HIV-1 infection with a screening plasma HIV-1 RNA greater than or equal to 1000copies/mL
- Antiretroviral-naïve (less than or equal to 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection)
- Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening
Exclusion
- Women who are pregnant or breastfeeding
- Any evidence of an active Centers for Disease and Prevention Control (CDC) Category C disease \[CDC, 1993\], except cutaneous Kaposi's sarcoma not requiring systemic therapy
- Subjects with moderate to severe hepatic impairment (Class B or C) as determined by Child-Pugh classification
- Anticipated need for Hepatitis C virus (HCV) 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 the Study medical monitor for inclusion of the subject
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
- Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators
- Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product
- Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product
- Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation \[IAS-USA, 2010\] in the Screening result or, if known, any historical resistance test result
- Any verified Grade 4 laboratory abnormality. Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound is exclusionary
- Alanine aminotransferase (ALT) greater than 5 times the upper limit of normal
- ALT greater than 3 times the upper limit of normal and bilirubin greater than or equal to 1.5 times the upper limit of normal (with greater than 35% direct bilirubin)
- Subject has creatinine clearance of less than 50 mL/min via Cockroft-Gault method
- Recent history (less than or equal to 3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding
Key Trial Info
Start Date :
October 31 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2016
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT01449929
Start Date
October 31 2011
End Date
December 26 2016
Last Update
January 16 2018
Active Locations (66)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35294
2
GSK Investigational Site
Los Angeles, California, United States, 90027
3
GSK Investigational Site
Los Angeles, California, United States, 90069
4
GSK Investigational Site
Aurora, Colorado, United States, 80045