Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of GSK1349572 (Dolutegravir, DTG) 50 mg Once Daily Compared to Darunavir/Ritonavir (DRV/r) 800 mg/100 mg Once Daily Each Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral naïve Adult Subjects
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 (approximately 234 subjects) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily (approximately 234 subjects), each in combination with fixed-dose dual nucleoside reverse transriptase inhibitor (NRTI) therapy (either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC). Subjects will be stratified by screening HIV-1 RNA and background NRTI selection. The primary analysis will take place after the last subject completes 48 weeks on therapy; an additional analysis will be conducted after the last subject completes Week 96 on study.
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 ART-naïve subjects. Subjects will be randomized 1:1 to receive DTG 50 mg once
daily (approximately 234 subjects) or DRV/r 800 mg/100 mg once daily (approximately 234
subjects), each in combination with fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC).
The primary analysis will take place after the last subject completes 48 weeks on therapy; an
additional analysis will be conducted after the last subject completes Week 96 on study.
Subjects who fulfil eligibility requirements will be randomized 1:1 to receive DTG 50 mg once
daily or DRV/r 800 mg/100 mg once daily. In order to achieve balance across the two treatment
groups of the study, randomization will be stratified by: screening plasma HIV-1 RNA >/
100,000 copies/mL (c/mL) or > 100,000 c/mL and background dual NRTI (ABC/3TC or TDF/FTC) The
DTG and DRV/r doses will be administered in an open-label fashion throughout the study.
Subjects randomized to receive DTG and who successfully complete 96 weeks of treatment will
continue to have access to DTG until either it is locally approved and commercially
available, the patient no longer derives clinical benefit, the patient meets a
protocol-defined reason for discontinuation or until development of DTG is terminated.
Subjects randomized to the DRV/r arm will receive DRV/r through their Week 96 visit, after
which they will be discontinued from the study and will need to make alternative arrangements
to access antiretroviral medication. All subjects will receive background dual-NRTI therapy
through their Week 96 visit.
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