Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression
Status:Ongoing
Phase:IIb
Principal Investigator(s):GSK Clinical Trials
Objective:This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects.
Prevention Option(s):Cure
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionGSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks (Q8W)
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionGSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks (Q4W)
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionOral Control Arm
In the Induction Period of 20 weeks, subjects will receive an oral regimen of GSK744 30 mg once daily plus ABC/3TC 600/300 mg once daily.
Mode of Delivery
ARMs
Official Code:
NCT02120352
Trial Sponsors:
GSK, Janssen, ViiV
Start Date
End Date
April 22, 2014
December 22, 2020
Enrollment:310
Age range:
18 Years ↔
any
Population:Cisgender Men, Cisgender Women, People Living with HIV