Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Phase I, Open Label, Randomized, Two Cohort, Two Period, Oneway Study to Evaluate the Effect of Boceprevir and Telaprevir onDolutegravir Pharmacokinetics in Healthy Adult Subjects (ING115697)
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3
clinical development for the treatment of human immunodeficiency virus (HIV) infection.
Co-infection with Hepatitis C (HCV) is common in HIV-infected subjects therefore it is
expected that DTG will be coadministered with treatments for HCV. Boceprevir (BCV) and
Telaprevir (TVR) are protease inhibitors for the treatment of HCV that were recently
approved by the Food and Drug Administration/European Medicines Agency (FDA/EMA) and have
rapidly been adopted to "standard of care" in combination with pegylated interferon and
ribavarin. This is a single-center, open-label, two-cohort, two-period, one-way, study in
healthy adult subjects. A total of approximately 32 subjects will be enrolled, in order to
obtain 24 evaluable subjects (12 per cohort). In the first treatment period, all subjects
will receive DTG 50 mg once daily for 5 days (treatment A). In period 2, subjects will
receive DTG 50 mg once daily plus either BCV 800 mg q8h (treatment B) for 10 days or TVR 750
mg q8h (treatment C) for 10 days. There will be no washout between treatments. Safety
evaluations and serial PK samples will be collected during each treatment period.
Subjects will have a screening visit within 30 days prior to the first dose of study drug,
two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug.
This study will be conducted at one center in the US, with healthy adult male and female
subjects.
n/a
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