HIV Infections Clinical Trial
Official title:
An Open-Label, Single Sequence, Three-Period Drug Interaction Study of GSK1349572 and Tipranavir/Ritonavir in Healthy Adult Subjects (ING113096)
The purpose of this study is to determine whether there is a drug interaction between GSK1349572 and the HIV protease inhibitors Tipranavir/Ritonavir (TPV/RTV).
The construction of a new antiretroviral regimen with GSK1349572 in raltegravir-resistant
subjects will likely require less commonly used agents such as tipranavir and enfuvirtide.
Ritonavir-boosted tipranavir (TPV/RTV) has been shown to induce drug metabolizing enzymes and
lead to decreased exposure of some antiretrovirals thus necessitating a drug interaction
study with GSK1349572 as GSK1349572 is eliminated primarily by metabolism.
This is a single-center, single sequence, open-label, three-period study, in adult male and
female healthy subjects. Approximately 18 subjects will receive GSK1349572 50mg QD for 5 days
(Treatment A). Subjects will then be administered TPV/RTV 500/200mg BID for 7 days (Treatment
B) followed by the combination of GSK1349572 50mg QD and TPV/RTV 500/200mg for 5 days
(Treatment C). There will be no washout periods between treatments. Safety evaluations will
be collected during each treatment period. Serial PK samples for GSK1349572 will be collected
and compared between Treatment A and C. A follow-up visit will occur 7-14 days after the last
dose of study drug.
The study will be conducted at one centre in the US with healthy adult male and female
subjects.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
updating systems to reflect the change in sponsorship.
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