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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.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Infection, Human Immunodeficiency Virus
GSK Investigational Site
Published on BioPortfolio: 2014-08-27T03:15:54-0400
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Proteins encoded by the REV GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Proteins encoded by the TAT GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Proteins encoded by the VPR GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Proteins encoded by the VIF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Proteins encoded by the NEF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
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AIDS and HIV
AIDS; Acquired Immune Deficiency Syndrome. HIV; Human Immunodeficiency Virus HIV infection causes AIDS. HIV infection also causes the production of anti-HIV antibodies, which forms the test for HIV in patients. People who have the HIV antibodies are ...