Drug Interaction Study Between GSK1349572 and Tipranavir/Ritonavir in Healthy Volunteers
Summary
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).
Description
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.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Conditions
Infection, Human Immunodeficiency Virus
Intervention
GSK1349572
Location
GSK Investigational Site
Austin
Texas
United States
78744
Status
Recruiting
Source
GlaxoSmithKline
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01068925
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:15:54-0400
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Medical and Biotech [MESH] Definitions
Vpr Gene Products, Human Immunodeficiency Virus
Proteins encoded by the VPR GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Nef Gene Products, Human Immunodeficiency Virus
Proteins encoded by the NEF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Vif Gene Products, Human Immunodeficiency Virus
Proteins encoded by the VIF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Tat Gene Products, Human Immunodeficiency Virus
Proteins encoded by the TAT GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Rev Gene Products, Human Immunodeficiency Virus
Proteins encoded by the REV GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
