NCT01068925

Drug Interaction Study Between GSK1349572 and Tipranavir/Ritonavir in Healthy Volunteers

An Open-Label, Single Sequence, Three-Period Drug Interaction Study of GSK1349572 and Tipranavir/Ritonavir in Healthy Adult Subjects (ING113096)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Detailed 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. ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Conditions

• Infection, Human Immunodeficiency Virus
• HIV Infections

Interventions

Type	Name	Description
DRUG	GSK1349572	1. GSK1349572 QD x 5 days 2. TPV/RTV 500/200mg BID x 7 days 3. GSK1349572 50mg QD and TPV/RTV 500/200mg BID x 5 days

Timeline

• Start date: 2010-02-15
• Primary completion: 2010-04-05
• Completion: 2010-04-05
• First posted: 2010-02-15
• Last updated: 2019-06-24

Locations

1 site across 1 country: United States