NCT00817765

Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteers.A second objective is to determine the safety of combined use of fosamprenavir with posaconazole in healthy volunteers.

Detailed description

Infections with fungi and yeast frequently occur in patients infected with the human immunodeficiency virus type 1 (HIV-1). Fosamprenavir is a PI that is used to treat HIV-infection in combination with ritonavir. Once hydrolyzed to amprenavir, this substance is a substrate for CYP3A4. Ritonavir is an extremely potent inhibitor of CYP3A4 and serves as a booster of the pharmacokinetics of amprenavir. Posaconazole is a very potent CYP3A4 inhibitor and therefore might enhance amprenavir pharmacokinetics in a similar way as ritonavir. The current study is designed to test this hypothesis. When there is an indication for antifungal therapy in an HIV-infected patient, temporal replacement of ritonavir by posaconazole would be an attractive option for combined treatment of HIV and fungal infection.

Conditions

• HIV Infection
• Fungal Infection

Interventions

Type	Name	Description
DRUG	Posaconazole	Posaconazole oral solution 40mg/mL; 400mg BID treatment for 10 days, including dose escalation
DRUG	Fosamprenavir	fosamprenavir tablet 700mg; 1 tablet BID for 10 days
DRUG	Ritonavir	Ritonavir 100mg capsule; 1 capsule BID for 10 days

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-07-01
• Completion: 2009-10-01
• First posted: 2009-01-06
• Last updated: 2020-11-12

Locations

1 site across 1 country: Netherlands