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Interaction Between Fosamprenavir/Ritonavir and a Single-dose Olanzapine (FORZA)

2014-08-27 03:19:19 | BioPortfolio

Summary

The effect of fosamprenavir/ritonavir (steady state) on the pharmacokinetics of a single dose of olanzapine will be studied.

In this study, the investigators expect an inducible effect of fosamprenavir/ritonavir on the CYP1A2 and UGT metabolism of olanzapine.

Description

Psychosis and other mental illnesses are commonly described in patients infected with the human immunodeficiency virus (HIV). New-onset psychosis is estimated to occur in up to 15% of patients infected with HIV while 5 to 7% of patients with HIV-infection suffer from pre-existing mental illnesses including schizophrenia. Olanzapine could be an attractive antipsychotic in HIV/AIDS patients with schizophrenia.

Because olanzapine is a substrate for both UGT and CYP1A2, the pharmacokinetics of olanzapine might be influenced by low-dose ritonavir in combination with fosamprenavir. The current study is designed to test this hypothesis. Furthermore, in this study we evaluate the safety of such combination.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

HIV Infections

Intervention

fosamprenavir/ritonavir, olanzapine, olanzapine

Location

CRCN, Radboud Universtity Nijmegen Medical Centre
Nijmegen
Netherlands

Status

Recruiting

Source

Radboud University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:19-0400

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