Interaction Between Fosamprenavir/Ritonavir and a Single-dose Olanzapine (FORZA) (FORZA)
|ClinicalTrials.gov Identifier: NCT00977301|
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : January 10, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: fosamprenavir/ritonavir Drug: olanzapine||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of FOsamprenavir/Ritonavir on the Pharmacokinetics of a Single-dose of the Antipsychotic Agent olanZApine (FORZA)|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
single dose of 15 mg olanzapine after 13 days of fosamprenavir/ritonavir 700mg/100mg BID
16 days 700mg/100mg RTV BIDDrug: olanzapine
15 mg olanzapine single dose
Active Comparator: single dose olanzapine
Single dose of 10 mg olanzapine
10 mg olanzapine single dose
- olanzapine concentrations [ Time Frame: pharmacokinetic curve after a single dose of olanzapine alone or added to steady state fosamprenavir/ritonavir ]
- adverse events [ Time Frame: entire study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977301
|CRCN, Radboud Universtity Nijmegen Medical Centre|
|Principal Investigator:||David Burger, PharmD, PhD||Radboud University|