Interaction Between Fosamprenavir/Ritonavir and a Single-dose Olanzapine (FORZA) (FORZA)
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|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 BID
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|