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| Sponsor: | Radboud University |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00977301 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: fosamprenavir/ritonavir Drug: olanzapine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
| Official Title: | The Effect of FOsamprenavir/Ritonavir on the Pharmacokinetics of a Single-dose of the Antipsychotic Agent olanZApine (FORZA) |
| Estimated Enrollment: | 24 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
fosamprenavir/ritonavir/olanzapine: Experimental
single dose of 15 mg olanzapine after 13 days of fosamprenavir/ritonavir 700mg/100mg BID
|
Drug: fosamprenavir/ritonavir
16 days 700mg/100mg RTV BID
Drug: olanzapine
15 mg olanzapine single dose
|
|
single dose olanzapine: Active Comparator
Single dose of 10 mg olanzapine
|
Drug: olanzapine
10 mg olanzapine single dose
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: David Burger, PhD, PharmD | ++31 24 3616405 | d.burger@akf.umcn.nl |
| Netherlands | |
| CRCN, Radboud Universtity Nijmegen Medical Centre | |
| Nijmegen, Netherlands | |
| Principal Investigator: | David Burger, PharmD, PhD | Radboud University |
More Information
| Responsible Party: | Radboud University Nijmegen Medical Centre ( D.M. Burger, PharmD, PhD ) |
| Study ID Numbers: | UMCN-AKF 08.04 |
| Study First Received: | August 17, 2009 |
| Last Updated: | September 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00977301 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
HIV infection interaction pharmacokinetics |
|
Anti-Infective Agents Communicable Diseases Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Olanzapine Psychotropic Drugs Antiemetics Infection Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections |
HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Tranquilizing Agents Immune System Diseases Acquired Immunodeficiency Syndrome Gastrointestinal Agents Central Nervous System Depressants Enzyme Inhibitors Antipsychotic Agents Antiviral Agents Serotonin Uptake Inhibitors Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors |