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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | November 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: fosamprenavir/ritonavir/olanzapine
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
|
|
Active Comparator: single dose olanzapine
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| Netherlands | |
| CRCN, Radboud Universtity Nijmegen Medical Centre | |
| Nijmegen, Netherlands | |
| Principal Investigator: | David Burger, PharmD, PhD | Radboud University |
More Information
| Responsible Party: | D.M. Burger, PharmD, PhD, Radboud University Nijmegen Medical Centre |
| ClinicalTrials.gov Identifier: | NCT00977301 History of Changes |
| Other Study ID Numbers: | UMCN-AKF 08.04 |
| Study First Received: | August 17, 2009 |
| Last Updated: | January 7, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
HIV infection interaction pharmacokinetics |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Antipsychotic Agents Olanzapine Ritonavir Fosamprenavir |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents |