HIV psychosis
Conditions
Interventions
Two groups are defined for treatment.
Group 1:
Day 1-16: Fosamprenavir/ritonavir 700/100 mg BD Day + olanzapine 15 mg
single-dose on Day 13
Day 17-47:wash-out
Day 48: single-dose olanzapine 10 mg
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is at least 18 and not older than 55 years of age at screening. 2. Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes in- cluded. 3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. 4. Subject is in good age-appropriate health condition as established by medical his-tory, physical examination, electrocardiography, results of biochemistry, haema-tology and urinalysis testing within 4 weeks prior to the first dose. Results of bio-chemistry, haematology and urinalysis testing should be within the laboratory's reference ranges. If laboratory results are not within the reference ranges, the subject is included on condition that the Investigator judges that the deviations are not clinically relevant. This should be clearly recorded. 5. Subject has a normal blood pressure and pulse rate, according to the Investiga-tor's judgement.
Exclusion criteria
Exclusion criteria: 1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients. 2. Positive HIV test. 3. Positive hepatitis B or C test. 4. Pregnant female (as confirmed by an HCG test performed less than 4 weeks be-fore the first dose) or breast-feeding female. Female subjects of childbearing po-tential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, (double) barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout the entire conduct of the trial. 5. Therapy with any drug (for two weeks preceding dosing), except for paracetamol. 6. Relevant history or presence of pulmonary disorders (especially COPD), cardio-vascular disorders, neurological disorders (especially seizures and migraine), gas-tro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders. 7. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. 8. History of or current abuse of drugs, alcohol or solvents. 9. Inability to understand the nature and extent of the trial and the procedures re-quired. 10. Participation in a drug trial within 60 days prior to the first dose. 11. Donation of blood within 60 days prior to the first dose. 12. Febrile illness within 3 days before the first dose 13. History of narrow-angle glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The influence of fosamprenavir/ritonavir on single-dose pharmacokinetics of olanzapine in healthy volunteers | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety of fosamprenavir/ritonavir combined with single-dose olanzapine in healthy volunteers | — |
Countries
Netherlands
Outcome results
None listed