HIV human immunodeficiency virus
Conditions
Interventions
During this study, which lasts 67 days in total, subjects have to take study
medication during three treatment-periods which last 10 days each.
The 24 participants will be divided into 6 groups that
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Subject is at least 18 and not older than 55 years of age on the day of the first dosing. - Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first dosing. - Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes in-cluded. - Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. - Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to the first dose. Results of biochemistry, hae-matology and urinalysis testing should be within the laboratory's reference ranges (see Appendix A) 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. - Subject has a normal blood pressure and pulse rate, according to the Investigator's judgement.
Exclusion criteria
Exclusion criteria: - Documented history of sensitivity/idiosyncrasy to medicinal products or excipients. - Positive HIV test. - Positive hepatitis B or C test. - Pregnant female (as confirmed by an HCG test performed less than 4 weeks before the first dose) or breast-feeding female. -Therapy with any drug (for two weeks preceding dosing), except for paracetamol. - Subjects with an ECG with QTc interval greater than 450 msec for men, and greater than 470 msec for women at screening. -Relevant history or presence of pulmonary disorders (especially COPD), cardiovascu-lar disorders, neurological disorders (especially seizures and migraine), gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabe-tes mellitus), coagulation disorders. -Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. - History of or current abuse of drugs, alcohol or solvents. - Inability to understand the nature and extent of the trial and the procedures required. 11. Participation in a drug trial within 60 days prior to the first dose. 12. Donation of blood within 60 days prior to the first dose. 13. Febrile illness within 3 days before the first dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -To determine the effect of posaconazole on fosamprenavir pharmacokinetics (AUC, Cmax, Cmin) -To determine the effect of fosamprenavir on posaconazole pharmacokinetics (AUC, Cmax, Cmin) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Adverse effects which are either due to posaconazole, fosamprenavir/ ritonavir or combined use of posaconazole and fosamprenavir. | — |
Countries
Netherlands
Outcome results
None listed