AIDS HIV-infection
Conditions
Interventions
For the determination of plasma drug concentrations, blood samples of 5 mL to
obtain at least 3.0 mL of plasma will be collected in heparinized hard plastic
tubes at the following time points: 0 (pr
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 on the day of the first dosing. 2. 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. 3. Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included. 4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. 5. Subject is in a 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, haematology and urinalysis testing should be within the laboratory's reference ranges (see Appendix A). If not, the subject is included on condition that the Investigator judges that the deviations are not clinically relevant. This should be clearly recorded. 6. Subject has a normal blood pressure and pulse rate, according to the Investiga-tor's judgement. 7. Female subject is either not of childbearing potential, defined as postmeno-pausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or copper intrauterine device (IUD); has a vasectomized partner; or total abstinence from sexual intercourse.
Exclusion criteria
Exclusion criteria: 1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipi-ents. 2. Positive HIV test. 3. Positive hepatitis B or C test. 4. Therapy with any drug, including oral contraceptives (for two weeks preceding dosing), except for paracetamol 5. Relevant history or presence of pulmonary disorders (especially COPD), car-diovascular disorders, neurological disorders (especially seizures and mi-graine), gastro-intestinal disorders, renal and hepatic disorders, hormonal dis-orders (especially diabetes mellitus), coagulation disorders. 6. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. 7. History of or current abuse of drugs, alcohol or solvents. 8. Inability to understand the nature and extent of the trial and the procedures required. 9. Participation in a drug trial within 60 days prior to the first dose. 10. Donation of blood within 60 days prior to the first dose. 11. Febrile illness within 3 days before the first dose 12. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics Individual and mean plasma concentrations will be presented. Overlay presentations will be given to illustrate inter-subject variability. Descriptive statistics will be calcu-lated for the plasma concentrations at each sampling time. The primary comparison will be made between AUC0-inf, Tmax and Cmax values of lopinavir and ritonavir after intake of the Reference regimen vs. after intake of the two Test regimens. Non-parametric analysis (Wilcoxon*s signed rank test) will be done for AUC, Cmax and Tmax values between the three different regimens. | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographics, Treatment Compliance, Concomitant Medication and Safety Data on demographics, treatment compliance, concomitant medication and safety of all subjects (including drop-outs) will be included in the clinical trial report. Demographics (including weight) and safety data at screening, laboratory safety data and concomitant medication will be listed. Descriptive statistics will be calculated for the subject characteristics. Adverse events and serious adverse events will be listed per treatment and the inci-dence (number of subjects with at least one AE) will be presented. Special attention will be given to subjects who discontinued because of AEs. | — |
Countries
Netherlands
Outcome results
None listed