HIV
Conditions
Interventions
See study design.
3 different ways of administration of Triumeq:
- whole tablet
- crushed and suspended tablet
- standard amount of drip feed followed by a crushed and suspended tablet
Sponsors
Afdeling Apotheek
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 the day of screening; 2. Subject weighs at least 40 kg; 3. Subject has a BMI of 18.5-30 kg/m2, extremes included; 4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations; 5. Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, haematology and urinalysis testing within four weeks prior to day 1. Results of biochemistry, haematology 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 based on the Investigator*s judgment that the observed deviations are not clinically relevant. This should be clearly recorded; 6. Subject has a normal blood pressure and pulse rate, according to the Investigator*s judgment; 7. Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to day 1.
Exclusion criteria
Exclusion criteria: 1. Positive HIV test; 2. Positive hepatitis B or C test; 3. Positive HLA-B*5701 status; 4. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients; 5. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion; 6. Inability to understand the nature and extent of the study and the procedures required; 7. Pregnant female (as confirmed by an hCG test performed less than 4 weeks before day 1) or breast-feeding female. Female subjects of childbearing potential 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 study; 8. Therapy with any drug (including herbal remedies, multivitamins, magnesium- and calcium-containing supplements, etc.) (for two weeks preceding day 1), except for acetaminophen; 9. Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), psychiatric disorders, gastro-intestinal disorders, renal disorders (renal failure determined as an estimated Glomerular Filtration Rate (eGFR) below 50 ml/min (MDRD-based)), hepatic disorders (Child-Pugh B or C), hormonal disorders (especially diabetes mellitus), coagulation disorders; 10. History of or current abuse of drugs, alcohol or solvents; 11. Participation in a drug study within 60 days prior to day 1; 12. Donation of blood within 60 days prior to day 1; 13. Febrile illness within 3 days before day 1; 14. Co-worker of Radboud university medical center;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this study is to assess the bioequivalence of dolutegravir, abacavir and lamivudine administered as a whole tablet (reference) compared to a crushed and suspended tablet in a fasted state (intervention I) or after a standardized amount of drip feed (intervention II). Geometric Mean Ratios and the 90% confidence interval of the pharmacokinetic parameters AUC0-*, Cmax, and T* of intervention I compared to the reference treatment. Geometric Mean Ratios and the 90% confidence interval of the pharmacokinetic parameters AUC0-*, Cmax, and T* of intervention II compared to the reference treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary aim of this study is to assess the bioequivalence of dolutegravir, abacavir and lamivudine after dosing as a crushed and suspended tablet in a fasted state (intervention I) compared to a crushed and suspended tablet after a standardized amount of drip feed (intervention II). Geometric Mean Ratios and the 90% confidence interval of the pharmacokinetic parameters AUC0-*, Cmax, and T* of intervention I compared to intervention II. Adverse events after administration of a single-dose TRI in the different treatment arms will be described and compared (including clinically relevant laboratory abnormalities). | — |
Countries
Netherlands
Outcome results
None listed