HIV
Conditions
Interventions
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 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. 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. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients. 4. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. 5. Inability to understand the nature and extent of the study and the procedures required. 6. 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. 7. Therapy with any drug (including herbal remedies, multivitamins, iron supplements and calcium supplements) for two weeks preceding day 1, except for acetaminophen. 8. 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. 9. History of or current abuse of drugs, alcohol or solvents. 10. Participation in a drug study within 60 days prior to day 1. 11. Donation of blood within 60 days prior to day 1. 12. Febrile illness within 3 days before day 1. 13. Co-worker of Radboud university medical center.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameters of this study are to assess: - The relative bioavailability of TAF and TFV after a single-dose FTC/TAF 3x 60/7.5mg DT (reference TAF) compared to TAF and TFV after a single-dose FTC/TAF 3x 60/7.5mg DT in combination with a single dose of DTG 30mg as 6 tablets of 5mg DT (test). - The relative bioavailability of FTC after a single-dose FTC/TAF 3x 60/7.5mg DT (reference FTC) compared to FTC after a single-dose FTC/TAF 3x 60/7.5mg DT in combination with a single dose of DTG 30 mg as 6 tablets of 5 mg DT (test). - The relative bioavailability of DTG after a single-dose DTG 30mg as 6 tablets of 5mg DT (reference DTG) compared to DTG after a single-dose FTC/TAF 3x 60/7.5mg DT in combination with a single dose of DTG 30mg as 6 tablets of 5mg DT (test). - The relative bioavailability of the potential interaction, the pharmacokinetics (AUC0-*, Cmax, Tmax, T*) of DTG, FTC, TAF and TFV and the geometric mean ratios of the AUC0-tlast (TAF), AUC0-* (DTG, FTC and TFV) and Cmax of the test versus reference treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety and tolerability of (co-)administration of DTG, FTC/TAF in healthy adult subjects. | — |
Countries
Netherlands
Outcome results
None listed