Relative bioavailability study to investigate a potential interaction between dolutegravir (DTG) and tenofovir alafenamide fumarate/emtricitabine (F/TAF) administered as paediatric tablet formulations.
- Conditions
- HIV10047438
- Registration Number
- NL-OMON51616
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method