HIV
Conditions
Brief summary
The purpose of the study is to look at the levels of three HIV medications: tenofovir, emtricitabine, and rilpivirine in blood after the drug intake has been stopped in order to understand how long these drugs persist in the blood. The study will specifically look at blood levels of these three drugs (taken as a 3-in-1 tablet) after taking them every day for 14 days. The duration of the subjects involvement in the study will be up to 23 days plus a screening visit which will take place up to 4 weeks prior to the start of the study, and a follow up visit which takes place 16-22 days after the last dose of study medication. This study is not randomised which means that all participants will receive all study medications in the same order. The participant and the study doctor will know which study medications you are taking at all times during the study.
Interventions
DRUGEviplera®
Sponsors
St Stephens Aids Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet all of the following inclusion criteria within 28 days prior to the baseline visit: * The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements * Male or non-pregnant, non-lactating females * Between 18 to 65 years, inclusive * Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive * Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 12 weeks after the study * Willing to consent to their personal details being entered onto The Over-volunteering Prevention Scheme (TOPS) database * Willing to provide photographic identification at each visit * Registered with a GP in the UK
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations of tenofovir, emtricitabine and rilpivirine, and intracellular concentrations of tenofovir di-phosphate and emtricitabine tri-phosphate | 23 days | To assess the pharmacokinetics of plasma tenofovir (TFV) and emtricitabine (FTC), and their active intracellular anabolites, tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP), and plasma rilpivirine over 14 days following drug intake cessation, in HIV negative healthy volunteers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of Eviplera® | 14 days | To assess the safety and tolerability of Eviplera over 14 days in HIV negative healthy volunteers. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Genetic polymorphisms and exposure to Eviplera® | 23 Days | To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure. |
Countries
United Kingdom
Outcome results
None listed