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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eviplera® | Experimental | Participants will take Eviplera every day for 14 days. Levels of the active ingredients, Tenofovir disoproxil fumarate, emtricitabine, rilpivirine hydrochloride will be measured in in blood after the drug intake has been stopped in order to understand how long these drugs persist in the blood. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eviplera® | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of tenofovir, emtricitabine and rilpivirine, and intracellular concentrations of tenofovir di-phosphate and emtricitabine tri-phosphate | 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 | 23 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of Eviplera® | To assess the safety and tolerability of Eviplera over 14 days in HIV negative healthy volunteers. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic polymorphisms and exposure to Eviplera® | To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure. | 23 Days |
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria within 28 days prior to the baseline visit:
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Stephen's AIDS Trust | London | London | SW10 9NH | United Kingdom |
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