Pharmacokinetics of Tenofovir and Tenofovir-diphosphate, Emtricitabine and Emtricitabine-triphosphate, and Rilpivirine Once Daily Over 14 Days Following Drug Intake Cessation in Healthy Volunteers
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Plasma concentrations of tenofovir, emtricitabine and rilpivirine, and intracellular concentrations of tenofovir di-phosphate and emtricitabine tri-phosphate [ Time Frame: 23 days ] [ Designated as safety issue: Yes ]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
- Safety and tolerability of Eviplera® [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]To assess the safety and tolerability of Eviplera over 14 days in HIV negative healthy volunteers.
- Genetic polymorphisms and exposure to Eviplera® [ Time Frame: 23 Days ] [ Designated as safety issue: No ]To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure.
|Study Start Date:||March 2013|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796431
|St Stephen's AIDS Trust|
|London, United Kingdom, SW10 9NH|