drugset / Trial / NCT01796431

Pharmacokinetics of Tenofovir and Tenofovir-diphosphate, Emtricitabine and Emtricitabine-triphosphate, and Rilpivirine Once Daily Over 14 Days Following Drug Intake Cessation in Healthy Volunteers

NCT01796431

Phase 1 Completed 18 enrolled St Stephens Aids Trust
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-03
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilpivirine Small molecule
Subject Tenofovir disoproxil fumarate Small molecule
Subject emtricitabine Other / unclassified