drugset / Trial / NCT02589158

SSAT067 PK of Atazanavir/Cobicistat and Darunavir/Cobicistat

NCT02589158

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to look at the levels of three HIV medications: atazanavir, darunavir and cobicistat in the blood after 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 after taking them every day for 10 days. Participants will take Evotaz (atazanavir and cobicistat) on a first stage and Rezolsta (darunavir and cobicistat) on a second stage. If the participants decide to take part, the duration of the study will be up to 33 days plus a screening visit which will take place up to 28 days prior to the start of the study, and a follow up visit, which takes place 7 to 14 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 the participant is taking at all times during the study.

Timeline

Start
2015-11
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Atazanavir Other / unclassified 300 mg
Subject Cobicistat Small molecule 150 mg
Subject Darunavir Small molecule 800 mg