The Pharmacokinetics of Dolutegravir, Darunavir/Cobocistat When Co-administered in Healthy Volunteers
Status:
Completed
Trial end date:
2018-03-17
Target enrollment:
Participant gender:
Summary
The purpose of this study is to look at the levels of three HIV medications: dolutegravir,
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 14 days.
There will be two groups. Participants in Group 1 will take dolutegravir everyday for 14
days, then nothing for 7 days, then dolutegravir and darunavir/cobicistat together for 14
days, nothing for 7 days, and then darunavir/cobicistat alone for 14 days. If participants go
into Group 2 they will begin with darunavir/cobicistat everyday for 14 days, then nothing for
7 days, then dolutegravir and darunavir/cobicistat together for 14 days, nothing for 7 days,
and then dolutegravir alone for 14 days. Drug levels for both groups will be measured on days
14, 35 and 56. If the participants decide to take part, the duration of the study will be up
to 57 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 15 to 22 days after the last dose of
study medication. Eligible participants will be randomized (1:1 ratio) to group 1 or group 2.
Participants and the study doctor will know which study medications the participant is taking
at all times during the study.