SSAT073 PK of Dolutegravir and Darunavir/Cobicistat
Research type
Research Study
Full title
The pharmacokinetics of dolutegravir, darunavir/cobicistat when co-administered in healthy volunteers
IRAS ID
206806
Contact name
Marta Boffito
Contact email
Sponsor organisation
St Stephen's AIDS Trust
Eudract number
2016-001277-32
Duration of Study in the UK
0 years, 7 months, 6 days
Research 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.REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/1871
Date of REC Opinion
22 Nov 2016
REC opinion
Further Information Favourable Opinion