SSAT061: PK of DTG and EVT/COBI in Healthy Volunteers
The purpose of the study is to look at the levels of three HIV medications: dolutegravir, elvitegravir and cobicistat 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 after taking them every day for 10 days dolutegravir on a first stage and a combination of elitegravir and cobicistat in a second stage.
If the participant decides to take part, the duration of the study will be up to 38 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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Pharmacokinetics of DOLUTEGRAVIR Once Daily and ELVITEGRAVIR/COBICISTAT Once Daily Over 10 Days Following Drug Intake Cessation in Healthy Volunteers|
- Steady state plasma concentrations of dolutegravir and elvitegravir/cobicistat after drug intake cessation up to 216 hours post-dose. [ Time Frame: 216 hours ] [ Designated as safety issue: No ]
On days 10 and 29: Serial blood specimens will be obtained from each participant for determining drug concentrations of dolutegravir or elvitegravir /cobicistat at the following time points: pre dose (within 10 minutes before dosing), 2, 4, 8 and 12 hours post dose (+/- 5 minutes time window for all post dose time points).
On days 11-12 and 30-31: Participants will have to attend the unit twice each day, in the mornings and evenings to provide the 24, 36, 48 and 60 hour post dose samples respectively, in order to determine drug concentrations.
On days 13 to 19 and 32 to 38: Blood will be drawn at the following time points: 72, 96, 120, 144, 168, 192 and 216 hours post last drug dose (dolutegravir and elvitegravir/cobicistat respectively).
|Study Start Date:||October 2014|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: No arms
All participants will be administered Tivicay® (dolutegravir 50 mg once daily) for 10 days, then will undergo a nine-day wash out period and then take Stribild® (245 mg of tenofovir disoproxil, 200 mg of emtricitabine, 150 mg of elvitegravir and 150 mg of cobicistat) for 10 days.
|Drug: Dolutegravir, Elvitegravir and Cobicistat|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02219217
|St Stephen's AIDS Trust|
|London, United Kingdom, SW10 9NH|