The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV -1 Infection
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Subjects will be randomised to start on dolutegravir 50 mg once daily OR no treatment for the first 28 day dosing phase of the study then will cross over to the alternative for the second dosing phase, following a 2 week washout period (equivalent to 5+ dolutegravir elimination half-lives).Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
Description
A randomised, crossover study investigating the difference in changes in insulin sensitivity (determined by peripheral glucose uptake using a euglycaemic clamp) with the administration of dolutegravir (DTG) compared to no DTG for 28 days in HIV seronegative healthy volunteers. Participants will be r...
A randomised, crossover study investigating the difference in changes in insulin sensitivity (determined by peripheral glucose uptake using a euglycaemic clamp) with the administration of dolutegravir (DTG) compared to no DTG for 28 days in HIV seronegative healthy volunteers. Participants will be randomised 1:1 to one of two arms: Group 1: Dolutegravir 50 mg once daily for the first 28 days of the study. No treatment for the last 44 days of the study. Group 2: No treatment for the first 28 days of the study. Dolutegravir 50 mg once daily for the last 28 days of the study (day 44-72). Research bloods, endocrine profiles, weight and urine samples will be collected at baseline, as well as day 28, 44, and 72 to enable comparative analyses. Participants will be closely monitored whilst taking the study medications. Participants will exit the study 72 days post-randomisation, with a follow-up call 28 days after exiting.
Tracking Information
- NCT #
- NCT04771754
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ana Milinkovic Chelsea and Westminster Hospital
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