This study will investigate changes in insulin sensitivity, lipid metabolism and endocrine profile in HIV-negative subjects exposed to Biktarvy (B/F/TAF) compared to subject not exposed to B/F/TAF for 28 days.
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 Biktarvy (B/F/TAF) compared to no B/F/TAF for 28 days in HIV seronegative healthy volunteers. Group 1: B/F/TAF tablet 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. B/F/TAF tablet 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide taken once daily, orally
Chelsea & Westminster Hospital NHS Foundation Trust
London, United Kingdom
Change in insulin sensitivity in participants from baseline to end of study between two crossover groups
Change in insulin sensitivity will be determined by peripheral glucose uptake using a euglycaemic clamp.
Time frame: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on adipocytokines
Fasting adiponectin and leptin levels in blood.
Time frame: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on fasting ghrelin
Fasting ghrelin levels in blood.
Time frame: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on pituitary hormones
Pituitary hormone function tests to measure blood levels of the following: Adrenocorticotrophic hormone (ACTH) Thyroid-stimulating hormone (TSH) Luteinising hormone (LH) Follicle-stimulating hormone (FSH) Prolactin (PRL) Melanocyte-stimulating hormone (MSH) Cortisol Insulin-like growth factors (IGFs)
Time frame: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on lipid profile including lipid fractions
Lipid profile in serum samples to measure blood levels of: Fasting cholesterol Triglycerides High-density lipoproteins (HDL) Low-density lipoproteins (LDL)
Time frame: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on changes in indirect calorimetry
Indirect calorimetry by ventilated hood expires gas analysis will be used to determine energy expenditure during the course of the clamp procedures.
Time frame: Baseline, day 28, 44, and 72 for both groups
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Effect of Biktarvy on changes in food intake
Changes measured food diaries completed 3 days prior to each trial visit.
Time frame: Baseline, day 28, 44, and 72 for both groups
Effect of Biktarvy on quality of sleep
Changes measured through the Pittsburgh Sleep Quality Index (PSQI). Questionnaire score ranges 0-21, with higher score indicating poorer sleep quality.
Time frame: Baseline, day 28, 44, and 72 for both groups