Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by hyperinsulinemic euglycemic clamp.
The measurement of insulin resistance will be performed in 30 HIV-negative healthy non-obese (BMI 18-25) male volunteers before and after 14 days (+/- 2 days) of treatment with STRIBILD® (treatment 1, n=10), as compared to TVD, LPV/r (treatment 2, n=10) and TVD, DRV/r (treatment 3, n=10). The volunteers will be randomly assigned to one of three groups. The measurement of insulin resistance, lipid and glucose metabolism will be performed; before and immediately after the treatment. Furthermore, the therapy compliance will be verified using the method of drug counting and therapeutic drug monitoring (TDM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
STRIBILD® QD, d1-14
Truvada®/ Kaletra® 200/50 mg QD, d1-14
Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14
University Hospital Klinikum rechts der Isar (TUM)
Munich, Bavaria, Germany
Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp
Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by hyperinsulinemic euglycemic clamp.
Time frame: Day 14
Changes in metabolic parameters
Changes in lipid, metabolic hormons and "HOMA-IR", "Homa-beta", "QUICKIE" test.
Time frame: Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.