NCT02203461

Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Insulin Resistance

Interventions

Type	Name	Description
DRUG	Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat	STRIBILD® QD, d1-14
DRUG	Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir	Truvada®/ Kaletra® 200/50 mg QD, d1-14
DRUG	Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir	Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-07-30
• Last updated: 2014-11-05

Locations

1 site across 1 country: Germany