Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication
NCT02203461 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2014-11-05
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
- collaborator INDUSTRY
-
MUC Research GmbH
collaborator OTHER -
Technical University of Munich
lead OTHER
Principal Investigators
-
Christoph D Spinner, MD · University Hospital Klinikum rechts der Isar, Technische Universitaet Muenchen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-07-31
- Primary Completion
- 2014-10-31
- Completion
- 2014-10-31
Countries
- Germany
Study Locations
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