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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000359-98 | EudraCT Number |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| MUC Research GmbH | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat |
|
| Group II | Active Comparator | Truvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir |
|
| Group III | Experimental | Truvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat | Drug | STRIBILD® QD, d1-14 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in metabolic parameters | Changes in lipid, metabolic hormons and "HOMA-IR", "Homa-beta", "QUICKIE" test. | Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph D Spinner, MD | University Hospital Klinikum rechts der Isar, Technische Universitaet Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Klinikum rechts der Isar (TUM) | Munich | Bavaria | 81675 | Germany |
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| Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir | Drug | Truvada®/ Kaletra® 200/50 mg QD, d1-14 |
|
|
| Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir | Drug | Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14 |
|
|
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068679 | Emtricitabine |
| D061466 | Lopinavir |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D000069547 | Cobicistat |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011744 | Pyrimidinones |
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