Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tenofovir disaproxil/emtricitabine/elvitegravir/cobicistat · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat | DRUG | STRIBILD® QD, d1-14 |
| 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 |
Inclusion Criteria: * Healthy male volunteers, age 18-40 years * Informed consent and willingness in study participation * Birth control during study period Exclusion Criteria: * Participation in other clinical trials * Contraindication or known allergy to study medication * Known metabolic disea...