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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...
Tenofovir disaproxil/emtricitabine/elvitegravir/cobicistat is a fixed-dose combination of four small molecules developed by Gilead Sciences. It has been studied in a Phase 1 trial in healthy male volunteers for insulin resistance. The combination is also known as tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat.
Tenofovir disaproxil/emtricitabine/elvitegravir/cobicistat was evaluated in a Phase 1 study examining changes in insulin resistance in healthy volunteers. The trial enrolled 30 healthy male participants aged 18 years and older in Germany. The study is completed, and the combination is not approved for insulin resistance.
Gilead Sciences, Inc. (ticker GILD) develops tenofovir disaproxil/emtricitabine/elvitegravir/cobicistat. The company sponsored the Phase 1 insulin resistance study of the four-drug combination.
Tenofovir disaproxil/emtricitabine/elvitegravir/cobicistat is in Phase 1 development for insulin resistance. The single recorded trial, NCT02203461, is completed. The combination is investigational for this metabolic indication and is not approved for insulin resistance.
Tenofovir disaproxil/emtricitabine/elvitegravir/cobicistat has been studied in one trial, NCT02203461, titled Changes in Insulin Resistance in Healthy Volunteers on STRIBILD Medication. The Phase 1 trial was active-controlled, randomized, and enrolled 30 healthy male volunteers in Germany. It is completed with no active trials ongoing.