Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Technische Universität München
• Collaborators: Gilead Sciences; MUC Research GmbH
• Treatments: Cobicistat; Darunavir; Elvitegravir; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Insulin; Lopinavir; Ritonavir; Tenofovir

Criteria

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 disease incl. Diabetes mellitus, Hypertriglyceridemia or others

• Known alcohol or nicotine abuse

• HIV infection

• History of pharmaceutical study in the last 4 weeks

• BMI < 18 > 25

• Long-term or regular medication

• Known liver-, renal-, cardiovascular, lung, gastrointestinal, endocrine, neurologic, psychiatric or metabolic disorder

• Dependence to study center or coordinator

• Inmates or psychiatric treatment