Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study.

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).

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