Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

Technical University of Munich

Status and phase: Completed; Phase 1

Conditions: Insulin Resistance

Treatments: Drug: Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir; Drug: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat; Drug: Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02203461

2014-000359-98 (EudraCT Number)

STR-1383--0030-I

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 30 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Group I

Experimental group

Description:

STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat

Treatment:

Drug: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat

Group II

Active Comparator group

Description:

Truvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir

Treatment:

Drug: Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir

Group III

Experimental group

Description:

Truvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir

Treatment:

Drug: Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir