Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

Phase 1

Completed

• Conditions: Insulin Resistance
• Interventions: Drug: Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir; Drug: Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir; Drug: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat

• Registration Number: NCT02203461
• Lead Sponsor: Technical University of Munich

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-30
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-04
• Last Update Posted: 2014-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group III	Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir	Truvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
Group II	Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir	Truvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir
Group I	Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat	STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat

Primary Outcome Measures

Name	Time	Method
Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp	Day 14	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.

Secondary Outcome Measures

Name	Time	Method
Changes in metabolic parameters	Day 14	Changes in lipid, metabolic hormons and "HOMA-IR", "Homa-beta", "QUICKIE" test.

Trial Locations

Locations (1)

University Hospital Klinikum rechts der Isar (TUM); 🇩🇪 Munich, Bavaria, Germany