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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • University Hospital Klinikum rechts der Isar (TUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat	Drug: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat; STRIBILD® QD, d1-14; Other Names: STRIBILD®
Active Comparator: Group II; Truvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir	Drug: Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir; Truvada®/ Kaletra® 200/50 mg QD, d1-14; Other Names: Truvada® / Kaletra®
Experimental: Group III; Truvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir	Drug: Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir; Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14; Other Names: Truvada®/Prezista®/Norvir®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp	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.	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in metabolic parameters	Changes in lipid, metabolic hormons and "HOMA-IR", "Homa-beta", "QUICKIE" test.	Day 14

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Gilead Sciences; MUC Research GmbH
• Investigators: Principal Investigator: Christoph D Spinner, MD, University Hospital Klinikum rechts der Isar, Technische Universitaet Muenchen

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Estimate): November 5, 2014
• Last Update Submitted That Met QC Criteria: November 4, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: ART, HIV, insulin resistance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Integrase Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Tenofovir; Emtricitabine; Cobicistat; Ritonavir; Lopinavir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Darunavir; Elvitegravir
• Other Study ID Numbers: STR-1383--0030-I; 2014-000359-98 (EudraCT Number)