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Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

This study has been completed.
Sponsor:
Collaborators:
Gilead Sciences
MUC Research GmbH
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT02203461
First received: July 28, 2014
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Insulin Resistance
Drug: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat
Drug: Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir
Drug: Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study.

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
    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:
  • Changes in metabolic parameters [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Changes in lipid, metabolic hormons and "HOMA-IR", "Homa-beta", "QUICKIE" test.


Enrollment: 30
Study Start Date: July 2014
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I
STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat
Drug: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat
STRIBILD® QD, d1-14
Other Name: 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 Name: 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 Name: Truvada®/Prezista®/Norvir®

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).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02203461

Locations
Germany
University Hospital Klinikum rechts der Isar (TUM)
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Gilead Sciences
MUC Research GmbH
Investigators
Principal Investigator: Christoph D Spinner, MD University Hospital Klinikum rechts der Isar, Technische Universitaet Muenchen
  More Information

Additional Information:
No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02203461     History of Changes
Other Study ID Numbers: STR-1383--0030-I, 2014-000359-98
Study First Received: July 28, 2014
Last Updated: November 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:
ART, HIV, insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Darunavir
Emtricitabine
Insulin
Lopinavir
Ritonavir
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014