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Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat
Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir
Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring ART, HIV, insulin resistance

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts 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

Sites / Locations

  • University Hospital Klinikum rechts der Isar (TUM)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Group I

Group II

Group III

Arm Description

STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in metabolic parameters
Changes in lipid, metabolic hormons and "HOMA-IR", "Homa-beta", "QUICKIE" test.

Full Information

First Posted
July 28, 2014
Last Updated
November 4, 2014
Sponsor
Technical University of Munich
Collaborators
Gilead Sciences, MUC Research GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02203461
Brief Title
Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication
Official Title
Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
Collaborators
Gilead Sciences, MUC Research GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
ART, HIV, insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Truvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir
Arm Title
Group III
Arm Type
Experimental
Arm Description
Truvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
Intervention Type
Drug
Intervention Name(s)
Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat
Other Intervention Name(s)
STRIBILD®
Intervention Description
STRIBILD® QD, d1-14
Intervention Type
Drug
Intervention Name(s)
Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir
Other Intervention Name(s)
Truvada® / Kaletra®
Intervention Description
Truvada®/ Kaletra® 200/50 mg QD, d1-14
Intervention Type
Drug
Intervention Name(s)
Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
Other Intervention Name(s)
Truvada®/Prezista®/Norvir®
Intervention Description
Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14
Primary Outcome Measure Information:
Title
Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp
Description
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.
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Changes in metabolic parameters
Description
Changes in lipid, metabolic hormons and "HOMA-IR", "Homa-beta", "QUICKIE" test.
Time Frame
Day 14

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph D Spinner, MD
Organizational Affiliation
University Hospital Klinikum rechts der Isar, Technische Universitaet Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Klinikum rechts der Isar (TUM)
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

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Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

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