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
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring ART, HIV, insulin resistance
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
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
NCT ID
NCT02203461
First Posted
July 28, 2014
Last Updated
November 4, 2014
Sponsor
Technical University of Munich
Collaborators
Gilead Sciences, MUC Research GmbH
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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