Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Technische Universität München
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: NA
Last verified: July 2014
History: No changes posted
  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
Healthy Volunteers
Drug: STRIBILD®
Drug: Truvada® / Kaletra®
Drug: Truvada®/Prezista®/Norvir®
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.


Estimated Enrollment: 30
Study Start Date: July 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group I
STRIBILD®
Drug: STRIBILD®
STRIBILD® Medication, oral, once-daily from day 1-14 in the evening
Active Comparator: Group II
Truvada®/Kaletra®
Drug: Truvada® / Kaletra®
Truvada® / Kaletra® 200/50 mg Medication, oral, once-daily from day 1-14 in the evening
Active Comparator: Group III
Truvada®/Prezista®/Norvir®
Drug: Truvada®/Prezista®/Norvir®
Truvada®/Prezista® 800 mg /Norvir®100 mg Medication, oral, once-daily from day 1-14 in the evening

  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 willigness to 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, Hypertriglycideremia 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

Contacts
Contact: Christoph D. Spinner, MD +49 (89) 4140 ext 2251 christoph.spinner@lrz.tum.de
Contact: Roman Iakoubov, MD +49 (89) 4140 ext 2251 Roman.Iakoubov@lrz.tu-muenchen.de

Locations
Germany
University Hospital Klinikum rechts der Isar (TUM) Recruiting
Munich, Bavaria, Germany, 81675
Contact: Christoph D Spinner, MD    +49 (89) 4140 ext 2251    christoph.spinner@lrz.tum.de   
Principal Investigator: Christoph D Spinner, MD         
Sub-Investigator: Roman Iakobouv, MD         
Sponsors and Collaborators
Technische Universität München
Gilead Sciences
MUC Research GmbH
  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: July 28, 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
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014