Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 28, 2014
CompletedFirst Posted
Study publicly available on registry
July 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedNovember 5, 2014
November 1, 2014
3 months
July 28, 2014
November 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Changes in metabolic parameters
Day 14
Study Arms (3)
Group I
EXPERIMENTALSTRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat
Group II
ACTIVE COMPARATORTruvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir
Group III
EXPERIMENTALTruvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
Interventions
STRIBILD® QD, d1-14
Truvada®/ Kaletra® 200/50 mg QD, d1-14
Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14
Eligibility Criteria
You may qualify if:
- Healthy male volunteers, age 18-40 years
- Informed consent and willingness in study participation
- Birth control during study period
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Technical University of Munichlead
- Gilead Sciencescollaborator
- MUC Research GmbHcollaborator
Study Sites (1)
University Hospital Klinikum rechts der Isar (TUM)
Munich, Bavaria, 81675, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph D Spinner, MD
University Hospital Klinikum rechts der Isar, Technische Universitaet Muenchen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2014
First Posted
July 30, 2014
Study Start
July 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
November 5, 2014
Record last verified: 2014-11