Status:
COMPLETED
Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication
Lead Sponsor:
Technical University of Munich
Collaborating Sponsors:
Gilead Sciences
MUC Research GmbH
Conditions:
Insulin Resistance
Eligibility:
MALE
18-40 years
Phase:
PHASE1
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 hyperinsulinemi...
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,...
Eligibility Criteria
Inclusion
- Healthy male volunteers, age 18-40 years
- Informed consent and willingness in study participation
- Birth control during study period
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02203461
Start Date
July 1 2014
End Date
October 1 2014
Last Update
November 5 2014
Active Locations (1)
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1
University Hospital Klinikum rechts der Isar (TUM)
Munich, Bavaria, Germany, 81675