Status:
COMPLETED
The Effects of Atazanavir-induced Hyperbilirubinemia During Human Endotoxemia
Lead Sponsor:
Radboud University Medical Center
Conditions:
Endotoxemia
Inflammation
Eligibility:
MALE
18-35 years
Phase:
NA
Brief Summary
Excessive inflammation, production of free radicals and vascular injury are considered the main contributors to the development of organ dysfunction in patients with severe infections and sepsis. The ...
Eligibility Criteria
Inclusion
- Healthy male volunteers
Exclusion
- Use of any medication or anti-oxidant vitamin supplements.
- History of allergic reaction to atazanavir.
- Smoking.
- Previous spontaneous vagal collapse.
- History, signs or symptoms of cardiovascular disease.
- (Family) history of myocardial infarction or stroke under the age of 65 years.
- Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block.
- Hypertension (defined as RR systolic \> 160 or RR diastolic \> 90).
- Hypotension (defined as RR systolic \< 100 or RR diastolic \< 50).
- Renal impairment (defined as plasma creatinin \>120 μmol/l).
- Liver enzyme abnormalities or positive hepatitis serology.
- Subjects with a total bilirubin level above 15 μmol/L and a normal direct bilirubin level suggesting Gilbert Syndrome.
- Positive HIV serology or any other obvious disease associated with immune deficiency.
- Febrile illness in the week before the LPS challenge.
- Participation in a drug trial or donation of blood 3 months prior to the LPS challenge.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00916448
Start Date
May 1 2009
End Date
July 1 2015
Last Update
August 14 2015
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB