The effects of atazanavir-induced hyperbilirubinemia during human endotoxemia.

Completed

Conditions: Blood poisoning
sepsis
10004018
10011954

Registration Number: NL-OMON33311

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Age >= 18 and <= 35 yrs
Male
Healthy

Exclusion Criteria

- 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 mmHg)
- 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 umol/l suggesting Gilbert Syndrome.
- Positive HIV serology
- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the concentration of circulating cytokines after<br /><br>LPS in the absence or presence of atazanavir-induced hyperbilirubinemia. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters include:<br /><br>- Endothelial function after LPS administration in the absence or presence of<br /><br>atazanavir-induced hyperbilirubinemia<br /><br>- Gastric perfusion after LPS administration in the absence or presence of<br /><br>atazanavir-induced hyperbilirubinemia<br /><br>- Subclinical renal impairment after LPS administration in the absence or<br /><br>presence of atazanavir-induced hyperbilirubinemia<br /><br>- HO-1 activity after LPS administration in the absence or presence of<br /><br>atazanavir-induced hyperbilirubinemia</p><br>