The effects of atazanavir-induced hyperbilirubinemia during human endotoxemia.

The effects of atazanavir-induced hyperbilirubinemia during human endotoxemia. - Atazanavir-induced hyperbilirubinemia during human endotoxemia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33311

Enrollment

Registered

2009-03-13

Start date

2009-05-11

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood poisoning sepsis

Interventions

Subjects will receive atazanavir (four day treatment with 300 mg twice daily n=10) or placebo (n=10). Pre-hydration will be performed by infusion of 1.5 L 2.5% glucose/0.45% saline solution in 1 hou

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age >= 18 and

Exclusion criteria

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 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

Design outcomes

Secondary

Measure	Time frame
Secondary study parameters include: - Endothelial function after LPS administration in the absence or presence of atazanavir-induced hyperbilirubinemia - Gastric perfusion after LPS administration in the absence or presence of atazanavir-induced hyperbilirubinemia - Subclinical renal impairment after LPS administration in the absence or presence of atazanavir-induced hyperbilirubinemia - HO-1 activity after LPS administration in the absence or presence of atazanavir-induced hyperbilirubinemia	—

Measure

Time frame

Secondary study parameters include: - Endothelial function after LPS administration in the absence or presence of atazanavir-induced hyperbilirubinemia - Gastric perfusion after LPS administration in the absence or presence of atazanavir-induced hyperbilirubinemia - Subclinical renal impairment after LPS administration in the absence or presence of atazanavir-induced hyperbilirubinemia - HO-1 activity after LPS administration in the absence or presence of atazanavir-induced hyperbilirubinemia

—

Primary

Measure	Time frame
The main study parameter is the concentration of circulating cytokines after LPS in the absence or presence of atazanavir-induced hyperbilirubinemia.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)