Hyperbilirubinemia, the favourable side effect of atazanavir? Influence of atazanavir treatment on endothelial dysfunction, vascular inflammation and heme oxygenase activity in type 2 diabetes mellitus. - Hyperbilirubinemia, the favourable side effect of atazanavir?

• Conditions: Type 2 diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10053246Term: Type II diabetes peripheral angiopathy

• Registration Number: EUCTR2008-000771-17-NL
• Lead Sponsor: RUNMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- At least 18 and not older than 65 years of age on the day of the first dosing.
- Type 2 diabetes mellitus treated with diet, oral medication and/or insulin.
- Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- History of smoking within the past year
- History of or current abuse of drugs, alcohol or solvents.
- Current use of antihypertensive, cardiac or other vasoactive medication.
- Current use of acetylsalicylic acid
- Use of antioxidant vitamin supplements
- Use of acid suppressive medication
- Inability to suspend the use of statins during trial participation
- Clinical evidence of cardiac or pulmonary disease
- Laboratory evidence of renal or hepatic abnormalities, defined as results exceeding twice the upper limit of normal range.
- Cardiac conduction abnormalities, consisting of a 2nd degree atrioventricular block or a complex bundle branch block.
- Subjects with Gilbert Syndrome, which is suggested by an unconjucated hyperbilirubinemia (total bilirubin level above 10 µmol/L and a normal direct bilirubin level) and has to be confirmed by genetic testing.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified