CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
Atazanavirdrug
Likely dose
Atazanavir 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01421355
NCT01421355Phase 1Completed
CompareCT.gov

A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus

Brigham and Women's Hospital·interventional·Posted Aug 22, 2011·Updated Jul 21, 2014

In Brief

A Phase 1 clinical trial evaluating Atazanavir for Type 1 Diabetes Mellitus. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Specific Aim: To establish the feasibility of studying the change in endothelial function caused by induced moderate hyperbilirubinemia in type 1 diabetes. Atazanavir, a drug that inhibits bilirubin conjugation, will be used to induce moderate hyperbilirubinemia. Endothelial function will be measured before and after atazanavir therapy. In addition, plasma markers of antioxidant capacity and oxidant stress will be measured as proof-of-concept that induced moderate hyperbilirubinemia has favorable effects on oxidative stress in type 1 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH)

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 22, 2011
Enrollment StartMay 1, 2012
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.9 years ago

Interventions

Atazanavirdrug

The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug.