Impact of Hyperbilirubinemia Among HIV Patients Treated With Atazanavir

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: HIV/AIDS

Study type: Observational

Funder types: Industry

Identifiers

NCT02532673

AI424-531

Details and patient eligibility

About

The purpose of this study is to determine whether HIV patients on Atazanavir who have Hyperbilirubinemia have different outcomes from those without Hyperbilirubinemia.

Enrollment: 1,200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of Human immunodeficiency virus
• Treatment with Atazanavir
• 18 yrs and older

Trial design

1,200 participants in 2 patient groups

Hyperbilirubinemia Cohort

Description:

Patients will be included who have evidence of hyperbilirubinemia (laboratory test of grade 2 or greater or \> 2 medical claims with an International Classification of Diseases, Ninth Revision, Clinical Modification code of 782.4 or 277.4 in any position) in the first 90 days after initiating Atazanavir therapy.

Non-hyperbilirubinemia cohort

Description:

Patients will be included who have no evidence of hyperbilirubinemia (no laboratory test of grade 2 or greater or any medical claims with an International Classification of Diseases, Ninth Revision, Clinical Modification of 782.4 or 277.4 in any position) in the 12-month follow-up period.