Impact of Hyperbilirubinemia Among HIV Patients Treated With Atazanavir

HIV/AIDS Clinical Trial

Official title:

Impact of Hyperbilirubinemia Among HIV Patients Treated With Atazanavir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532673
• Other study ID #: AI424-531
• Status: Completed
• Phase: N/A
• First received: August 11, 2015
• Last updated: August 23, 2015
• Start date: August 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Human immunodeficiency virus

• Treatment with Atazanavir

• 18 yrs and older

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV/AIDS
• Hyperbilirubinemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atazanavir persistence among treated patients who develop hyperbilirubinemia compared with Atazanavir-treated patients without evidence of hyperbilirubinemia	Discontinuation rate, defined as proportion of patients having discontinued Atazanavir at 1 year, of HBR vs. non-HBR patients. Persistence, defined as mean days to Atazanavir discontinuation, of HBR vs non-HBR patients. Compliance defined as mean medication-possession ratio of HBR vs non-HBR patients	One year after starting Atazanavir	Yes
Primary	Atazanavir compliance among treated patients who develop hyperbilirubinemia compared with Atazanavir-treated patients without evidence of hyperbilirubinemia	Discontinuation rate, defined as proportion of patients having discontinued Atazanavir at 1 year, of HBR vs. non-HBR patients. Persistence, defined as mean days to Atazanavir discontinuation, of HBR vs non-HBR patients. Compliance defined as mean medication-possession ratio of HBR vs non-HBR patients	One year after starting Atazanavir	Yes
Secondary	Healthcare costs for HBR vs non-HBR patients	Health care costs: Health care costs will be computed as the combined health plan and patient paid amounts for all claims in the 12-month post-index period. Mean costs will be calculated for total costs, medical costs, pharmacy costs, ambulatory costs, emergency services costs, inpatient costs, and other costs.; Costs will be adjusted into 2013 US dollars using the annual medical care component of the Consumer Price Index (CPI) to reflect inflation between 2003 and 2013	1 year	No
Secondary	Health care resource utilization for HBR vs non-HBR patients	Health care resource utilization: Binary indicators and counts of mean number of ambulatory visits (office and outpatient), ER visits, and inpatient admissions over 12 months will be calculated. Total number of inpatient days and mean length of inpatient stay will also will be captured.	1 year	No
Secondary	Changes (increase, decrease, no change) in the grade of bilirubin laboratory test results during follow-up among Atazanavir-treated patients who develop hyperbilirubinemia	Grade of the bilirubin test result will be captured and defined as follows: Grade 0 = normal; Grade 1 = 1.0 to 1.5 times the upper limit of normal (x ULN), Grade 2 =1.5 to 2.5 x ULN; Grade 3 = 2.5 to 5 x ULN; Grade 4 = 5 x ULN; The upper limit of normal range was used to standardize the laboratory results across different lab systems. Each laboratory vendor provides a normal range for their results. These results were then transformed based on the normal ranges provided. The ranges below were used to categorize the patients: =0, if result in normal rage; =1, if result > 1.0-1.5 times the upper limit of normal (x ULN); =2, if result > 1.5-2.5 x ULN; =3, if result > 2.5-5 x ULN; =4, if result > 5 x ULN	1 year	Yes
Secondary	Rate of Human immunodeficiency virus viral suppression among patients treated with Atazanavir who develop hyperbilirubinemia compared with patients without evidence of hyperbilirubinemia		1 year	Yes
Secondary	Liver function based on Alanine aminotransferase and Aspartate aminotransferase test results among patients treated with Atazanavir who develop hyperbilirubinemia compared with patients without evidence of hyperbilirubinemia		1 year	Yes

External Links

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