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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02532673
Other study ID # AI424-531
Secondary ID
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


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
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