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Completed

NCT Number: NCT02532673

Impact of Hyperbilirubinemia Among HIV Patients Treated With Atazanavir

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Atazanavir persistence among treated patients who develop hyperbilirubinemia compared with Atazanavir-treated patients without evidence of hyperbilirubinemia

    Time frame: One year after starting Atazanavir

    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

  2. Atazanavir compliance among treated patients who develop hyperbilirubinemia compared with Atazanavir-treated patients without evidence of hyperbilirubinemia

    Time frame: One year after starting Atazanavir

    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

Secondary outcomes

  1. Healthcare costs for HBR vs non-HBR patients

    Time frame: 1 year

    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
  2. Health care resource utilization for HBR vs non-HBR patients

    Time frame: 1 year

    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.

  3. Changes (increase, decrease, no change) in the grade of bilirubin laboratory test results during follow-up among Atazanavir-treated patients who develop hyperbilirubinemia

    Time frame: 1 year

    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

  4. Rate of Human immunodeficiency virus viral suppression among patients treated with Atazanavir who develop hyperbilirubinemia compared with patients without evidence of hyperbilirubinemia

    Time frame: 1 year

  5. 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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 26, 2015
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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