NCT02532673

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

9 months

First QC Date

August 11, 2015

Last Update Submit

August 23, 2015

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (5)

  • Healthcare costs for HBR vs non-HBR patients

    1 year

  • Health care resource utilization for HBR vs non-HBR patients

    1 year

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

    1 year

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

    1 year

  • 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

Study Arms (2)

Hyperbilirubinemia Cohort

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

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Commercially insured population (single large health plan)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

August 26, 2015

Study Start

August 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 26, 2015

Record last verified: 2015-08