Risk of CV Events With EFV vs. EFV-free Regimens
The Risk of Cardiovascular Events Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens
1 other identifier
observational
29,612
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether there is an increased risk of cardiovascular events (CV) with regimens containing efavirenz (EFV) versus other regimens in patients with HIV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2014
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 22, 2015
CompletedFirst Posted
Study publicly available on registry
April 27, 2015
CompletedApril 27, 2015
April 1, 2015
1 month
April 22, 2015
April 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Cardiovascular events specifically based on incidence rate and compare the hazard between the HIV infected patient initiating efavirenz-containing antiretroviral regimen and efavirenz-free antiretroviral regimen
cardiovascular events specifically based on incidence rate and compare the hazard (myocardial infarction, stroke,percutaneous coronary intervention, coronary artery bypass graft, and composite of aforementioned events) between the HIV infected patient initiating efavirenz-containing antiretroviral regimen and efavirenz-free antiretroviral regimen
upto 1 to 5 years
Study Arms (2)
Patient with Efavirenz exposure
Patient with Efavirenz exposure
Patient without Efavirenz exposure
Patient without Efavirenz exposure
Interventions
Eligibility Criteria
Commercial insurance database and Medicaid database
You may qualify if:
- Aged 18 years or older on the index date
- Have at least one pharmacy claim for efavirenz or a drug in the comparison cohort during the period spanning January 1, 2007 through December 31,2013.
- Clinical Modification (ICD-9) diagnosis code for HIV infection including 042 (HIV disease), V08 (asymptomatic HIV infection status), 795.71 (nonspecific serologic evidence of HIV), and 079.53 (HIV, type 2) any time prior to the index claim.
- Have at least 6 months (180 days) of continuous enrollment prior to the index claim
You may not qualify if:
- Patients who have been dispensed any antiretroviral medications anytime before the index date including the 180-day baseline period
- Patients with evidence of a cardiovascular outcome of interest during the 180-day baseline period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Truven healthcollaborator
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2015
First Posted
April 27, 2015
Study Start
December 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
April 27, 2015
Record last verified: 2015-04