Risk of CV Events With EFV vs. EFV-free Regimens

Completed

• Conditions: HIV/AIDS
• Interventions: Drug: Efavirenz

• Registration Number: NCT02426866
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-04
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-04-22
• Last Update Submitted: 2015-04-22
• Study First Posted: 2015-04-27
• Last Update Posted: 2015-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 29612

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient without Efavirenz exposure	Efavirenz	Patient without Efavirenz exposure
Patient with Efavirenz exposure	Efavirenz	Patient with Efavirenz exposure

Primary Outcome Measures

Name	Time	Method
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	upto 1 to 5 years	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