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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02426866

Enrollment

29612

Registered

2015-04-27

Start date

2014-12-31

Completion date

2015-01-31

Last updated

2015-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

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.

Interventions

DRUGEfavirenz

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026