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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29612 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV/AIDS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient with Efavirenz exposure

Efavirenz

Intervention Type DRUG

Patient without Efavirenz exposure

Efavirenz

Intervention Type DRUG

Interventions

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Efavirenz

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

Accepts Healthy Volunteers

No