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NCT02426866 Clinical Trial

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

HIV/AIDS Clinical Trial

Official title:
The Risk of Cardiovascular Events Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02426866
Other study ID # AI266-414
Secondary ID
Status Completed
Phase N/A
First received April 22, 2015
Last updated April 22, 2015
Start date December 2014
Est. completion date January 2015

Study information
Verified date April 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 29612
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Efavirenz

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb Truven health

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
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