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

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ClinicalTrials.gov Identifier: NCT02426866
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : April 27, 2015
Sponsor:
Collaborator:
Truven health
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
HIV/AIDS Drug: Efavirenz

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Study Type : Observational
Actual Enrollment : 29612 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Risk of Cardiovascular Events Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens
Study Start Date : December 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Efavirenz

Group/Cohort Intervention/treatment
Patient with Efavirenz exposure
Patient with Efavirenz exposure
Drug: Efavirenz
Patient without Efavirenz exposure
Patient without Efavirenz exposure
Drug: Efavirenz



Primary Outcome Measures :
  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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Commercial insurance database and Medicaid database
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
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02426866    
Other Study ID Numbers: AI266-414
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: April 27, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers