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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: HIV/AIDS

Treatments: Drug: Efavirenz

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02426866

AI266-414

Details and patient eligibility

About

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.

Enrollment: 29,612 patients

Sex

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

29,612 participants in 2 patient groups

Patient with Efavirenz exposure

Description:

Patient with Efavirenz exposure

Treatment:

Drug: Efavirenz

Patient without Efavirenz exposure

Description:

Patient without Efavirenz exposure

Treatment:

Drug: Efavirenz