Suicidality and Suicide Attempt Among HIV Patients on Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens

Completed

• Conditions: HIV Infection

• Registration Number: NCT02211807
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study was to compare the frequency of suicidality and suicide attempt among HIV patients starting treatment with Efavirenz and with patients starting treatment with other HIV medications.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-07-21
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted QC: 2014-08-07
• Study First Posted: 2014-08-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11400

Inclusion Criteria

• At least 6 months of enrollment before first prescription
• Antiretroviral naive

Exclusion Criteria

• No diagnosis of HIV on patient record
• Age < 12 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of cases of Suicidality, defined as suicidal ideation and suicide attempt	Patients will be followed from date of index fill of efavirenz or comparator antiretrovirals until earliest of date of suicidality claim,30th day after the last day of the days supply of the index medication,last day of enrollment or end of study period

Secondary Outcome Measures

Name	Time	Method
Number of suicide attempt cases, defined as an inpatient or emergency room claim with at least one ICD-9-CM code for suicide attempt	Patients will be followed from date of index fill of efavirenz or comparator antiretrovirals until earliest of date of suicidality claim,30th day after the last day of the days supply of the index medication,last day of enrollment or end of study period
Number of suicide attempt cases	Patients will be followed from date of index fill of efavirenz or comparator antiretrovirals until earliest of date of suicidality claim,30th day after the last day of the days supply of the index medication,last day of enrollment or end of study period	Expanded definition, defined as an inpatient of emergency department claim for suicidal attempt or a claim for toxic effects of poisoning, open wound to elbow, wrist or forearm, of asphyxiation plus a diagnosis of psychiatric disorders