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

The Risk of Suicidality and Suicide Attempt Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02211807

Enrollment

11400

Registered

2014-08-08

Start date

2014-04-30

Completion date

2014-08-31

Last updated

2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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

Outcome results