HIV InfectionNCT02211807
Suicidality and Suicide Attempt Among HIV Patients on Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens
An observational study of HIV Infection, run by Bristol-Myers Squibb.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- HIV Infection
- How many people
- 11,400 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in a commercial insurance database and a Medicaid database
Who may be able to join
- At least 6 months of enrollment before first prescription
- Antiretroviral naive
Who cannot join
- No diagnosis of HIV on patient record
- Age < 12 years
About this study
Official title: The Risk of Suicidality and Suicide Attempt Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens
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.
- Conditions
- HIV Infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients initiating an Efavirenz | Patients initiating an Efavirenz-containing antiretroviral regimen | |
| Patients initiating an Efavirenz-free regimen | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of Suicidality, defined as suicidal ideation and suicide attempt
Measured: 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 outcomes (2)
Number of suicide attempt cases, defined as an inpatient or emergency room claim with at least one ICD-9-CM code for suicide attempt
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Truven Health Analytics
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211807
- Sponsor's protocol ID
- AI266-960
- Status last verified
- Oct 2014
- First submitted
- 21 Jul 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of Suicidality and Suicide Attempt Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens
- ClinicalTrials.gov ID
- NCT02211807
- Acronym / sponsor ID
- AI266-960
- Conditions
- HIV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,400 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Truven Health Analytics
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients initiating an Efavirenz | – | –Patients initiating an Efavirenz-containing antiretroviral regimen |
| Patients initiating an Efavirenz-free regimen | – | – |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in a commercial insurance database and a Medicaid database
Key inclusion criteria (2 listed)
- At least 6 months of enrollment before first prescription
- Antiretroviral naive
Key exclusion criteria (2 listed)
- No diagnosis of HIV on patient record
- Age < 12 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of cases of Suicidality, defined as suicidal ideation and suicide attempt
Time frame: 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
2 secondary outcomes
Number of suicide attempt cases, defined as an inpatient or emergency room claim with at least one ICD-9-CM code for suicide attempt
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by Bristol-Myers Squibb.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases of Suicidality, defined as suicidal ideation and suicide attempt (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.