HIV/AIDSNCT02426866
Risk of CV Events With EFV vs. EFV-free Regimens
An observational study of HIV/AIDS, run by Bristol-Myers Squibb.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Efavirenz
- How many people
- 29,612 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jan 2015
- 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 18 years and older
- No healthy volunteers
- Adult, Older adult
Study population: Commercial insurance database and Medicaid database
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Risk of Cardiovascular Events Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens
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.
- Conditions
- HIV/AIDS
- Being tested
- Efavirenz
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfavirenzDrug
| Study group | Role | What they receive |
|---|---|---|
| Patient with Efavirenz exposure | Patient with Efavirenz exposure Receives: Drug: Efavirenz | |
| Patient without Efavirenz exposure | Patient without Efavirenz exposure Receives: Drug: Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: upto 1 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startDec 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies 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
- 29,612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Truven health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426866
- Sponsor's protocol ID
- AI266-414
- Status last verified
- Apr 2015
- First submitted
- 22 Apr 2015
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of Cardiovascular Events Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens
- ClinicalTrials.gov ID
- NCT02426866
- Acronym / sponsor ID
- AI266-414
- Conditions
- HIV/AIDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29,612 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Truven health
- Study start
- Dec 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 27 Apr 2015 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with Efavirenz exposure | – | Drug: EfavirenzPatient with Efavirenz exposure |
| Patient without Efavirenz exposure | – | Drug: EfavirenzPatient without Efavirenz exposure |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Commercial insurance database and Medicaid database
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efavirenz | Drug | Patient with Efavirenz exposure, Patient without Efavirenz exposure |
Primary outcome
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
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 27 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, 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 4 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 27 Apr 2015. 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?
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). 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 27 Apr 2015.