HIV InfectionNCT01054638
HIV Treatment and CVD Events
An observational study of HIV Infection and Cardiovascular Disease, run by ViiV Healthcare.
Trial summary
Cardiovascular disease (CVD) has been associated with HIV infection. However, it is uncertain whether increased CVD rates are associated with HIV-related factors (e.g., HIV-infection or highly active antiretroviral therapy (HAART) may worsen dyslipidemia) or reflect differences in the prevalence of underlying risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Cardiovascular Disease, Infection, Human Immunodeficiency Virus
- What is being tested?
- HAART Treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Dec 2010
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Source population is from the proprietary Ingenix NHI Database, a large, geographically diverse population of U.S. health insurance plan enrollees. Records are organized into a medical file containing claims from providers and facilities, a pharmacy file with outpatient pharmacy dispensing records, and an enrollment file that provides demographic data and dates of insurance eligibility for persons in the database. Laboratory test results are also available for a fraction of the population. In addition, i3 Drug Safety will complement the data from the NHI Database with data from the Ingenix National Managed Care (Impact) Database, a fully de-identified, HIPAA compliant database from health insurance claims and enrollment data of more than 30 health plans separate from the plan affiliated with the NHI Database. Patients in each data source have a common unique identifier; therefore, it is possible to construct a combined population without concern that some patients may be duplicated.
Who may be able to join
- All patients aged 18 years or older with an initial claims diagnosis of HIV infection associated with a physician visit occurring after at least 6 months (183 days) of continuous enrollment between 01 January 1998 and 31 December 2007 will be included in the primary cohort. Patients will be required to have commercial health insurance coverage and complete medical and pharmacy benefits. The cohort entry date for each patient will be limited to the first claim associated with a HIV infection diagnosis that meets the 6-month continuous enrollment criteria. Patients with a HIV infection diagnosis claim who do not have at least one continuously enrolled segment that is equal to or greater than 6 months prior to the cohort entry date will be excluded. Six months of continuous enrollment prior to the initial claim associated with a HIV infection diagnosis will be required to guarantee the availability of a 6-month baseline period for ascertaining exposure to HAART prior to cohort entry and covariates of interest for the Poisson regression models. Patients may enter the primary cohort already exposed to HAART and with a HIV infection diagnosis claim in the 6-month baseline period.
Who cannot join
- -
About this study
Official title: HIV Treatment and CVD Events - Ingenix. Retrospective Database Analysis of Patients With Human Immunodeficiency Virus (HIV) Treatment and Cardiovascular Disease (CVD) Events
Cardiovascular disease (CVD) has been associated with HIV infection. However, it is uncertain whether increased CVD rates are associated with HIV-related factors (e.g., HIV-infection or highly active antiretroviral therapy (HAART) may worsen dyslipidemia) or reflect differences in the prevalence of underlying risk factors for CVD. Furthermore, the association between initiation and duration of HAART exposure and CVD risk, including which specific drugs within the HAART classes may contribute to the increased risk, is unknown. The primary objectives of the study are therefore:
- To estimate the absolute and relative incidence rate (IR) of CVD claims-based diagnoses among a cohort of adult patients from a large managed care population with a claims diagnosis of HIV, AIDS, or AIDS-related complex (ARC) during periods of exposure to:
- Any HAART compared to no HAART exposure
- HAART class [i.e., NRTIs, NNRTIs, PIs, and Other (i.e., fusion inhibitors)] compared to no HAART class exposure
- Specific NRTI medications compared to no specific NRTI exposure
Read the detailed description
The scientific approach is to conduct a retrospective cohort study of patients with a claims diagnosis of HIV, AIDS, or ARC (simply referred to as HIV infection) among commercially insured people in the U.S. to estimate the IR of acute MI (AMI), AMI including coronary revascularization (CR) procedures, and CVD, comparing exposure to HAART treatments. We will identify a primary cohort of patients with an initial claims diagnosis of HIV infection occurring after at least 6 months of continuous enrollment in the Ingenix National Health Informatics (NHI) or Ingenix Impact National Managed Care (Impact) Databases between 01 January 1998 and 31 December 2007. For each eligible primary cohort member, we will identify all HAART dispensings during the baseline and follow-up periods and categorize person-time of exposure by any HAART, HAART class, and specific NRTI medications. We will also specifically evaluate the risk associated with fosamprenavir and amprenavir use. Study outcome events, including AMI, AMI including CR procedures, and CVD, will be identified from the medical claims data for all patients during the follow-up period.
For the primary analysis, we will estimate the absolute IR and 95% confidence intervals (CIs) of each study outcome event during periods of recent, past, non-use, and cumulative duration (non-use, < 1 year, 1 - 2 years, and > 2 years) of each HAART exposure classification. We will also estimate the rate difference (RD) and 95% CI of each study outcome event during periods of recent, past, and cumulative duration (< 1 year, 1 - 2 years, and > 2 years) of each HAART exposure classification relative to non-use. We will use Poisson regression models to estimate the multivariable adjusted rate ratio (RR) and 95% CIs of each study outcome event during periods of recent, past, and cumulative duration (non-use, < 1 year, 1 - 2 years, and > 2 years) of HAART use relative to non-use for each HAART exposure classification, adjusting for confounding variables derived from the claims history of each person during their 6-month baseline period to account for channeling bias and during the follow-up period to account for changing risk factors for CVD. To further account for confounding of indication by abacavir use, analyses will be stratified by calendar year 2004, during which time there was a significant change in the primary indication for abacavir use in HIV. Analyses will be repeated as a secondary analysis on the subgroup of patients in the NHI Database with any outpatient laboratory test result; these analyses will account for values of cholesterol, cluster of differentiation 4 (CD4) count, and viral load [HIV-1 ribonucleic acid (RNA)] laboratory tests.
Among the primary cohort, we will identify a subcohort of patients with an initial claims diagnosis of HIV infection occurring after at least 6 months of continuous enrollment and without HAART medication in the 6-month baseline period prior to the cohort entry date. We will repeat the primary and secondary analyses among this naïve subcohort of HAART initiators.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
- Conditions
- HIV Infection, Cardiovascular Disease, Infection, Human Immunodeficiency Virus, Acute Myocardial Infarction
- Being tested
- HAART Treatment
- Keywords
- amprenavir, fosamprenavir, HIV, HAART treatment, Epzicom, Trizivir, Combivir, zidovudine, lamivudine, cardiovascular disease, HIV Infections
- Medical subject headings
- HIV Infections, Cardiovascular Diseases, Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAART TreatmentDrug
Using pharmacy records, identify all patients with HAART dispensing during baseline \& follow-up periods. For combination medications, classify person-time according to individual therapeutic components. HAART exposure classification by 1)any HAART exposure, 2)by HAART class, and 3)by specific nucleoside reverse transcriptase inhibitor exposure. Specific evaluation of fosamprenavir and amprenavir.
Subdivide person-time according to recent, past \& non-use of HAART. Person-time for each patient partitioned into exposure windows of Recent use(From start of dispensing to end of days supplied plus 6 months), Past use(From end of current use to end of follow-up or new HAART dispensing following recent use), \& Non-use(Time prior to first dispensing or all time for those who did not receive a dispensing).
Determine cumulative duration of exposure based on days supplied per dispensing per patient over the baseline \& follow-up periods: Non-use, Less than 1 yr, 1-2 yrs, More than 2yrs.
| Study group | Role | What they receive |
|---|---|---|
| HIV infected patients: HAART naive or experienced | Patients with a claims diagnosis of HIV infection (HIV, AIDS, or ARC) in the NHI or Impact Databases, according to either of the 3-digit International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes 042 HIV disease and V08 Asymptomatic HIV infection status Receives: Drug: HAART Treatment | |
| Patients with HIV infection HAART naïve | A naïve subcohort of patients consisting of HAART initiators. Among the primary cohort, we will exclude patients with a dispensing for any HAART in the 6-month baseline period prior to the cohort entry date. Receives: Drug: HAART Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of acute myocardial infarction, AMI including coronary revascularization (CR) procedures, and cardiovascular disease (MI, other ischemic heart disease, congestive heart failure, peripheral vascular disease, cerebrovascular disease)
Measured: During periods of recent, past, non-use, and cumulative duration (non-use, < 1 year, 1 - 2 years, and > 2 years) of each HAART exposure classification.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionDec 2010
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 ViiV HealthcareThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054638
- Sponsor's protocol ID
- 112872
- Other IDs
- EPI40543, WEUSKOP3283
- Status last verified
- Jul 2011
- First submitted
- 21 Jan 2010
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Treatment and CVD Events - Ingenix. Retrospective Database Analysis of Patients With Human Immunodeficiency Virus (HIV) Treatment and Cardiovascular Disease (CVD) Events
- ClinicalTrials.gov ID
- NCT01054638
- Acronym / sponsor ID
- 112872
- Conditions
- HIV Infection, Cardiovascular Disease, Infection, Human Immunodeficiency Virus, Acute Myocardial Infarction
- Keywords
- amprenavir, fosamprenavir, HIV, HAART treatment, Epzicom, Trizivir, Combivir, zidovudine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Jan 2010 (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.
Cardiovascular disease (CVD) has been associated with HIV infection. However, it is uncertain whether increased CVD rates are associated with HIV-related factors (e.g., HIV-infection or highly active antiretroviral therapy (HAART) may worsen dyslipidemia) or reflect differences in the prevalence of underlying risk factors for CVD. Furthermore, the association between initiation and duration of HAART exposure and CVD risk, including which specific drugs within the HAART classes may contribute to the increased risk, is unknown. The primary objectives of the study are therefore:
- To estimate the absolute and relative incidence rate (IR) of CVD claims-based diagnoses among a cohort of adult patients from a large managed care population with a claims diagnosis of HIV, AIDS, or AIDS-related complex (ARC) during periods of exposure to:
- Any HAART compared to no HAART exposure
- HAART class [i.e., NRTIs, NNRTIs, PIs, and Other (i.e., fusion inhibitors)] compared to no HAART class exposure
- Specific NRTI medications compared to no specific NRTI exposure
Detailed description
The scientific approach is to conduct a retrospective cohort study of patients with a claims diagnosis of HIV, AIDS, or ARC (simply referred to as HIV infection) among commercially insured people in the U.S. to estimate the IR of acute MI (AMI), AMI including coronary revascularization (CR) procedures, and CVD, comparing exposure to HAART treatments. We will identify a primary cohort of patients with an initial claims diagnosis of HIV infection occurring after at least 6 months of continuous enrollment in the Ingenix National Health Informatics (NHI) or Ingenix Impact National Managed Care (Impact) Databases between 01 January 1998 and 31 December 2007. For each eligible primary cohort member, we will identify all HAART dispensings during the baseline and follow-up periods and categorize person-time of exposure by any HAART, HAART class, and specific NRTI medications. We will also specifically evaluate the risk associated with fosamprenavir and amprenavir use. Study outcome events, including AMI, AMI including CR procedures, and CVD, will be identified from the medical claims data for all patients during the follow-up period.
For the primary analysis, we will estimate the absolute IR and 95% confidence intervals (CIs) of each study outcome event during periods of recent, past, non-use, and cumulative duration (non-use, < 1 year, 1 - 2 years, and > 2 years) of each HAART exposure classification. We will also estimate the rate difference (RD) and 95% CI of each study outcome event during periods of recent, past, and cumulative duration (< 1 year, 1 - 2 years, and > 2 years) of each HAART exposure classification relative to non-use. We will use Poisson regression models to estimate the multivariable adjusted rate ratio (RR) and 95% CIs of each study outcome event during periods of recent, past, and cumulative duration (non-use, < 1 year, 1 - 2 years, and > 2 years) of HAART use relative to non-use for each HAART exposure classification, adjusting for confounding variables derived from the claims history of each person during their 6-month baseline period to account for channeling bias and during the follow-up period to account for changing risk factors for CVD. To further account for confounding of indication by abacavir use, analyses will be stratified by calendar year 2004, during which time there was a significant change in the primary indication for abacavir use in HIV. Analyses will be repeated as a secondary analysis on the subgroup of patients in the NHI Database with any outpatient laboratory test result; these analyses will account for values of cholesterol, cluster of differentiation 4 (CD4) count, and viral load [HIV-1 ribonucleic acid (RNA)] laboratory tests.
Among the primary cohort, we will identify a subcohort of patients with an initial claims diagnosis of HIV infection occurring after at least 6 months of continuous enrollment and without HAART medication in the 6-month baseline period prior to the cohort entry date. We will repeat the primary and secondary analyses among this naïve subcohort of HAART initiators.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV infected patients: HAART naive or experienced | – | Drug: HAART TreatmentPatients with a claims diagnosis of HIV infection (HIV, AIDS, or ARC) in the NHI or Impact Databases, according to either of the 3-digit International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes 042 HIV disease and V08 Asymptomatic HIV infection status |
| Patients with HIV infection HAART naïve | – | Drug: HAART TreatmentA naïve subcohort of patients consisting of HAART initiators. Among the primary cohort, we will exclude patients with a dispensing for any HAART in the 6-month baseline period prior to the cohort entry date. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Source population is from the proprietary Ingenix NHI Database, a large, geographically diverse population of U.S. health insurance plan enrollees. Records are organized into a medical file containing claims from providers and facilities, a pharmacy file with outpatient pharmacy dispensing records, and an enrollment file that provides demographic data and dates of insurance eligibility for persons in the database. Laboratory test results are also available for a fraction of the population. In addition, i3 Drug Safety will complement the data from the NHI Database with data from the Ingenix National Managed Care (Impact) Database, a fully de-identified, HIPAA compliant database from health insurance claims and enrollment data of more than 30 health plans separate from the plan affiliated with the NHI Database. Patients in each data source have a common unique identifier; therefore, it is possible to construct a combined population without concern that some patients may be duplicated.
Key inclusion criteria (1 listed)
- All patients aged 18 years or older with an initial claims diagnosis of HIV infection associated with a physician visit occurring after at least 6 months (183 days) of continuous enrollment between 01 January 1998 and 31 December 2007 will be included in the primary cohort. Patients will be required to have commercial health insurance coverage and complete medical and pharmacy benefits. The cohort entry date for each patient will be limited to the first claim associated with a HIV infection diagnosis that meets the 6-month continuous enrollment criteria. Patients with a HIV infection diagnosis claim who do not have at least one continuously enrolled segment that is equal to or greater than 6 months prior to the cohort entry date will be excluded. Six months of continuous enrollment prior to the initial claim associated with a HIV infection diagnosis will be required to guarantee the availability of a 6-month baseline period for ascertaining exposure to HAART prior to cohort entry and covariates of interest for the Poisson regression models. Patients may enter the primary cohort already exposed to HAART and with a HIV infection diagnosis claim in the 6-month baseline period.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| HAART TreatmentUsing pharmacy records, identify all patients with HAART dispensing during baseline \& follow-up periods. For combination medications, classify person-time according to individual therapeutic components. HAART exposure classification by 1)any HAART exposure, 2)by HAART class, and 3)by specific nucleoside reverse transcriptase inhibitor exposure. Specific evaluation of fosamprenavir and amprenavir. Subdivide person-time according to recent, past \& non-use of HAART. Person-time for each patient partitioned into exposure windows of Recent use(From start of dispensing to end of days supplied plus 6 months), Past use(From end of current use to end of follow-up or new HAART dispensing following recent use), \& Non-use(Time prior to first dispensing or all time for those who did not receive a dispensing). Determine cumulative duration of exposure based on days supplied per dispensing per patient over the baseline \& follow-up periods: Non-use, Less than 1 yr, 1-2 yrs, More than 2yrs. | Drug | HIV infected patients: HAART naive or experienced, Patients with HIV infection HAART naïve |
Primary outcome
Incidence rate of acute myocardial infarction, AMI including coronary revascularization (CR) procedures, and cardiovascular disease (MI, other ischemic heart disease, congestive heart failure, peripheral vascular disease, cerebrovascular disease)
Time frame: During periods of recent, past, non-use, and cumulative duration (non-use, < 1 year, 1 - 2 years, and > 2 years) of each HAART exposure classification.
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 Jul 2011.
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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.
GSK Clinical Trials study director
ViiV Healthcare
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and Cardiovascular Disease, run by ViiV Healthcare.
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 1 inclusion and 1 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 Jul 2011. 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?
Incidence rate of acute myocardial infarction, AMI including coronary revascularization (CR) procedures, and cardiovascular disease (MI, other ischemic heart disease, congestive heart failure, peripheral vascular disease, cerebrovascular disease) (time frame: During periods of recent, past, non-use, and cumulative duration (non-use, < 1 year, 1 - 2 years, and > 2 years) of each HAART exposure classification.). 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 Jul 2011.