Trial record 8 of 41 for:    " December 30, 2009":" January 29, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

HIV Treatment and CVD Events

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01054638
First received: January 21, 2010
Last updated: July 26, 2011
Last verified: July 2011
  Purpose

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:

1. 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

Condition Intervention
HIV Infection
Cardiovascular Disease
Infection, Human Immunodeficiency Virus
Acute Myocardial Infarction
Drug: HAART Treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: HIV Treatment and CVD Events - Ingenix. Retrospective Database Analysis of Patients With Human Immunodeficiency Virus (HIV) Treatment and Cardiovascular Disease (CVD) Events

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Drug: HAART Treatment

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.

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.
Drug: HAART Treatment

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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054638

Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01054638     History of Changes
Other Study ID Numbers: 112872, EPI40543, WEUSKOP3283
Study First Received: January 21, 2010
Last Updated: July 26, 2011
Health Authority: United States: No Health Authority

Keywords provided by ViiV Healthcare:
HIV
HIV Infections
amprenavir
fosamprenavir
HAART treatment
Epzicom
Trizivir
Combivir
zidovudine
lamivudine
cardiovascular disease

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Cardiovascular Diseases
Immunologic Deficiency Syndromes
Infarction
Myocardial Infarction
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Fosamprenavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014