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Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01077557
First received: February 25, 2010
Last updated: February 2, 2012
Last verified: January 2012

February 25, 2010
February 2, 2012
November 2006
November 2011   (final data collection date for primary outcome measure)
Incident fracture defined by first ICD-9-CM code 733.1 or 800-829 during the follow-up period. Inclusion is restricted to four-digit codes for closed fracture. Exclusions will be codes for skull, face, chest, rib, open fracture, and crushing injuries [ Time Frame: From enrollment in IHCIS National Managed Care Benchmarked Database to whichever of the following three event dates comes first: date of first fracture, end date of IHCIS enrollment, or March 31, 2008 ] [ Designated as safety issue: Yes ]
Incident fracture defined by first ICD-9-CM code 733.1 or 800-829 during the follow-up period. Inclusion is restricted to four-digit codes for closed fracture. Exclusions will be codes for skull, face, chest, rib, open fracture, and crushing injuries [ Time Frame: From enrollment in HCIS National Managed Care Benchmarked Database to whichever of the following three event dates comes first: date of first fracture, end date of IHCIS enrollment, or March 31, 2008 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01077557 on ClinicalTrials.gov Archive Site
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Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status
Fractures Over Time Stratified by HIV Infection and Antiretroviral Therapy (ART) Exposure

This US population-based study will explore the incidence of and risks for fracture among adults with and without human immunodeficiency virus (HIV) infection. The objectives are to determine the incidence of fracture among persons with and without HIV infection, compare risk factors for fracture among persons with and without HIV infection, and to examine the associations of antiretroviral (ARV) treatment exposure for incidence and risk of fracture among persons with HIV infection.

This study uses data from the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database, a health insurance claims database. The study has two analytic components. The first is a retrospective cohort study comparing subjects without HIV infection to subjects with HIV infection for the incidence of and risk for fracture, including the use of anyARV drugs in persons with HIV infection. The second is a nested case-control study limited to persons with HIV infectiion within the cohort. Cases are those with incident fractures occurring after the diagnosis of HIV infection, and controls those without a fracture. Cases and controls will be compared for risk factors for incident fracture including ARV drug exposure. The drug exposures will include individual nucleoside reverse transcriptase inhibitors (NRTIs) (as permitted by sample size) and the other ARV drug classes.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Probability Sample

The study population will consist of adults (>18 years of age) with and without HIV infection continuously enrolled for at least 12 months in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database, a health insurance claims database, during the interval between January 1, 1997 and March 31, 2008, and with continuous eligibility for pharmacy benefits. Health plan enrollees in this database are located in the continental US

  • Fracture
  • Infection, Human Immunodeficiency Virus
  • Other: No Antiretroviral (ARV) Drug Exposure
    No pharmacy dispensing of an ARV drug
  • Drug: Any Antiretroviral (ARV) Drug Exposure
    Pharmacy dispensing claim for any ARV drug
  • No HIV infection
    Subjects without HIV infection (Group 1) are adults, 18 years of age and older, continuously enrolled for at least 12 months in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database, a health insurance claims database, during the interval between January 1, 1997 and March 31, 2008, and with continuous eligibility for pharmacy benefits. A 3:1 match of subjects without HIV infection to a subject with HIV infection will occur. Each member of the comparator group without HIV infection will be matched on gender, month/year of IHCIS enrolment, and duration of enrollment to the respective study subject with HIV infection.
    Intervention: Other: No Antiretroviral (ARV) Drug Exposure
  • HIV infection with no antiretroviral (ARV) drug exposure
    HIV infection with no ARV drug exposure (Group 2) represents adults, 18 years of age and older, continuously enrolled for at least 12 months in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database, a health insurance claims database, during the interval between January 1, 1997 and March 31, 2008, and with continuous eligibility for pharmacy benefits. HIV exposure will be identified by ICD-9-CM code 042 or v08 in one or more diagnostic fields. This group will have no pharmacy dispensing for ARV drugs.
    Intervention: Other: No Antiretroviral (ARV) Drug Exposure
  • HIV infection with ARV drug exposure
    HIV infection with ARV drug exposure (Group 3) represents adults, 18 years of age and older, continuously enrolled for at least 12 months in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database, a health insurance claims database, during the interval between January 1, 1997 and March 31, 2008, and with continuous eligibility for pharmacy benefits. HIV exposure will be identified by ICD-9-CM code 042 or v08 in one or more diagnostic fields. This group will have at least one pharmacy dispensing for an HIV antiretroviral drug.
    Intervention: Drug: Any Antiretroviral (ARV) Drug Exposure
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The inclusion criteria was continuous enrollment for at least 12 months in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database during the interval between January 1, 1997 and March 31, 2008, age 18 years of age and older, and continuous eligibility for pharmacy benefits during IHCIS enrollment.

Exclusion Criteria:

  • Exclusion criteria were membership in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database without a valid gender or age record, less than 12 months continuous enrolment, and member residence in the 'national' census region. This latter grouping represented members who were either not living in the continental US or were masked for confidentiality reasons based on IHCIS archiving of data per the Health Insurance Portability and Accountability Act.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01077557
111950
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ViiV Healthcare
GlaxoSmithKline
Study Director: GSK Clinical Trials ViiV Healthcare
ViiV Healthcare
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP