Fracture Clinical Trial
Official title:
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.
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