Fracture, Infection, Human Immunodeficiency Virus
Conditions
Keywords
Combivir (Zidovudine+Lamivudine), Trizivir (Abacavir+Lamivudine+Zidovudine), Zidovudine, Epzicom (Abacavir+Lamivudine), Fracture, Amprenavir, human immunodeficiency virus (HIV) infection, antiretroviral (ARV) therapy, Lamivudine, incidence, Abacavir, risk, Fosamprenavir
Brief summary
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.
Detailed description
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.
Interventions
OTHERNo Antiretroviral (ARV) Drug Exposure
No pharmacy dispensing of an ARV drug
DRUGAny Antiretroviral (ARV) Drug Exposure
Pharmacy dispensing claim for any ARV drug
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 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 |
Outcome results
None listed