NCT01077557

Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status

Fractures Over Time Stratified by HIV Infection and Antiretroviral Therapy (ART) Exposure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fracture
• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-11-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-03-01
• Last updated: 2017-06-01