Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status - Full Text View

Purpose

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.

Condition	Intervention
Fracture Infection, Human Immunodeficiency Virus	Other: No Antiretroviral (ARV) Drug Exposure Drug: Any Antiretroviral (ARV) Drug Exposure


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Retrospective
Official Title:	Fractures Over Time Stratified by HIV Infection and Antiretroviral Therapy (ART) Exposure

Resource links provided by NLM:

MedlinePlus related topics: Fractures HIV/AIDS

U.S. FDA Resources

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:

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 ]


Enrollment:	1
Study Start Date:	November 2006
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.	Other: No Antiretroviral (ARV) Drug Exposure No pharmacy dispensing of an ARV drug
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.	Other: No Antiretroviral (ARV) Drug Exposure No pharmacy dispensing of an ARV drug
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.	Drug: Any Antiretroviral (ARV) Drug Exposure Pharmacy dispensing claim for any ARV drug

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

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.

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: NCT01077557

Sponsors and Collaborators

ViiV Healthcare

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	ViiV Healthcare

More Information


Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT01077557 History of Changes
Other Study ID Numbers:	111950
Study First Received:	February 25, 2010
Last Updated:	February 2, 2012
Health Authority:	United States: No Health Authority

Keywords provided by ViiV Healthcare:


human immunodeficiency virus (HIV) infection Combivir (Zidovudine+Lamivudine) Trizivir (Abacavir+Lamivudine+Zidovudine) Zidovudine Epzicom (Abacavir+Lamivudine) Fracture Amprenavir	antiretroviral (ARV) therapy Lamivudine incidence Abacavir risk Fosamprenavir

Additional relevant MeSH terms:


Acquired Immunodeficiency Syndrome HIV Infections Infection Fractures, Bone Immunologic Deficiency Syndromes Wounds and Injuries Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases	Slow Virus Diseases Zidovudine Lamivudine Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents

ClinicalTrials.gov processed this record on September 23, 2016