View Clinical Trial (Medical Research Study)
Fracture and Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)
| City: |
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Birmingham |
| State: |
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Alabama |
| Zip Code: |
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35233 |
| Conditions: |
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HIV - Osteoporosis |
| Purpose: |
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In a group of HIV-positive patients under observation since their first exposure to ART or
monitored off of ART, BMD changes over one year will be determined. For each subject, the
investigators will also determine associations between changes in BMD and 1) ART initiation,
2) cumulative viremia (measured by copy-years viremia), and 3) inflammation (evaluated
through the measurement of interleukin-6 {IL-6}, tumor necrosis factor alpha {TNF-a},
high-sensitivity c-reactive protein {hsCRP}).
Hypotheses: BMD will decrease less in persons initiated on ART than those monitored off of
ART, after excluding those subjects treated with tenofovir.
BMD will decrease most significantly in HIV-positive subjects with the highest levels of
cumulative viremia.
HIV-positive persons with highest cumulative viremia will have the highest levels of
inflammation, as measured by pro-inflammatory cytokines.
Additionally, the investigators will evaluate fracture incidence in a 5% National Medicare
sample and fracture association with the use of varying ART medications among dual-eligible
persons in Medicare and Medicaid datasets.
Hypotheses: Fracture incidence will be greater in HIV-positive subjects compared to
HIV-negative subjects.Fracture incidence will be greatest in subjects with the shortest
duration of ART exposure.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- treatment naïve patients seen in the 1917 Clinic between January 1, 2000 and May 1,
2010
- currently under care at the time of the initiation of the study (>1 clinic visit in
the past 12 months)
Exclusion Criteria:
- history of chronic renal failure (estimated GFR <30ml/min)
- known diagnosis of a metabolic bone disease (i.e. osteoporosis, primary
hyperparathyroidism, Paget Disease, Osteogenesis Imperfecta)
- multiple myeloma, cancer, untreated thyroid disease, or inflammatory bowel disease,
or persons currently treated with or plans to begin an osteoporosis-specific
medication (including estrogen)
- treatment with oral glucocorticoids and anticonvulsants
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| NCT ID: |
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NCT01591252 |
| Primary Contact: |
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Principal Investigator
Amy H. Warriner, MD
University of Alabama at Birmingham
Amy Warriner, MD
Phone: 2059344112
Email: warriner@uab.edu
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| Backup Contact: |
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Email: kdavison@uab.edu
Kentress Davison
Phone: 2059759308
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| Location Contact: |
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Birmingham, Alabama 35233
United States
Amy Warriner, MD
Phone: 205-934-4112
Email: warriner@uab.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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