- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01378494
Bone Mineral Density in HIV+ Patients
Bone Mineral Density in HIV+ Patients Recently Started on Antiretroviral Therapy (ART)
Utilizing an extremely well-characterized HIV cohort under observation as ART-naïve or since their first exposure to HIV treatment, the investigators will conduct a cross-sectional study with prospectively collected data to determine BMD in 200 subjects. Subjects identified were initially treatment naïve when entering the University of Alabama at Birmingham (UAB) 1917 HIV Clinic between 1999 and 2010; some have been under observation without being treated with ART therapy and others were newly started on ART therapy while under observation. For each subject, the investigators will determine associations between BMD and 1) cumulative viremia, 2) ART duration, and 3) ART type.
Hypothesis 1a: BMD will be lowest in HIV+ subjects with the highest levels of cumulative viremia.
Hypothesis 1b: BMD will be greatest in HIV+ persons with longest duration of ART therapy, after excluding those subjects treated with tenofovir.
Hypotheses 1c: BMD will be lower in subjects treated with tenofovir vs. other ART agents, after controlling for duration of therapy.
Additionally, the investigators will conduct a retrospective study in 100 patients HIV+ and were ART-naïve at the time of entry into the 1917 Clinic in whom the investigators will longitudinally evaluate the relationship between HIV viral load, inflammation, and bone turnover (through the measurement of HIV copy-years viremia, interleukin-6 {IL-6}, tumor necrosis factor alpha {TNF-a}, high-sensitivity c-reactive protein {hsCRP}, osteocalcin, and urine C-telopeptide {CTX}). The investigators will compare HIV patients at a similar stage of their disease who remain treatment naïve (either due to concerns for compliance or sufficient CD4 counts without treatment) (ART-) vs. those newly started on ART (ART+).
Hypothesis 2: Viral load, markers of inflammation, and markers of bone resorption will all decrease in ART+ vs. ART- persons.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35242
- UAB
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All treatment naïve patients seen in the 1917 Clinic between January 1, 1999 and December 31, 2010 will be identified.
- Of these patients, those who are currently under care at the time of the initiation of the study (>1 clinic visit in the past 12 months) will be eligible (regardless of current use of ART treatment).
Exclusion Criteria:
- Patients with a history of chronic renal failure (estimated GFR <30ml/min) will be excluded from the study.
- In addition, patients with a 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) will be excluded from participation.
- Patients treated with oral glucocorticoids and anticonvulsants will also be excluded.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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HIV+
HIV+ patients that entered the 1917 Clinic at UAB as naive to ART
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Bone Mineral Density
Time Frame: Baseline
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pro-inflammatory and bone turnover markers
Time Frame: 6-12 months apart
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Change in IL-6, TNF-alpha, CRP, P1NP, Bone specific alkaline phosphatase, Serum NTX, and TRACP 5b at 6 and/or 12 months, as samples allow
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6-12 months apart
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Collaborators and Investigators
Investigators
- Principal Investigator: Amy H Warriner, MD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F110105006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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