View Clinical Trial (Medical Research Study)
Magnetic Resonance Imaging to Study Avascular Necrosis in HIV-Infected Subjects
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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HIV Infection |
| Purpose: |
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This study will examine risk factors for facial wasting and avascular necrosis (AVN, a type
of damage to the hip and other bones) in HIV-infected patients. The prevalence and natural
history of AVN are also being evaluated. This study will use magnetic resonance imaging
(MRI) to identify and monitor these conditions in patients with and without diagnosed AVN
and to identify risk factors.
HIV-infected patients 18 years of age and older may be eligible for this study. HIV-infected
children 4 years and older who can tolerate magnetic resonance imaging without sedation may
also participate. Candidates may be screened for participation with a medical history,
physical examination, blood and urine tests and possibly an electrocardiogram. Volunteers
will provide a medical history and may have a brief physical examination. The study is
currently closed to normal volunteers.
HIV-infected patients will have a MRI scan of the hip bone, and possibly other bones. Before
the scan, they will provide a medical history by interview or questionnaire and have a
physical examination. Those with diagnosed AVN will also have blood drawn to help identify
potential risk factors for AVN. For the MRI, the patient lies flat on a stretcher that is
moved into a cylindrical machine with a strong magnetic field. Earplugs are worn to muffle
thumping sounds produced by radio waves that form the images. Patients can speak with a
staff member via an intercom system at all times during the procedure. Repeat MRI studies
will be requested at approximately 3- to 12-month intervals for up to 5 years, to see if
changes occur with time. If medically indicated, additional diagnostic studies may be done
to obtain information needed for appropriate medical care. Blood will be drawn periodically
to examine immune parameters and viral blood levels. Patients with AVN may have periodic
consultations with the rehabilitation medicine service and orthopedic surgeons.
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| Study Summary: |
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In this minimal risk protocol, up to 400 asymptomatic HIV-infected patients and 75
HIV-infected patients with AVN will have MRI scans of the hips in order to determine (1) if
avascular necrosis (AVN) of the hip can be identified by MRI scans in HIV-infected patients,
and (2) to follow the natural history of asymptomatic and symptomatic AVN of the hip. Study
procedures include MRI of the hip, a minimal risk imaging study, and phlebotomy.
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| Criteria: |
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- INCLUSION CRITERIA:
Adult patients (18 and older) who are thought likely to tolerate the MRI without sedation.
Willing and able to provide written informed consent.
No contraindication to MRI as below:
For hip MRI of patients with known AVN: known HIV infection, based on patient history or
NIH or referring physician records, and AVN previously diagnosed by X-ray or MRI scans.
EXCLUSION CRITERIA:
Prior intolerance of head MRI (noise, claustrophobia, etc).
Pregnancy (fertile women must have a negative pregnancy test to within 2 weeks of the MRI
and must be using a reliable method of birth control).
Presence of specific contraindication for MRI:
1. current or prior employment as a welder or metalworker
2. presence of cardiac or neural pacemaker, aneurysm clip, cochlear implant, metallic
implant such as artificial cardiac valve, shrapnel, or permanent, non-removable body
jewelry.
3. Surgery within the last 6 months with the use of metal clips.
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| NCT ID: |
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NCT00001762 |
| Primary Contact: |
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Principal Investigator
Joseph A Kovacs, M.D.
National Institutes of Health Clinical Center (CC)
Mary McLaughlin, R.N.
Phone: (301) 435-8001
Email: mmclaughlin@niaid.nih.gov
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| Backup Contact: |
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Email: jkovacs@niaid.nih.gov
Joseph A Kovacs, M.D.
Phone: (301) 496-9907
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| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
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