NIH Clinical Research Studies

Protocol Number: 98-I-0070

Active Accrual, Protocols Recruiting New Patients

Title:
Magnetic Resonance Imaging of the Face and Bones
Number:
98-I-0070
Summary:
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.

Sponsoring Institute:
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Adult patient (18 and older) Amended 7/1 to children 4 and over 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, known HIV infection, based on patient history or NIH or referring physician records; for hip MRI of patients with known AVN, AVN previously diagnosed by X-ray or MRI scans.

HIV-Negative Volunteers for Hip MRI:

Adult patient (18 and older).

Willing and able to provide written informed consent.

No known risk factor that might increase the risk of MRI

Not known to be HIV-infected, based on patient history (HIV testing will no be performed)

No known major risk factor for AVN

Not known to have AVN, hip replacement, or hip disease

To be recruited with demographics similar to study population

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:

a. current or prior employment as a welder or metalworker

b. presence of cardiac or neural pacemaker, aneurysm clip, cochlear implant, metallic implant such as artificial cardiac valve, shrapnel, or permanent, non-removable body jewelry.

Special Instructions:
PROTOCOL CLOSED TO ENROLLMENT OF NORMAL VOLUNTEERS.
Keywords:
Protease Inhibitor
HIV Infection
Appearance
Subcutaneous Fat
Recruitment Keywords:
Facial Wasting
Conditions:
HIV Infection
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Recombinant granulocyte-macrophage colony-stimulating factor enhances the effects of antibiotics against mycobacterium avium, complex infection in the beige mouse model

Clarithromycin therapy for bacteremic mycobacterium avium complex disease

Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic mycobacterium avium, complex disease in patients with HIV infection

Active Accrual, Protocols Recruiting New Patients

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