Protocol Details

Magnetic Resonance Imaging to Study Avascular Necrosis in HIV-Infected Subjects

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	98-I-0070
Sponsoring Institute	National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Max Age: N/A
Referral Letter Required	No
Population Exclusion(s)	Children
Special Instructions	PROTOCOL CLOSED TO ENROLLMENT OF NORMAL VOLUNTEERS.
Keywords	Protease Inhibitor; HIV Infection; Appearance; Subcutaneous Fat
Recruitment Keyword(s)	Facial Wasting
Condition(s)	HIV Infection
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Institute of Allergy and Infectious Diseases

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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Eligibility

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:

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.

c. Surgery within the last 6 months with the use of metal clips.

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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

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Contacts:

Principal Investigator	Referral Contact	For more information:
Joseph A. Kovacs, M.D. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 2C145 10 Center Drive Bethesda, Maryland 20892 (301) 496-9907 jkovacs@niaid.nih.gov	Mary McLaughlin, R.N. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 8C404 10 Center Drive Bethesda, Maryland 20892 (301) 435-8001 mmclaughlin@niaid.nih.gov	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 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00001762

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