MRI Evaluation of Avascular Necrosis in HIV-Infected Patients
This study aims to observe and evaluate the presence of avascular necrosis in individuals infected with HIV, using MRI scans.
Data Collection
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Summary
Study start date: February 23, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.532 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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: current or prior employment as a welder or metalworker presence of cardiac or neural pacemaker, aneurysm clip, cochlear implant, metallic implant such as artificial cardiac valve, shrapnel, or permanent, non-removable body jewelry. Surgery within the last 6 months with the use of metal clips.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps