University of Washington Lipodystrophy Study

We have made enormous strides over the past 5 years in the care of individuals with HIV infection. The advent of protease inhibitor (PI) drugs in 1996, as well as other newer antiviral medications, has saved countless lives and spared much of the suffering formerly associated with AIDS. Nevertheless, potent new drug combinations may cause significant problems of their own. In 1997 we first recognized the syndrome of lipodystrophy. This syndrome includes fat loss from the face, arms and legs, causing visible alterations in shape and contour, along with fat accumulation in the abdomen, producing a paunch. Affected individuals may also develop diabetes, high blood pressure, or dangerously elevated blood cholesterol and fat levels. These abnormalities are known to lead to earlier or more severe heart disease. While this syndrome was originally thought to be associated directly with PIs, we now know that it is present in individuals on no medicines or on medicines other than PIs. Because we do not understand the exact cause and best treatment of lipodystrophy, the syndrome is an important target for research in medical centers around the country.

The University of Washington initiated a detailed clinical study of lipodystrophy in 1999. This project, funded by the National Institutes of Health, studies individuals for up to 24 months. Our aim is to better understand the metabolic and hormonal changes that may lead to alterations in body fat distribution. We are in the final 6 months of recruitment for the study and are actively seeking new participants. The goal of our research is to determine if lipodystrophy is caused by subtle changes in the metabolism of the hormones cortisol and insulin. A very small increase in production of cortisol by the adrenal glands, or a decrease in muscle and liver responsiveness to insulin produced by the pancreas, could lead to the body composition changes seen in lipodystrophy. In addition, we are evaluating whether several key genes that determine the size and growth of fat cells might be implicated in the syndrome.

In order to be eligible for the study, an individual must be planning to start antiviral medications for the first time or to change at least two drugs in his or her current antiviral treatment program, within the next 2 to 4 weeks. Individuals who already have signs of lipodystrophy, including loss of fat from the face and extremities or increase in abdominal size, are not able to participate.

Subjects will be evaluated by Pat Breen, R.N., the Study Coordinator, and scheduled for the first of three inpatient visits to the Clinical Research Center (CRC) of the University of Washington. This first CRC visit must occur prior to starting or changing medicines. Each of the three inpatient visits involves a 48-hour hospital stay (2 days and nights). The first visit occurs just before the change in medications, the second occurs at 2 months, and last at 12 months after the change in medications.

During the inpatient study visits, intravenous lines are placed for blood draws to measure a variety of hormones. We also perform two body composition X-rays, and Dr. Scott Weigle, the Principal Investigator of the study, will take small fat samples from the thigh and abdomen. There is a half-day outpatient visit to the CRC at 6 months, and optional half-day visits at 18 and 24 months for body fat measurement. Subjects are paid up to $1,200 for participation, and all study results are made available to the subject and his or her caregiver. If you would like to be a part of this important effort to improve the care of all individuals with HIV infection, please contact Pat Breen at (206) 731-6749.