Materials and Links

Objectives:

To address issues related to study design and endpoints for treatment of lipodystrophy syndrome(s).  

Background:

With the expanded use of potent antiretroviral therapies, people with HIV infection are living longer – and are experiencing a broad range of side effects. Lipodystrophy syndrome(s) is one such side effect that threatens the long-term success of antiretroviral therapy. Although concerns for fat redistribution and metabolic abnormalities were raised as early as 1999, the mechanisms and cause have still not been completely elucidated.

Studies have demonstrated a significant psychological and emotional impact caused by the body fat redistribution, including forced disclosure of HIV infection, depression, decreased self-esteem and problems in social and sexual relations.

Since the underlying cause is still unknown, there has been a strong focus on syndromic management. Some of these approaches have been to switch antiretroviral regimens, nutrition and exercise, surgical interventions and the use of other therapies such as the statins, recombinant human growth hormone and metformin. Most of the studies conducted with these interventions have had relatively small sample sizes and the durability of effect is unknown. Furthermore, there is no consensus on the appropriate surrogate markers, magnitude and durability of surrogate marker effects and/or other endpoints for clinical studies.

Status:

The Forum for Collaborative HIV Research will hold a half-day roundtable discussion on October 25th in Washington DC to discuss issues regarding appropriate endpoints for lipodystrophy studies. A summary of this roundtable discussion will be presented at the 6th International Workshop on Adverse Reactions and Lipodystrophy in HIV (25-28 October 2004, Washington DC)

Scientific chairs:
Dr. Bill Powderly(USA)

Project specific sponsors: