Fat Accumulation in the Belly (FAB) Study
Fat build-up in the abdomen may be a complication of protease inhibitor use. CRIA is conducting a pilot study on the effect of Recombinant Human Growth Hormone (Serostim®) in the treatment of truncal obesity associated with HIV infection. The protocol is designed to examine the safety and efficacy of daily human growth hormone injections over a 24-week period. An extension phase is now being conducted for patients who have completed 24 weeks of therapy to determine longer-term effects. This trial is closed to enrollment.
Metabolic Effects of Protease Inhibitors
CRIA is launching a study in cooperation with Dr. Ann Danoff, Chief of Endocrinology at Bronx-Lebanon Hospital to examine whether there is an association between short-term antiretroviral therapy (ARV) and glucose intolerance, hyperlipidemia, or body habitus changes. The trial will study HIV negative persons who have sustained needle stick injuries, before and at the conclusion of a course of ARV prophylactic therapy. This study will provide the opportunity to examine the impact of PI therapy independent of HIV infection.
Protease Inhibitor and Blood Sugar Study
CRIA is conducting a study to examine the effects of protease inhibitor use on responses to the oral glucose tolerance test (measurement of blood sugar levels after taking a drink with a high sugar content) on HIV positive persons. Participants must have been naive to protease inhibitors to participate in this study. This trial is closed to enrollment.
Topical Analgesic for Peripheral Neuropathy
This small pilot study will look at the effectiveness of a topical non-steroidal analgesic for the treatment of pain associated with peripheral neuropathy in HIV infected persons. If the results show promise CRIA plans to develop a full protocol.
Ultrase® for Diarrhea
CRIA is participating in a study of Ultrase (pancreatic enzymes) for diarrhea due to the protease inhibitor nelfinavir (Viracept®). The 12-week study, which is being conducted along with CRI New England and CRI South Florida, is open to HIV-infected persons who have been taking nelfinavir at a dose of 1250 mg twice a day for at least two weeks and have three or more stools per day not due to any other cause. Participants will be reimbursed $20 per visit after enrollment.
For more information on any of these studies, please call Dr. Irene Cergnul or Dr. Douglas Mendez at (212) 924-3934, or visit our Web site (www.criany.org).