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CRIA Trials in Progress

Winter 1999-2000

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 was 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 study is closed to enrollment.

Metabolic Effects of Protease Inhibitors
CRIA is conducting 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.

SB-300 for Diarrhea (Currently Enrolling)
CRIA is currently enrolling a 2-week pilot study of the dietary supplement SB-300 in the treatment of chronic diarrhea in HIV+ individuals. SB-300 is a standardized herbal extract that contains a compound that has been isolated and purified from trees of the Amazonian rainforest. HIV-infected adults who have had chronic diarrhea (three or more stools a day) for at least two weeks may be eligible for this study. There will be a total of 3 study visits. Study participants will be provided with a $3 MetroCard at each visit.

Topical Aspirin for Peripheral Neuropathy (Currently Enrolling)
CRIA is now enrolling a 5-week double-blinded study looking at the efficacy of topical aspirin to treat painful sensory peripheral neuropathies in people with HIV. Over the course of the trial, participants will be given two separate bottles of solution: one with aspirin in diethyl ether, another with an inactive placebo in diethyl ether. The order in which these bottles will be provided is randomized. The solution will be applied on the skin over the painful area 3 times a day. HIV-infected adults with painful sensory neuropathy that has been present for at least a month are eligible. There will be a total of 5 study visits. Study participants will be provided with a $3.00 MetroCard at each visit.

Ultrase for Diarrhea (Currently Enrolling)
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 1,250 mg twice a day for at least two weeks and who 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 stories, please call (212) 924-3934 ext. 126 for Dr. Irene Cergnul or ext.124 for Dr. Douglas Mendez, or visit our Web site (

Editor's Notes

  • All material in CRIA Update is presented for educational and informational purposes only, and is not intended as medical advice. All decisions regarding one's personal treatment and therapy choices should be made in consultation with a physician.

  • CRIA Update refers to all drugs by both their commercial and scientific names upon their first reference in an article. Thereafter in the article, they will be identified with the name by which we feel they are most commonly known, either commercial or scientific.

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This article was provided by AIDS Community Research Initiative of America. It is a part of the publication CRIA Update. Visit ACRIA's website to find out more about their activities, publications and services.