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CRIA Trials in Progress

Spring 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.

SAM-e for Depression in HIV+ Individuals (Currently Enrolling)
Enrollment has begun at CRIA for an eight-week open-label study of the efficacy and safety of using S-adenosyl-methionine (SAM-e) to treat depression in HIV+ individuals. SAM-e is a naturally occurring compound that is sold as a food supplement in this country. HIV-infected adults with diagnosed clinical depression may be eligible for this study. There will be a total of seven study visits.

SB-300 for Diarrhea (Currently Enrolling)
CRIA is currently enrolling a two-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.

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Study of Three Different Drug Combinations in Drug-Naive, HIV+ Women (Currently Enrolling)
CRIA is participating in a 96-week study sponsored by Glaxo Wellcome. It will look at the effect of three different anti-HIV drug combinations on women infected with HIV. Some women with HIV experience changes in body shape as a result of fat redistribution. The primary purpose of this clinical trial is to study this effect. The study is for adult women who are HIV+, have a CD4+ lymphocyte cell count greater than or equal to 50 cells/mm3, have a viral load greater than 1,000 copies/mL and less than 200,000 copies/mL, and have NOT received anti-HIV drugs in the past or have very limited use of certain anti-HIV drugs. Participants will be reimbursed $15 plus a $3 MetroCard per visit after enrollment.

Topical Aspirin for Peripheral Neuropathy (Currently Enrolling)
CRIA is now enrolling a five-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 topical aspirin, another with placebo. The order in which these bottles will be provided is randomized. The solution will be applied on the skin over the painful area three 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 five study visits. Study participants will be reimbursed $15 plus a $3 MetroCard at each 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).


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.
 

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