ACRIA Update, Vol. 10, No. 3, Summer 2001
CRIA has begun enrollment on this multicenter study that follows-up on a national level a previous pilot study that CRIA sponsored and conducted. This current 26-week, double-blind, randomized, placebo-controlled study looks at the effectiveness and safety of Serostim® (human growth hormone) when used to treat the abnormal fat distribution that occurs in patients treated with antiviral drugs for HIV infection. Patients with the condition know as HARS (HIV-related adipose redistribution syndrome) often have increased amounts of fat in the abdomen, the upper back, and (especially in women) in the breasts. If you are an adult who is HIV+, are on a stable anti-HIV drug regimen, and have problems with abnormal fat distribution, you may be eligible for the study.
The purpose of this study is to determine if an HIV-1 RNA genotype report is effective and safe to use for choosing therapy for HIV infection. We will be gathering data regarding an experimental test called genotyping, in this case the TruGene® HIV-1 Assay, developed by Visible Genetics Inc. Genotyping may allow doctors to see which drugs may or may not work against HIV infection. It may tell you if HIV may be resistant to certain drugs. Resistance means that the drugs given to you for your HIV may not work as well as thought. Genotyping is still being studied as an aid in treating HIV infection.
You may be eligible for this study if: 1. you are an HIV-1 infected person with a viral load of greater than or equal to 1,000 copies/mL 2. you and your doctor have determined that a change in your anti-HIV therapy is indicated; or if no prior therapy has been given for HIV-1, then you and your doctor agree that therapy needs to be started.
You will come in for one blood draw specifically for the study. This blood will be used for the genotyping test. Your personal doctor will get the results of the genotyping test within 7-10 business days and use these results to help choose a drug regimen that may be beneficial to you. We will gather data about your progress (up to one year) from later blood draws by your personal doctor that are part of your regular care. You will be paid $15 after enrolling into the study to cover transportation, lost time from work, or meals. Your insurance company or a state health insurance agency will be billed for the blood tests. If you do not have insurance or state coverage and if you cannot pay for the tests, your study doctor will try to enroll you in a special patient assistance program.
For more information on these studies, please call Dr. Douglas Mendez at (212) 924-3934, ext. 126 or visit our Web site: www.criany.org
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