CRIA Trials in Progress

Study of 3 Different Drug Combinations in Drug-Naïve, HIV+ Individuals

CRIA is participating in 96-week study sponsored by Glaxo Wellcome. It will look at the effect of three different anti-HIV drug combinations on people infected with HIV. Some individuals 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 adults who are HIV-1+, 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.

SAM-e for Depression in HIV+ Individuals
CRIA is currently conducting an 8-week open-label study of the efficacy and safety of using S-adenosylmethionine (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. 20 HIV-infected adults with diagnosed clinical depression have been enrolled in this study.

Directly Observed Antiretroviral Therapy (DART)
CRIA is currently conducting the pilot "Historical Prospective Study of Directly Observed Antiretroviral Therapy (DART)" with the CDC. Patient records from three types of settings providing antiretroviral therapy (AIDS residential health care facilities, day health centers, and ambulatory health clinics) are being compared to study the effect of DART on the clinical outcome of people living with AIDS. This research should generate data that will maximize the effectiveness of antiretroviral therapies and minimize the development of HIV resistance to these drugs.

Vigilance II Genotyping Study (Currently Enrolling)
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 TruGeneÔ 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 1,000copies/mL; and
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 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).