ACRIA Trials in Progress
Atazanavir vs. Viracept in Protease Inhibitor Naive Individuals
This research study will compare the safety and effectiveness of atazanavir (BMS-232632) to Viracept (nelfinavir) in people who have seen their viral load rise while taking HIV drugs that did not include a protease inhibitor. Atazanavir is an experimental new protease inhibitor developed by Bristol-Myers Squibb Company.
Participants will be randomly assigned (like flipping a coin) to take either: 1. Atazanavir (active drug) and placebo (inactive) nelfinavir, or 2. placebo (inactive) atazanavir and nelfinavir (active drug). Everyone in the study will also take two nucleoside reverse transcriptase inhibitors (NRTIs).
If you are an adult with HIV, have a CD4 count of 50 or more, a viral load of 1,000 or more, and have been taking anti-HIV medications but have NOT taken any protease inhibitors (or have had very limited use of them), you may be eligible for the study.
The study will last approximately 52 weeks, during which time participants will have to make 12 scheduled visits to ACRIA. All blood tests, study visits, and study drugs will be provided at no charge to the participants. Reimbursement: Once you have been enrolled in the study, you will be reimbursed $18 per visit to cover lost time from work, transportation costs and/or meals.
Vigilance II Genotyping 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 have HIV and a viral load of 1,000 copies or more, 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 these studies, please call Dr. Douglas Mendez at (212) 924-3934, ext. 126 or visit our Web site: www.acria.org.
This article was provided by AIDS Community Research Initiative of America. It is a part of the publication ACRIA Update. Visit ACRIA's website to find out more about their activities, publications and services.