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Clinical Trials Frequently Asked Questions

Test TubesQ. Why are clinical trials important?
A. Clinical trials, sometimes called clinical research, are designed to improve the health care of people living with HIV/AIDS by studying promising treatments for HIV/AIDS to test how well they work and if they are safe for patients to use.

Before any drug is approved for use in the United States, the drug must be tested in various types of clinical trials. After testing is completed, the data is submitted to the US Food and Drug Administration (FDA) for review. The FDA must approve the drug before your doctor can write a prescription for you to obtain the drug.

Q. Are all clinical trials the same?
A. No. There are several different kinds of clinical trials being conducted at Trillium Health.

  1. Expanded Access Trials: The FDA allows promising HIV/AIDS drugs to be used before final approval to collect additional data. Trillium Health has been selected to participate in many Early Access Trials since 1989 - giving many patients expanded treatment options.
  2. Pharmaceutical Company-Sponsored Trials: These trials involve collecting information on a newly developed drug/drugs by the sponsor. These trials may collect information on proper dose, drug-drug interactions or simply how well their drug works as compared to another company's drug.
  3. Government-Sponsored Clinical Trials: Trillium Health is a part of the University of Rochester's Adult AIDS Clinical Trials Group (AACTG). The US AACTG is the largest HIV clinical trials organization in the world. Many of the same trials being conducted at the University of Rochester are also available on-site at Trillium Health. These trials research treatment regardless of the company that makes the drug. This means that sometimes, you could take several different drugs made by several different companies.

These trials also research how well your HIV medicines work with other drugs you may take, like medication for blood pressure or high cholesterol.

Q. Why should I enroll in a clinical trial?
A. There are several reasons to consider a clinical trial. The medication available in a clinical trial may be more effective for you than the medications you are currently taking. Clinical trials provide a safe way of making a new treatment available before the FDA approves the drug. The trials cover the expense of the drugs and treatments so they are provided at no cost to you.

Your participation in clinical trials not only helps you, it also helps others with HIV - both here and around the world.

Q. Are clinical trials safe?
A. Yes. "The Safety Net" for clinical trials includes the following:

A committee outside of Trillium Health approves all clinical trials before the trial starts, and monitors all the trial sites throughout the trial. The committee is called an Institutional Review Board or IRB.

In most trials, another committee works behind the scenes to make sure the trial is safe for patients. This Data Safety Monitoring Board (DSMB) can recommend that the trial be stopped if they feel the medication isn't working or isn't safe. This information is based on data collected and submitted to the sponsors for review.

Trillium Health does not enroll patients in clinical trials without written consent from the patient. This involves explaining the risks and benefits, answering questions and discussing concerns that the patients have.

Your medical provider is an important part of the Safety Net. Ask your provider if he or she thinks a clinical trial is right for you before you enroll. Your provider reviews blood tests and other test results as a part of the clinical trial. Your provider may recommend that you stop the trial if he or she feels that the trial medication is not right for you.

Q. What is a Placebo and do all trials have them?
A. Placebo trials are studies in which a group of patients receive medication that looks like the medication being studied, but are really an inactive pill or "sugar pill."

HIV trials will combine a placebo drug with other real drugs against the study drug and other real drugs. This tells the researchers how well the study drug performs. You will be told in advance if a trial involves the possibility that you would receive a placebo.

Q. Who do I contact for more information about any of these clinical studies?
A. Contact Roberto Corales, D.O. at rcorales@trilliumhealth.org or 585-210-4118.