Who can participate in a clinical trial?

You may choose to participate in a clinical trial, but the researchers must determine whether you are eligible. Each clinical trial includes people who have the same or very similar health profiles based on specific inclusion and exclusion criteria. When selecting participants, researchers may consider these or other factors: CD4 or T-cell count, HIV viral load, past medical history, medication history, current medical status, and your willingness and ability to follow all of the trial's instructions and schedules.

What is an informed consent?

Before you agree to join a clinical trial, researchers must be sure that you understand everything about the study - risks, benefits, obligations, etc. The staff will explain the study in detail. Then they will ask you to read and sign an informed consent document and will give you a copy of the consent form.

What questions should you ask about the trial?

• What is the purpose of the clinical trial?
• What will I need to do to join the clinical trial?
• Are there standard treatments for my current medical condition?
• How does this study compare with any standard treatments?
• Will I know what drug I am taking?
• How often will I need to come to appointments, use study medications, and have medical tests?
• What side effects can I expect from participating in this clinical trial?
• What should I do if I get any side effects or feel uncomfortable during the clinical trial?
• How will my confidentiality be protected during the clinical trial?
• What kind of long-term follow up care will be provided as part of the clinical trial?
• Will the study medications be free?
• Will there be any costs involved in participating in the study?

How is the safety of participants protected?

There are some risks to participants in clinical trials, but the federal government has imposed mandatory safeguards to protect them. Each clinical trial is reviewed by an Institutional Review Board (IRB), a diverse group of people that must approve the trial. The IRB periodically reviews the clinical trial operations to ensure that the risks are as low as possible, and worth the potential benefits. Some trials also have community advisory boards. In addition, all study participants must read and sign informed consent documents. These documents ensure that participants understand the risks and potential benefits as well as their rights and responsibilities should they decide to participate in the study.

What are the benefits of participating in a clinical trial?

Study participants may be among the first people to try a new experimental medication. Other benefits include receiving HIV/AIDS health care related to the research study by HIV-experienced physicians and study nurses and helping others by adding to the medical information about HIV/AIDS. The medications, clinic visits, evaluations, and laboratory tests required by the research study will usually be free of charge. Medical information obtained during the clinical trial can be shared with your own health care provider.

What are the risks of participating in a clinical trial?

A study medication may not be helpful; in fact it may be harmful to you, or have side effects. The expected side effects are listed in the consent form and will be reviewed with you by the study staff. While in the study, you can use only treatments approved by the researchers - some you are taking now may not be allowed. After your part of the trial ends, you may not be able to continue receiving the tested drug - even if it worked for you.