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About Clinical Trials | About Participation | Enrollment Process | Comments From a Trial Participant

ABOUT CLINICAL TRIALS

What is a clinical trial?

HIV/AIDS clinical trials are carefully designed research studies that involve people and are designed to answer specific questions about the safety and effectiveness of treatment for HIV/AIDS and related conditions. Clinical trials are vitally important because there are no other direct ways to learn how different people respond to medications, treatments, or therapeutic approaches. Clinical trials are also called research studies or protocols.

All approved treatments for HIV/AIDS must be tested through clinical trials before they can be marketed to treat HIV infection or related conditions. HIV/AIDS clinical trials may provide critical information that can help people to live longer, healthier, and more comfortable lives.

What do clinical trials study?

Clinical trials may study experimental medications to treat HIV and AIDS, FDA approved medications used in new ways or in new combinations, or medications to prevent or treat related infections. They may also study ways to help persons manage their HIV/AIDS medications and the long-term general health of persons with HIV/AIDS.

What is a protocol?

To ensure reliable results, clinical trials follow precise medical guidelines or research plans called protocols. If you choose to participate, you accept the responsibility to observe these guidelines. So before you decide, make sure you know the number and length of appointments, medical tests required, and other medications allowed. You will need to commit the time required for the study and travel to your appointments. Although you can leave a clinical trial at any time, do not start one if you think you many drop out.

What are the phases of clinical trials?

Each trial is part of one of three possible steps, or phases, in development of a medication or treatment.

• Phase I Trials: A study medication is given to a small group of people for the first time, to measure its safety.
• Phase II Trials: The study medication is given to larger groups of people to see if it works and to further evaluate its safety.
• Phase III Trials: The study medication is given to very large groups of people to develop information that will allow the drug to be marketed and used safely.
• Phase IV Trials: Information about the study medication continues to be studied after marketing.

Who sponsors clinical trials?

HIV/AIDS clinical trial are developed and sponsored by the AIDS Clinical Trials Group (ACTG), by pharmaceutical companies, or by physician researchers. The National Institutes of Health (NIH), Division of AIDS (DAIDS), is the sponsor of the ACTG clinical trails network.

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ABOUT PARTICIPATION

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, your willingness and ability to follow all of the trial's instructions and schedules.

What is 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.

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ENROLLMENT PROCESS

What should I do if I want to participate in a clinical trial?

1. Review the list of Categories of Clinical Trials to see which studies are currently open for enrollment.
2. Refer to the list of Participating Sites for each study and contact your nearest ACTU site. Refer to the ACTU Locater map for contact information.
3. The contact person at the site will answer your questions about general study requirements and will help determine if there is a specific study for which you may be eligible. Your conversation will be completely confidential. You do not need to give your name or phone number.
4. If you are interested in finding out more about the studies that are available and if you are eligible for any of them, you should make an appointment for a screening visit at the clinic.
5. Obtain a copy of your medical records from your primary care provider that includes your HIV-related and other significant medical history, anti-HIV medication history, and recent laboratory results.

What happens during the screening visit?

1. During the screening visit, the study will be reviewed in detail and you will have an opportunity to ask any questions. If you decide to participate, the study nurse will review a consent form with you and ask you to sign the form to give us permission to proceed with the screening evaluations.
2. The evaluations done during the screening visit are to determine whether you would meet the eligibility criteria. In most cases blood samples will be drawn for laboratory tests, including a complete blood count, chemistries, HIV viral load, and CD4 count, and a physical examination will be done by the study doctor. The screening visit will take about 1 hour. You may need to return to the clinic for a second (pre-entry) visit before entering the study.

What happens during the clinic trial?

If screening tests show that you qualify to enter the study, the study nurse will schedule an entry visit. You will receive your study medication at the entry visit. There will also be additional lab tests done to get baseline values before starting your study treatment. During this visit the study medication dosing will be reviewed with you and you will receive information about possible side effects and phone numbers to call with questions or problems.

The frequency of your visits to the clinic will depend on the study. Studies vary in length from a few weeks to several years with follow-up visits every 4 to 8 weeks. Most follow-up visits consist of a brief physical exam, a review of your study medications, asking about symptoms and doing lab tests.

Will my primary care physician receive information about the clinical trial?

The ACTU staff will be in close communication with your primary care or referring physician. Your physician will receive copies of the lab results obtained through the study. The study staff will also contact them if you have any trouble with the study medication to discuss management and any changes needed in your study medication.

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COMMENTS FROM TRIAL PARTICIPANT

Karen was very concerned about treatment options when she was diagnosed with CMV retinitis. Her doctor told her about a clinical trial being conducted at an AIDS Clinical Trials Unit located approximately one hour from her home. He suggested that she consider becoming a participant.

Karen's understanding about clinical trials at that time was "That researchers were testing different drug combinations to see if any of them worked on the CMV". There were many questions she would need answered before she could decide whether or not to enroll in a clinical trial. "I was referred by my HIV doctor at the time to attend the Community Advisory Board meetings of our local unit". This is where Karen met others living with HIV and learned about the disease, new treatments and medications.

"I was scared about losing my sight and wanted to be checked very closely to make sure that it did not happen" Karen says. After investigating a clinical trial she felt, "It can't get better than this".

Predicaments like Karen's are not uncommon. "Patients have serious and life-threatening diseases. They're afraid. They want some options, but they're not sure where to go. We try to provide the information and alternatives that patients and their families need to make important decisions in such difficult situations" says Dr. William Powderly, Vice-Chair of the ACTG Executive Committee and the Principal Investigator at Washington University School of Medicine in St. Louis.

A PowerPoint slide presentation about Why Clinical Research is Important to Persons with HIV/AIDS can be viewed to learn more about the clinical trials process. back to top