ARA | Current Clinical Trials

Clinical Trials 101
(A Crash Course on Clinical Trials)

Deciding to participate in a clinical trial is an important personal decision. AIDS Research Alliance has prepared this document in order to answer frequently asked questions and provide you with detailed information about clinical trials.

What is a Clinical Trial?

A clinical trial is a research study in which experimental drugs or treatments are tested in volunteers under the close supervision of a doctor and clinical staff. Clinical trials can be conducted at universities, hospitals and research centers (non-profit, governmental, or private). Clinical trials determine if experimental drugs are safe and effective. All drugs, from penicillin to AZT, have gone through clinical trials before they are approved by the government and available to the general public.

What is an HIV/AIDS Clinical Trial?

An HIV/AIDS clinical trial is a study of new drugs or treatments specifically for HIV infection and AIDS. Some HIV/AIDS clinical trials study medications for specific symptoms or opportunistic infections; other studies focus on decreasing viral load and/or raising T-cell counts.

Why Should I Participate in a Clinical Trial?

People participate in clinical trials for a variety of reasons which may include:

• You may have a disease for which there is no cure or effective treatment.

• Your disease might not respond to current medication options.

• You might join a clinical trial hoping to get improved medical care.

• Clinical trials are a way to get medical care even if you are uninsured.

What is a Study Protocol?

• A study protocol is the "map" of how the study will be conducted and describes every step of the study. The protocol lists what the comparison groups will be, what tests will be done, what dosages of the drug are being studied or what drug combinations are being studied.

What is the Inclusion/Exclusion Criteria?

• The Inclusion/Exclusion criteria are certain requirements that you have to meet before you are allowed to join a study. Each clinical trial has a different set of Inclusion/Exclusion criteria.

What is a Placebo and Why is it Used?

• A placebo is essentially a "fake" pill that is a harmless substance that is given to some study volunteers instead of the actual drug. A placebo is used to compare results with the study drug so that researchers know if the drug actually works. Usually, neither the patients nor the clinical staff know who is receiving a placebo and who is not (this is called a "double-blind" study"). Study participants receive the same level of medical attention and care whether they receive the placebo or experimental drug. Frequently, the study patients who receive the placebo are given the opportunity to take the experimental drug if it is shown to be safe.

What is the Informed Consent Form?

• The Informed Consent is a document that you are required to sign prior to participating in a study. The Informed Consent explains the study protocol including possible risks and benefits, what tests will be performed and what you are agreeing to do as a participant. Signing the Informed Consent indicates only that you understand the clinical trial, all of your questions have been answered and that you have decided to participate. The Informed Consent is not a contractÑyou may leave the study at any time and are not obligated to stay in the study because you signed the consent form.

What is an Institutional Review Board?

• The Institutional Review Board is a panel of outside experts and community members who review and approve every proposed clinical trial and ensure that the trials are conducted in an ethical manner and that patients are informed about their rights, the study procedures and potential risks.

What are the Different Phases of a Study?

Drug studies have many phases before they are approved by the Federal Drug Administration (FDA) and made available to the public.

• Preclinical research is the first step of a study. The drug is first tested in a test tube to see if it is effective. Then, the drug is tested on animals.

• Phase I studies test the drug to see if it is safe in humans, and if so, what amount (e.g. milligrams) is safe. These studies are conducted in a small number of patients (usually 10-30) for a short period of time (usually 2-12 weeks). Phase I trials have the most risks for patients because this is the first time that the drug has been tested in humans.

• Phase II studies look at the on-going safety and effectiveness of the drug and involve a moderate number of patients (50-100).

• Phase III studies are a larger evaluation of the drug's safety and effectiveness. This usually involves a large number of patients (300-5000). Phase III studies are the final step before the FDA approves the drug. The FDA must approve all drugs before they go on the market and can be prescribed by doctors.

• Phase IV studies take place once the drug has already been approved by the FDA and is allowed to be marketed by the drug company and prescribed by physicians. Usually, studies at this level involve looking at long-term side effects of the drug and its use in combination with other drugs.

What Should I Expect When I Participate?

You should expect the following:

• The clinical staff will answer all of your questions and address all of your concerns about the study.

• The study site will protect your confidentiality.

• You may have many appointments at the clinic—and it is important for you to keep all of them!

• You must take the study medication exactly as directed.

• You will need to be honest with the clinical staff and answer all of their questions as to how you feel and whether you've been taking the study medication correctly.

• You will be informed of any changes to the study protocol.

• You are able to leave the study for any reason at any time. You can not and should not be forced into participating or continuing in a clinical trial.

What are the Benefits of Participating in a Clinical Trial?

• You may receive potentially effective new drugs that are not available to the general public. And these drugs are free to you while you are on the study. You may even continue to receive drugs after the study ends.

• You will receive free medical care while on the study.

• If you participate in an HIV/AIDS clinical trial, you may receive free viral load and CD4 tests, along with other lab tests.

• You may receive specialized tests that you and your doctor have no other way of obtaining.

• You will be helping to insure that the study drug is safe and effective in people like youÑsome drugs act differently in women and people of color.

• You will be contributing to the advancement of medicine by helping to develop new medical therapies.

What are the Risks Involved in Participating in a Clinical Trial?

• The drug being tested may not work.

• The drug being tested may have unknown side effects or be unsafe.

• You might receive a placebo (fake pill or treatment) instead of the drug.

• The required blood draws may be uncomfortable.

• Some drugs require injections that may be uncomfortable.

What Happens After the Study Ends?

Several things might happen when a clinical trial ends. The pharmaceutical company might continue to provide the study medications to those patients that are responding well. Sometimes, a patient will no longer receive the investigational drug and will have to wait for the drug to become available to the general public.

Where do I Find HIV/AIDS Clinical Trials?

• Many AIDS service organizations list enrolling clinical trials in their newsletters.

• The Trials Search Guide: HIV Clinical Trials in California (published quarterly, call 800/ 492.5777).

• There are web sites that list clinical trials across the country:

AIDS Research Alliance lists our current clinical trials on our website. Click here to go to our current trial list. We also have a confidential mailing list that will send you information about our new clinical trials before we advertise them to the general public. Click here to join our confidential mailing list.

As a free service to the HIV community, ARA conducts live presentations of "Clinical Trials 101." We can come out to your agency weekdays, weeknights and weekends and we are able to present in both English and Spanish. To schedule a presentation at your agency, contact Michelle Simek, our Outreach Coordinator, at 310.258.2423.