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 may drop out.

What are the phases of clinical trials?

Each trial is part of one of the first three phases, or steps, noted below, 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 trials 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 trials network.