A clinical trial is a research program that tests a new medicine to see if it is safe and works well. When a new medicine (or drug) is first discovered, you cannot get it by prescription. Researchers must first test it in a laboratory with animals. Then, they must do a clinical trial in a hospital or clinic to test it in people. They test it to see if it is safe and to see how much of the medicine (or what dose) is enough to work.

The Food and Drug Administration (FDA) (http://www.fda.gov) is a government agency that decides if a new drug is safe enough to give to patients by prescription. It looks at the results of the clinical trials to make this decision. Testing drugs for HIV is very important, and clinical trials are a way to find new and better medicines. All medicines that you can now get for HIV were first tested in clinical trials.

Clinical trials follow a set of rules called a protocol. The protocol says who can participate, how long the study is, and which tests need to be done.

Clinical trials are managed by doctors and are usually run by nurses or other health care professionals. The clinical trial staff will follow your progress closely and can help tell your regular doctor what is happening with your treatment.

Trials are also checked by an institutional review board (IRB). This is a group of people who reviews the clinical trial regularly to protect your rights, safety, and well-being.

When you are in a clinical trial, you may need to see the doctor more often and sometimes stay overnight in the hospital. This is because they want to check the effects of the medicine carefully. Because clinical trials are research, they will often test the real drug against a placebo (or sugar pill). Usually you will not know if you are taking the medicine or the placebo until the clinical trial is over.

Before you start a clinical trial, you will go through a screening process. This is to make sure that it is safe for you to start taking the medicine. The staff will ask you about your health history, and you may have a blood test, urine test, or others (such as a physical exam or a heart test).

You will also go through a process called informed consent. The doctors and nurses will explain exactly what will happen during the clinical trial. They will answer your questions and tell you about the risks and benefits of the clinical trial. They will ask you to sign a document called a consent form. When you sign this form, you are saying that you understand what is going to happen and that you agree to participate. Even after you have started a clinical trial, you are free to quit at any time for any reason. Quitting early will not affect your medical care in the future.

No. It will not cost you anything because you are helping the researchers to test a new medicine. Sometimes you may even get extra money to pay for your time or travel.

Clinical trials can last from a few weeks to several months. After the treatment is over, they will usually ask you to come back for some follow-up visits. The follow-up period may be as short as a few weeks or as long as six months and helps to make sure that you are safe.

There are four different types of clinical trials: Phase I, Phase II, Phase III, and Phase IV.

It usually takes about 10 years for a drug to be developed and approved for prescription. Many people would like to take the newest medicine as soon as it is proven to work. However, even after a drug has been successful in a Phase III trial, it still may take six to 12 months before that drug is approved for prescription.

Trials are paid for by government agencies, pharmaceutical (or drug) companies, individual doctors and hospitals, or clinics. The doctors and nurses will tell you who is paying for the study before you begin a trial.

Often, people want to join a clinical trial because their treatment isn't working. Not everyone can join a trial, though. Most clinical trials have eligibility criteria. These are rules about who can participate, based on health, age, and maybe other things. For example, some trials take only people who have a particular viral load or CD4 count. Usually, you can't participate in a clinical trial if you have any infections or are using medicines that might make it hard to measure how well the test treatment is working. You also cannot participate if the test treatment might harm you.

If you do qualify for a trial and decide to participate, you should be willing to follow the guidelines of the study.

Before you start a clinical trial, you should think about the positive and negative things that may happen. In addition, keep a list of questions to ask before joining a trial. (http://www.hiv.va.gov/treat-questions3)

• Why are they doing the study in the first place?
• How long will it last, and where is it taking place?
• What will I have to pay for?
• Will I be able to continue taking the test drug after the trial is over? Who will pay for it?
• Will I have to stop any drugs or other treatments I am now using?