ACTU: Q&A
Washington University's Response to AIDS
Acquired Immune Deficiency Syndrome (AIDS) is the most critical health issue facing our nation today. The number of people affected by HIV (Human Immunodeficiency Virus, the virus that causes AIDS) continues to grow. People with HIV and the medical communities are seeking answers to the many questions about HIV/AIDS. Clinical trials have helped to find better treatments and increase our knowledge of this disease. But extensive study must continue until a cure is found. Since 1987, the Washington University School of Medicine has been one of several national research institutions designated an AIDS Clinical Trials Unit (ACTU). Supported by the National Institutes of Health, the units are committed to improving the understanding of the AIDS virus and the development of effective treatments. The ACTU at Washington University is seeking individuals who are infected with HIV for evaluation to participate in the program.
A clinical trial is a study that allows doctors to examine the benefits and risks of using an investigational drug for a disease in people or already approved drugs in different ways. Clinical trials are the only way to find out if a drug is safe for people to take, and to find out if it works. Any drug that might improve the lives of people with HIV disease must go through careful testing before it will be made widely available to the hundreds of thousands of people who need treatment. Just a few years ago, we had almost no drugs to treat people with HIV. Today we have drugs that help people with HIV live longer, stay well longer and treat or prevent problems caused by AIDS. These drugs were proven to work because people with HIV helped test them. Most studies today compare an investigational drug or set of drugs with the one now being used to see which treatment works better. The ACTU is looking for men and women to help test drugs for AIDS.
Can anyone with HIV join a clinical trial?
To participate in an AIDS clinical trial, an individual must qualify for a study. Qualifications are different for each study and may include a person's age, symptoms of HIV disease or other illness, blood and other test results, and past treatments. The ACTU will evaluate all HIV-positive persons for possible inclusion in clinical trials.
Why do people take part in clinical trials?
People choose to participate in clinical trials for many reasons. Clinical trials can be a treatment option or enhance treatment. Participants in a trial are followed closely by the same medical team. When a medicine is proven to work, all those participating in a trial are the first to benefit. All or most of the treatment drugs and tests given while in the trial are free. A clinical trial may benefit the participant by offering a cure for the disease, a longer time to live, a way to feel better. Joining a study means taking positive action. Many are eager to participate in clinical trials because they want to contribute to an effort that may help others. The sooner studies are completed, the sooner improved methods of treatment will be available.
What types of treatments are being studied?
Clinical trials are currently studying treatments
in three broad categories:
treatments that may stop HIV's destruction of the immune system;
treatments that might help rebuild a damaged immune system; and
treatments that may prevent or cure the various illnesses that people
get with damaged immune systems.
Are the study drugs safe?
Before a drug is given to people it is first studied in the test tube and in animals to look for dangerous side effects. Before a clinical trial can begin it must be approved by the Food and Drug Administration, a panel of doctors, experts and other concerned individuals at each organization. Each center that conducts a trial is responsible by law for protecting the rights of the people in the trial and for ensuring that the trial is ethical and is as safe as possible. Individuals in a treatment trial are watched carefully because the investigational drug may have side effects. This allows the center staff to take steps to prevent or treat side effects if they do occur.
What is Informed Consent?
The principle of Informed Consent requires that people who are being asked to join a clinical trial understand a number of important things about the trial -- such as the purpose, the drugs that will be used, the possible dangers and benefits of the drug, the number of clinic visits needed, the tests that will be done, and so on. The consent is obtained before enrolling in a trial. A person may choose to leave the study at any time, and this will not affect medical care s/he routinely receives.
What are the responsibilities of people who enroll in a trial?
In order to be useful, trials must be run according to a set of rules that you must understand and agree to follow. The first responsibility is to understand what the rules are and to be honest about your ability to follow them. Typical rules include taking medicine everyday at the same time and letting the unit staff know what other medicines are being taken. Some trials may require many lab tests and visits to the clinic. These rules should be considered in the decision to participate. Even though tests and restrictions might seem like a lot of trouble they are designed to protect you against unknown side effects and get reliable information about the drug. For this reason it is very important to keep clinic appointments. Making the effort to follow the rules can help everyone.
Confidentiality
The medical school faculty and staff are sensitive to the privacy and concerns of patients and recognize the importance of confidentiality. They will make a major effort to ensure that all study records are protected. Data will be collected in the study without references to specific names.
Are there any fees?
Experimental drugs and related tests are provided by the ACTU free of charge. However, we are unable to cover all costs of services that are outside the scope of a particular study. These costs may be covered by private medical insurance or other funding sources.
Location and Parking
The AIDS Clinical Trials Unit is located in Suite 1200 at 4570 Children's Place. Parking is free on the adjacent lot.
What other services are offered by the ACTU?
Education In addition to the clinical and research studies, the Office of Communications provides further training to health care professionals through continuing education programs. The ACTU conducts symposia and provides clinical preceptorships to support the ongoing education of physicians and health care professionals so they can provide the best possible care to HIV-infected persons. The ACTU staff can also provide information about HIV/AIDS, nutrition, safer sex, and other treatment options.
AIDS Consultation Service A telephone consultation service is available to physicians providing primary care to HIV-infected persons. The ACTU consultants include experts in the fields of oncology, hematology, immunology, pediatrics, ophthalmology, obstetrics, infectious disease, pulmonary medicine, psychiatry, neurology and other specialty areas. These experts will provide the most up-to-date information in diagnosis, treatment, and care of AIDS patients.
Common Questions About Clinical Trials
What will happen if I decide that I no longer want to be part of a trial?
Nothing will happen to you. You can quit at anytime.
If the treatment I am receiving in a clinical trial is not working for me, can my therapy be switched?
Yes, your clinical trials physician, you, and your primary physician will discuss other options. While we cannot predict how one will respond to a particular treatment, no one will be asked to stay on a treatment that is not working for them.
Do patients ever receive sugar pills (placebos) instead of HIV treatment?
No, you will not receive placebo instead of HIV treatment.
What’s going to make it worth my while to come to the AIDS Clinical Trials Unit?
To gain access to the most promising therapies available, we will provide access to transportation and childcare.
What happens after the trial is over?
That depends on the trial. You may continue to receive the trial medicine, or you may want to get into another investigational trial.
I work, can you work around my schedule?
Yes, the staff at Clinical Trials will work with your schedule.
Are there any successful trials just for women?
Yes, one study of pregnant women showed how clinical trials have been used to advance the use of antiretroviral medication for women. The trial measured the effect of treating the pregnant women with AZT and treating the child during the birth process to determine if the rate of transmission to the child could be reduced. The study was so successful the decision to treat the mother during pregnancy and the birth process became an option for doctors.
I'm interested in a Clinical Trial, what must I do?
Contact the AIDS Clinical Trials Unit directly
at either of the numbers listed below. You can also speak with another
patient who is or has been on a clinical trial. Just let us know.
| Clinical Trials | |
|
Advantages You will be the first to be helped if an investigational drug is shown to work. You will get excellent health care at a leading healthcare facility from doctors who are experts in AIDS care. In most trials, all of your medications will be provided at no cost to you. You will be helping others with AIDS by joining a trial to test new treatments. Being in a trial gives you a sense of control over the disease and a chance to fight back. |
Disadvantages Some trials may require a lot of time and tests. The investigational treatment being tested may not work, have unpleasant side effects, or may make you worse. |
For More Information
Physicians and patients seeking information or
medical consultation are invited to call the ACTU office. Please call
(314) 454-0048 or (314) 879-6412 if there are questions concerning patient
eligibility or the status of studies being offered at the University.
Individuals may call (314) 362-2418 to reach the Office of Communications
and MATEC. Physicians, health care practitioners, individuals infected
with HIV and their families can find out more about AIDS Clinical Trials
by calling the AIDS Clinical Trials Information Service. The toll-free
number is 1-800-TRIALS-A (1-800-874-2572). This service is provided collaboratively
by the Centers for Disease Control, the Food and Drug Administration,
the National Institute of Allergy and Infectious Diseases and the National
Library of Medicine.
Division of Infectious Diseases
Department of Medicine
Washington University School of Medicine