AIDS clinical trials: talking it over.Preface pref·ace
a. A preliminary statement or essay introducing a book that explains its scope, intention, or background and is usually written by the author.
b. An introductory section, as of a speech.
"Clinical trials of experimental drugs are the only way to find out which drug works and which does not, and which drug is safe and which is not. All of us share a sense of urgency to see that safe and effective drugs to fight HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. infection and AIDS are discovered, tested, and made widely available as soon as possible."
Anthony S. Fauci, M.D.
NIAID NIAID National Institute of Allergy and Infectious Diseases. Director
The National Institute of Allergy allergy, hypersensitive reaction of the body tissues of certain individuals to certain substances that, in similar amounts and circumstances, are innocuous to other persons. Allergens, or allergy-causing substances, can be airborne substances (e.g. and Infectious Diseases infectious diseases: see communicable diseases. (NIAID) is one of the National Institutes of Health, the research arm of the U.S. Public Health Service. NIAID scientists conduct research on AIDS, and NIAID also provides funding to scientists outside of government who are doing AIDS research.
One of NIAID's goals is to find ways to treat diseases caused by HIV (the virus that causes AIDS). NIAID is testing new treatments in people with HIV infection. These research studies are called clinical trials. Careful clinical trials are the fastest and safest way to find out which treatments work.
At hospitals across the country, NIAID has set up a group of research centers, called AIDS Clinical Trials Units (ACTUs), where these tests take place. All these ACTUs together make up the AIDS Clinical Trials Group The AIDS Clinical Trials Group (ACTG) is the largest HIV clinical trials organization in the world, playing a major role in setting standards of care for HIV infection and opportunistic diseases related to HIV and AIDS in the United States and the developed world. (ACTG ACTG Acting
ACTG AIDS Clinical Trial Group
ACTG Actuating/Actuator ). In addition, doctors who are part of NIAID's Community Programs for Clinical Research on AIDS CPCRA, the Community Programs for Clinical Research on AIDS, is - according to their own website:
"an experienced community-based clinical trials network whose main goal is to obtain evidence to properly inform healthcare providers and people living with HIV on the most are conducting studies of AIDS drugs at hospitals and clinics in the communities where the impact of the AIDS epidemic epidemic, outbreak of disease that affects a much greater number of people than is usual for the locality or that spreads to regions where it is ordinarily not present. is severe. NIAID is also conducting studies at the National Institutes of Health. Clinical trials sponsored by drug companies, other government agencies, and private research organizations are also taking place.
People with HIV can volunteer to take part in these studies, and that is what this booklet
Clinical Trials: Talking it Over
This booklet is for people who are thinking about taking part in a study to test new drugs for HIV (the virus that may lead to AIDS). This includes people who have:
AIDS (acquired immune deficiency syndrome Acquired immune deficiency syndrome (AIDS)
A viral disease of humans caused by the human immunodeficiency virus (HIV), which attacks and compromises the body's immune system. );
Some symptoms of HIV (sometimes called ARC, or AIDS-related complex AIDS-related complex
n. Abbr. ARC
A combination of symptoms, including fever, lymphadenopathy, blood abnormalities, and susceptibility to opportunistic infections that is a precursor to AIDS in some individuals infected with HIV. ); or
HIV, but no symptoms of disease.
Joining such a study, which is called a clinical trial, is a big step. You need to find out all You can about what a trial may mean for your care, for your daily life, for those close to you, and for other people with HIV, ARC, or AIDS.
In this booklet, doctors and patients who are in clinical trials talk about what trials mean to them. They answer basic questions most people have, such as:
What is the purpose of clinical trials?
How do they work?
What trials may be open to me?
What is it like to be in one?
At the end of the booklet, you'll you'll
Contraction of you will.
you'll you will or you shall
you'll will find a checklist of issues you should think about--and talk to your doctor or nurse about--in making up your mind. Page 23 explains common terms you may hear as you ask about clinical trials.
Clinical Trials: Research for Progress
Today there are more questions than answers about how to care for people who have the AIDS virus AIDS virus
See HIV. . The research studies known as clinical trials are a key step in getting more answers.
Dr. Daniel Daniel, book of the Bible
Daniel, book of the Bible. It combines "court" tales, perhaps originating from the 6th cent. B.C., and a series of apocalyptic visions arising from the time of the Maccabean emergency (167–164 B.C. Hoth Noun 1. Hoth - (Norse mythology) a blind god; misled by Loki, he kills his brother Balder by throwing a shaft of mistletoe
Hoder, Hodr, Hodur, Hothr , director of the Division of AIDS at NIAID, explains how the studies can help. "Without clinical trials," he says, "finding a drug to treat AIDS would be like looking at a shelf with 20 bottles of medicine. You think some of them will work, but you don't know Don't know (DK, DKed)
"Don't know the trade." A Street expression used whenever one party lacks knowledge of a trade or receives conflicting instructions from the other party. which ones. The purpose of clinical trials is to find out. Then doctors can give their patients only the drugs that will help, and only those that are safe to take."
How Studies for AIDS Have Helped
Clinical trials for AIDS are new. Many are still in an early stage, needing more patients or more data before they can get good answers. But already trials have led to better treatments.
"Thanks to well-run clinical trials," Dr. Elaine Elaine, in Arthurian legend: see Launcelot, Sir.
disguises herself as Guinevere in order to seduce Lancelot. [Br. Lit.: Malory Le Mort d’Arthur]
See : Disguise
Elaine Eyster of the Hershey Hershey, uninc. city (1990 pop. 11,860), Dauphin co., S central Pa.; founded 1903 as a planned community built for workers at the Hershey Corp., the chocolate manufacturer that remains its largest employer. Medical Center notes, "we now have a treatment that helps some AIDS patients live longer: the drug AZT AZT or zidovudine (zīdō`vydēn'), drug used to treat patients infected with the human immunodeficiency virus (HIV), which causes AIDS; also called After only a year and a half of clinical testing, the studies found that patients with AIDS and ARC clearly lived longer when taking AZT. Within 6 months of this proof, more than 4,000 AIDS patients began to benefit from the new treatment."
Every trial will not find a drug that works. But studies also help improve care by finding that a drug clearly does not work. And every trial answers more questions, which brings us closer to the goal: effective ways to prevent, delay the onset of, and treat AIDS.
How Do Clinical Trials Work?
"In doing clinical trials," notes Dr. Paul Paul, 1901–64, king of the Hellenes (1947–64), brother and successor of George II. He married (1938) Princess Frederika of Brunswick. During Paul's reign Greece followed a pro-Western policy, and the Cyprus question was temporarily resolved. Volberding of San Francisco General Hospital San Francisco General Hospital is the main public hospital in San Francisco, California, and the only Level I Trauma Center serving San Francisco and San Mateo. The hospital budget is for only 302 beds at SFGH. , "we use the proven methods of science. The process is careful and exact. It can't always move as fast as we'd we'd
1. Contraction of we had.
2. Contraction of we should.
3. Contraction of we would.
we'd have ~would like and still give us results we can trust. But these methods have helped find good treatments for cancer, heart disease, and other infections. We can also rely on them to help us find better treatments for AIDS."
In early small studies, where the drug is being tested for safety and dose, each person who takes part gets the new drug being tested. In the larger trials that follow, doctors compare the new drug with another treatment to see which works better. These studies work like this:
* One group of patients gets the new drug.
* Another group gets a drug that is now used to treat the problem. If there is no drug that works for that problem, this group may get a look-alike look-a·like also look·a·like
One that closely resembles another; a double.
Noun 1. look-alike - someone who closely resembles a famous person (especially an actor); "he could be Gingrich's double"; "she's the very pill that contains no drug (called a placebo placebo (pləsē`bō), inert substance given instead of a potent drug. Placebo medications are sometimes prescribed when a drug is not really needed or when one would not be appropriate because they make patients feel well taken care of. ).
* Doctors compare the progress of the two groups to see if the people who got the new drug had better results than people in the other group. Did their symptoms go away? Did they stay healthy longer? Did they have side effects Side effects
Effects of a proposed project on other parts of the firm. from the drug? These are some of the questions clinical trials answer.
A key step in the process for patients is talking to Noun 1. talking to - a lengthy rebuke; "a good lecture was my father's idea of discipline"; "the teacher gave him a talking to"
rebuke, reprehension, reprimand, reproof, reproval - an act or expression of criticism and censure; "he had to research staff about what happens during the trial. Before you begin treatment in a study, the nurses and doctors explain why the trial is being run, risks you may face, how you may and may not be helped, what you will need to do, and how the study will work. Page 20 contains a list of questions you may want to bring with you when you talk to the staff. The list may help remind you of issues to raise.
You may also want to bring someone close to you to this meeting. Your loved ones loved ones npl → seres mpl queridos
loved ones npl → proches mpl et amis chers
loved ones love npl may want to find out what the study will mean for your health and daily routine. And talking the issues over with them later may help you decide whether a study is right for you.
Research versus Treatment
Being in a clinical trial is different from being treated by your own doctor. In private treatment, the doctor's only aim is to help you. In a clinical trial, the doctors and nurses also want to help you. But the main goal is to find treatments that work for many patients.
Research studies differ from private treatment in three key ways.
1. Trials follow strict guidelines guidelines,
n.pl a set of standards, criteria, or specifications to be used or followed in the performance of certain tasks. . They won't won't
Contraction of will not.
won't will not
won't will "bend the rules" for one patient, and they can't take short cuts. "We know what it takes to do a study right the first time," says Dr. Margaret Margaret, 1930–2002, British princess, second daughter of King George VI and sister of Queen Elizabeth II, b. Glamis, Scotland. In 1960 she married a commoner, the photographer Antony Armstrong-Jones, who was created earl of Snowdon in 1961. Fischl of the University of Miami This article is about the university in Coral Gables, Florida. For the university in Oxford, Ohio, see Miami University.
The University of Miami (also known as Miami of Florida, UM, or just The U . "We have to be strict to get answers we can rely on. Then we can give the right drugs to the right patients more quickly--and save time and money that can be used to test other promising drugs."
2. Trials may not always offer you a treatment that works. In a study, no one knows if a new treatment will help, or how much it will help. You may not get the new drug, or the dose you get may not be what would help you the most. The treatment plan is set up to answer questions about the drug, such as which dose will work best or whether it should be given as a pill or a shot.
3. Science sets a trial's length. You may be in a study longer than you would like. Or it may end sooner than you'd you'd
1. Contraction of you had.
2. Contraction of you would.
you'd you had or you would
you'd have ~would prefer. A trial lasts as long as it needs to for valid results.
There's one more difference that can mean a lot. In private treatment, a patient can only help one person--himself or herself. In a clinical trial, he or she is helping to test new treatments that could bring a longer life and better health to many others.
Clinical Trials: Answers to Common Questions
Questions About ... The Availability of Clinical Trials
What types of drug studies are there for people with HIV?
Three types of drug studies with HIV patients are under way. These include studies of:
* Drugs that may control the virus that causes AIDS. Such drugs may be able to prevent or delay the onset of full-blown full-blown
1. Having blossomed or opened completely: full-blown roses.
2. Fully developed or matured.
Examples: AZT, foscarnet foscarnet /fos·car·net/ (fos-kahr´net) a virostatic agent used as the sodium salt in the treatment of cytomegalovirus retinitis and herpes simplex in immunocompromised patients. , dideoxycytidine dideoxycytidine /di·de·oxy·cy·ti·dine/ (-si´ti-den) a dideoxynucleoside in which the base is cytosine; it is an antiretroviral agent that acts by inhibiting reverse transcriptase and is used in treating acquired immunodeficiency syndrome. , dextran dextran /dex·tran/ (dek´stran) a high-molecular-weight polymer of d-glucose, produced by enzymes on the cell surface of certain lactic acid bacteria. sulfate sulfate, chemical compound containing the sulfate (SO4) radical. Sulfates are salts or esters of sulfuric acid, H2SO4, formed by replacing one or both of the hydrogens with a metal (e.g., sodium) or a radical (e.g., ammonium or ethyl).
* Treatments that may strengthen the immune system immune system
Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. . The AIDS virus weakens the immune system, and leaves the body open to other infections. This approach may "rebuild" the immune system and help the body fight off other infections.
Examples: interieukin-2, alpha-interferon alpha-interferon
A family of glycoproteins that are produced endogenously and prepared commercially for their pharmacologic effects, which include antiviral and antineoplastic activity and immune system regulation.
* Treatments for the infections and cancers that attack AIDS patients. When these infections can be treated, patients have longer, more active lives.
Examples: aerosol aerosol (âr`əsōl,–sŏl): see colloid.
System of tiny liquid or solid particles evenly distributed in a finely divided state through a gas, usually air. pentamidine pentamidine /pen·tam·i·dine/ (pen-tam´i-den) an antiinfective used as the isethionate salt in the treatment of pneumonia, leishmaniasis, and early African trypanosomiasis. to treat pneumocystis pneumonia Pneumocystis Pneumonia Definition
Pneumocystis pneumonia is a lung infection that occurs primarily in people with weakened immune systems-especially people who are HIV-positive. ;
AZT plus interferon interferon (ĭn'tərfēr`ŏn), any of a group of proteins produced by cells in the body in response to an attack by a virus. A cell infected by a virus releases minute amounts of interferons, which attach themselves to neighboring cells, for Kaposi's sarcoma Kaposi's sarcoma (käp`əshē', kəpō`sē), a usually fatal cancer that was considered rare until its appearance in AIDS patients. ; foscarnet for cytomegalovirus infection Cytomegalovirus infection
A common asymptomatic infection caused by cytomegalovirus, which can produce life-threatening illnesses in the immature fetus and in immunologically deficient subjects. .
Can anyone with HIV join a clinical trial?
Each study tests a new treatment on groups of people who all have the exact type of problem doctors think the new drug may help. Lab tests confirm whether a person has the health picture the study is looking for Looking for
In the context of general equities, this describing a buy interest in which a dealer is asked to offer stock, often involving a capital commitment. Antithesis of in touch with. . Only people who match a study's exact needs will be right for that trial.
Why are trials set up in this way? "AIDS is a very broad disease," says Dr. Volberding. "It involves many types of patients and problems. To get results that have clear meaning, we focus on one patient group or one type of problem. For example, certain drugs may only work at one stage of the disease. A drug that helps a person with AIDS may not help a person with HIV but no signs of illness. When we define what we're we're
Contraction of we are.
we're we are looking at very tightly, then we know just how--and who--a new treatment can help."
Where do clinical trials for AIDS take place?
Most trials take place in large medical centers or hospitals. Sometimes private doctors and local clinics also test drugs.
Clinical Trials: Are You Eligible? Referral: Patient finds out about a study from his or her doctor or other source. The patient or doctor contacts the research staff to find out if the study might be open to the patient. Counseling: Research staff explain the purpose of the trial, the risks, and what the patient will be asked to do. Testing: Patient takes a number of tests, such as physical exam, blood work, biopsy, or x-ray. Either: Or: Results: Patient's test Patient's test results meet the results do not meet trial's needs. the trial's needs. Outcome: Patient signs Patient returns to informed consent private doctor or form and enters clinic for care. He the trial. or she may look for other trials. Or: Patient decides not to take part.
Must I live near a clinical trial to take part?
Each trial has its own rules, "Studies often mean many clinic visits," Dr. Fischl notes. "We need to be sure that people who join won't drop out because it's too far or too hard to come once a week."
How can I learn what trials may be open for my problem?
See page 28 for places to call.
How do I find out if I'm eligible for a trial I'd like to join?
The chart on page 8 briefly outlines how patients find out if they fit a trial's profile.
If you want to find out about getting into a trial, try to work with your doctor or AIDS clinic. The process often moves faster when a private doctor talks to a study's doctors about the medical issues. Then your own doctor can explain the fine points to you.
"If you don't fit one trial's needs," notes Debbie Katz Katz , Bernard 1911-2003.
German-born British physiologist. He shared a 1970 Nobel Prize for the study of nerve impulse transmission. , R.N., a special assistant at NIAID, "don't feel that you have 'failed the test.' New trials will continue to open."
Questions About... Benefits and Risks of Trials
What are the benefits of being in a clinical trial?
Doctors and patients highlight five major benefits.
1. Patients have a chance to help others.
"I've never been a social activist," says John, a person with HIV. "But it means a lot to me now to know that I am part of a test that could help many people with HIV. Yes, I have a serious problem. But I'm trying to be part of the solution."
2. Trials offer access to top medical care.
"When I found out I had HIV," says George, "the doctor almost told me to go away, and to come back when I got sicker. In my research study, the doctors and nurses are HIV experts. They give me the most up-to-date care. And the whole staff is warm and caring."
Bill, another patient, adds, "The key thing to me is all the tests we get in the trial. When you have this disease, you can worry about every cough cough, sudden, forceful expiration of air from the lungs caused by an involuntary contraction of the muscles controlling the process of breathing. The cough is a response to some irritating condition such as inflammation or the presence of mucus (sputum) in the or blemish blem·ish
A small circumscribed alteration of the skin considered to be unesthetic but insignificant.
blemish . It really helps my state of mind to know I'm being watched with care."
Dr. Donald Armstrong of Memorial Hospital in New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of talks about the value of the team approach. "Patients in a trial have doctors, nurses, psychologists This list includes notable psychologists and contributors to psychology, some of whom may not have thought of themselves primarily as psychologists but are included here because of their important contributions to the discipline. , social workers, and pharmacists This is a list of notable pharmacists.
3. Joining means taking positive action.
Kevin is a patient who has HIV infection with no symptoms. "From all I read," he says, "it seemed like it was just a matter of time before I became sick. I got into a trial because I felt I had to do something to try to help myself. Otherwise I was letting the disease take control of me."
4. Patients may be among the first to be helped by a new drug.
"When a new drug is proven to work, those in the study are the first to benefit," notes Dr. Volberding. "This chance to be helped is a chance many people are willing to take."
5. Some costs are paid.
"The tests and drugs that relate to a trial are paid for by the study," explains Dr. Armstrong. "At our center we charge only for care that isn't part of the research."
Every study offers some services free of charge. But each has its own policy about what is covered. State agencies and insurance companies also have different policies about what they will pay for. You should get all the facts before you enroll. Page 21 has a list of questions that can help you know what to ask about costs.
What risks might I face in a clinical trial?
Drugs used in clinical trials have already been through much testing in the lab. But when people first take a drug, there are still many "unknowns." Treatment in a trial can carry three major risks.
1. The treatment may not have benefits.
"The reason for clinical trials," Dr. Fischl underlines, "is to find out what will work and what will not. A new treatment may not help anyone. Or, because every person is unique, it may help some people but not all."
2. The treatment may be harmful
Dr. Eyster says, "There is a chance that any drug may cause harm. A main reason for studies is to find out if people will be hurt by taking a new treatment.
"We watch people with great care. But there are always unknowns. Treatment could in fact make a person worse."
3. The drug may have side effects.
"The greatest fear people have," Joan believes, "is side effects. I worried that I'd feel worse from side effects, even if the drug was helping my disease."
Finding out a drug's possible side effects is one of the reasons clinical trials are held. Side effects in AIDS trials often do occur. "When they are serious," says Dr. Eyster, "we can take the patient off that drug, or the patient can decide to leave the study."
One patient talked about the side effects of all the drugs he takes. "I swallow swallow, common name for small perching birds of almost worldwide distribution. There are about 100 species of swallows, including the martins, which belong to the same family. Swallows have long, narrow wings, forked tails, and weak feet. my AZT pills and I get a headache headache
Pain in the upper portion of the head. Episodic tension headaches are the most common, usually causing mild to moderate pain on both sides. They result from sustained contraction of face and neck muscles, often due to fatigue, stress, or frustration. . I take a shot of interferon and my arm aches. I inhale in·hale
1. To breathe in; inspire.
2. To draw something such as smoke or a medicinal mist into the lungs by breathing; inspire. pentamidine and it makes me tired. Sure its a bother. But would I rather give up on the chance to help and maybe be helped? No way."
Questions About ... Clinical Trials and Your Quality of Life
How much of my time will a clinical trial take?
Every trial is different. Its a good idea to find out what the demands will be before you agree to take part.
In general, people visit the clinic more often at first. Later, they don't need to come in as much. Earl says he started by coming in about twice a week. After 6 months, it was once every 2 weeks; now he goes only once a month.
How long does it take once you're there? It varies. But you can count on spending from one to several hours per visit.
Most studies see patients only during normal business hours BUSINESS HOURS. The time of the day during which business is transacted. In respect to the time of presentment and demand of bills and notes, business hours generally range through the whole day down to the hours of rest in the evening, except when the paper is payable it a bank or by a . If you work, you may want to ask about how you can fit clinic visits into your work day. Study nurses may also have other ideas about how to make the visits easier. Ask them what has worked for other people.
When you think about time, don't forget to include travel time. Earl is only half an hour from his clinic by bus. But Maria is 130 miles from her center, a few hours by car.
Will I have to go through a lot of tests ?
The number and kind of tests given vary from study to study. And some people do find all the blood tests a drawback DRAWBACK, com. law. An allowance made by the government to merchants on the reexportation of certain imported goods liable to duties, which, in some cases, consists of the whole; in others, of a part of the duties which had been paid upon the importation. . Yet research studies depend on tests.
"Careful tests and records," says Dr. Armstrong, "are what research is all about. We need the facts to measure patient progress."
Can I still see my own doctor?
Most studies urge people to keep seeing their own doctor, if they have one. "Having HIV doesn't mean I have no other health problems," Linda says. "My own doctor treats these. He also talks back and forth with doctors from the study."
How will treatment affect my daily life?
Each trial has its own treatment plan. John has to take his pills six times a day, including during the night. He has to be careful not to take his tablet See digitizer tablet and tablet computer.
TABLET - A query language.
["Human Factor Comparison of a Procedural and a Non-procedural Query Language", C. Welty et al, ACM Trans Database Sys 6(4):626-649 (Dec 1981)]. after greasy greas·y
adj. greas·i·er, greas·i·est
1. Coated or soiled with grease.
2. Containing grease, especially too much grease: a greasy hamburger.
3. food. Kevin has to keep a daily record of any health problems or changes, no matter how small. He also writes down any non-trial drugs, such as aspirin aspirin, acetyl derivative of salicylic acid (see salicylate) that is used to lower fever, relieve pain, reduce inflammation, and thin the blood. Common conditions treated with aspirin include headache, muscle and joint pain, and the inflammation caused by rheumatic , that he takes.
For some patients, it is hard to remember to take their medicine and keep their records. Others say it becomes second nature.
"My daily life is better because I take AZT," Earl believes. "I am staying well, so life is liveable live·a·ble
Variant of livable.
Adj. 1. liveable - fit or suitable to live in or with; "livable conditions"
Questions About... Ethical issues
I don't want everyone to know I have HIV. If I join a trial will others find out?
"All trials must set up strict systems to protect your privacy as part of the research plan," Dr. Fischl replies. "At Miami, for instance, we use code numbers instead of names for all tests and records. The codes are locked in a safe. We never give out records, unless the patient signs a form that says he agrees."
Dr. Eyster adds that at the Hershey Center, "People only find out who's in a study when the patients themselves talk about taking part."
Each center has its own system. Ask the research team at your center to explain how they will handle your records.
What safeguards protect people who take part in a study?
Five safeguards protect people who take part in drug studies.
1. Informed consent.
"This means we need to explain all about a study before a person agrees to enter," Dr. Volberding says. "We talk about the reasons for the study, risks and benefits that may occur, and what goes on during the trial. The people who want to join sign an informed consent statement. This says that they understand what' s involved and that they agree to enter."
"The doctors and nurses will spend all the time you need to help you understand," comments Roy from New Orleans New Orleans (ôr`lēənz –lənz, ôrlēnz`), city (2006 pop. 187,525), coextensive with Orleans parish, SE La., between the Mississippi River and Lake Pontchartrain, 107 mi (172 km) by water from the river mouth; founded . "My group session lasted almost all day. We asked a lot of questions. But by the end, we knew what we were getting into!"
Page 20 contains a list of questions you will want to ask the doctor or nurse before you decide on a clinical trial.
2. NIAID review of the study.
For the trials NIAID sponsors, experts in and outside NIAID review all study plans. They look at safety issues. And they make sure a trial is well-planned and uses the best methods of science.
3. Local review of a trial.
Before a trial begins, every hospital that takes part has the plans looked at by a special board. The board includes doctors, science experts, and others (such as clergy). They look at whether the promise of success is great enough to let people take the risks involved. They also check plans to protect patient safety.
4. Safety board review of a trial.
Many clinical trials have to show all their data to an outside, watchdog group. This safety board is made up of experts with no ties to the trial. "The board reviews all a trial's data while it is still going on," explains NIAID's Debbie Katz. "They check to be sure that people are not being harmed by the treatment. In the trial that first proved AZT's value, the board stopped the study early. it was already very clear from the data that the drug had helped. With this proof, it would have been unfair to keep the drug from other patients."
5. Patient's right to stop treatment.
"A patient can leave a study at any time, for any reason," Dr. Eyster says. "Doctors also stop any treatment that is causing harm. For example, AZT makes some people very ill, even though others can take it with few problems. When AZT hurts a person, we lower the dose or we stop it."
"When I joined my trial," Kevin adds, "I was worried that I might be hurt by the new drug. But I figured, what did I have to lose? If I started feeling a lot worse, I would leave the trial."
Why do some trials give the new treatment to only some of the patients?
Studies that test new drugs often compare the progress of one group who gets the new treatment with that of a second group who does not. Dr. Eyster explains the reasons.
"To see why we need to compare, say for a moment that we did give each person in a study the new treatment. And say we saw some people improve. How could we be sure that people got better because of the new treatment? They could have improved on their own or for some other reason.
"When we compare, we see that a similar group of people who did not get the new treatment did not get better. Then we can feel sure that the new treatment made the difference."
Patient to Patient
"Don't be afraid of the drugs in trials. They may make you ill at first; and you may wonder why you're doing this to yourself. But half of it is your mental attitude. You have to work with it to make it work."
"I've known too many people who died taking some weird cure' they got from Mexico or somewhere. I've been in a research study for two years, and it isn't always easy. But the treatment makes sense."
"Since I found out I had HIV I've been in two studies. There was a 6-month stretch between them. During that time, I felt very alone, scared, paranoid par·a·noid
Relating to, characteristic of, or affected with paranoia.
One affected with paranoia. ... it was the worst time in my life. Now I know how much being in a trial helps my mental health."
"Being in a trial means making some sacrifices, keeping up your end of the bargain. It's worth it to me. But you should get all the facts before you decide. There's no point in starting it just to drop out."
"How has the trial changed my life? I have HIV with no symptoms. For a while, I put being sick out of my mind. Of course, I was only fooling myself. But now I can't deny that I have a disease. The pills and the tests remind me of it every day."
"You've got to do something. Even if that only means finding out about all your options. You may decide not to join a trial. But you made a choice--you took control."
Almost all NIAID research studies today compare the new treatment with a drug already in use to see which works better. In a few cases, when there is no known drug that helps a problem, a study may compare the new treatment with a look-alike pill that contains no drug (placebo).
"Some people feel that it isn't humane humane
pertaining to the avoidance of infliction of pain, discomfort and harassment; used especially with regard to animals.
humane considerations to give a placebo in a disease like AIDS," Dr. Volberding says. It's easy to understand their feelings. But, in fact, using a placebo can be the most humane choice. Because of its design, the test can be shorter. We find answers we can fully believe in. And fewer people need to be put at risk."
In all placebo studies, clinic staff tell people before they join that there is a chance of getting a look-alike drug. Then it is their choice whether or not to enter that study.
Why can't people in a trial take other drugs that may help them?
Sometimes they can. Each trial and each case is different. Steven, for instance, is taking AZT and interferon in his trial. His private doctor also gives him aerosol pentamidine, with the trial's agreement.
When other drugs are not allowed, its because they could confuse con·fuse
v. con·fused, con·fus·ing, con·fus·es
a. To cause to be unable to think with clarity or act with intelligence or understanding; throw off.
b. the trial's results. "We could see people getting better and think it was due to the test drug," Dr. Armstrong notes. "But maybe the drug they took on their own was the reason.
"At our center, we believe doctors and patients have to talk openly about the other drug' issue," he adds. "Maybe we could have them go on a study where the drug they wanted would be allowed. At least if we know what they're taking, we can be smarter when we look at their results."
Thinking it Over... Is a Clinical Trial Right for Me?
Are you thinking about joining a clinical trial? First, get all the facts you need to make your choice. Then be sure how you feel about the issues. Here is a checklist that can help.
The first part is a list of questions to ask your doctor and/or the staff of the trial you are looking into. The second part is a list of questions to ask yourself.
Questions to Ask the Doctor:
Facts about the study
* What is the purpose of the study?
* Who is running the study?
* Who is paying for the study?
* Who will review the results?
* What treatment(s) may I receive?
* Does the study use a placebo?
* Why do doctors believe that this treatment may work?
* How will the study keep my name and records private?
Risks and benefits
* Does the treatment have any known side effects?
* Are there any other risks?
* How may I be helped by the new treatment?
* What other options for treatment do I have?
* How do the pros and cons pros and cons
the advantages and disadvantages of a situation [Latin pro for + con(tra) against] of my other options compare with those of the study?
What treatment will involve
* How long will the trial last?
* How often will I need to come to the clinic?
* How many times a day will I need to take a drug?
* What other things will I need to do?
* How is the drug given--as a pill, in a shot, or in another way?
* What tests will I need to take?
* Will I be able to see all my test results?
* Who will treat me in the study?
* Will a social worker (or other trained staff) provide support and help me deal with problems?
* Will I see the same doctor or nurse each time?
* Can I keep seeing my private doctor, if I have one?
* Where will I be treated after the study?
* If I take a drug that helps me, can I keep taking it after the study is over?
* What costs will be covered by the trial?
* What other costs can I expect?
* Does insurance usually cover the costs that a study does not pick up?
* What other help with costs is available?
Questions to Ask Yourself:
* Is helping to find better treatments for HIV important to me?
* Can I accept the changes a trial may make in my daily life?
* Am I committed enough to:
-take the drug as often as I should?
-go to the clinic as needed as needed prn. See prn order. ?
-stick with a trial as long as it lasts?
* Am I willing to follow all of a trial's policies?
* Are the pros of taking part greater than the cons?
* Will I have the support of my friends and family?
Terms You May Hear
Clinical trials. A research study in which people take part. A clinical trial tests new drugs and other treatments to see whether they help people get better. The research plan for a study is strict and follows the rules of science. Studies must be careful and thorough to give doctors and patients results they can trust.
Controlled study. A study in which doctors give the new drug being tested to one group of people. This group is often called the treatment group. They also give another drug, or no drug, to a second group of people with the same type of illness. This group is often called the control group. Then they compare the results of the two groups.
If people taking the new drug get better--and people taking the other drug (or no drug) do not--we know that the new drug works. Using a control group lets doctors be sure the new drug, and only the new drug, caused people to improve.
If the new treatment group does not improve more than the control group, we know that the new drug does not work any better than the treatment the control group was taking.
If many people in the treatment group get sicker, and people in the control group do not, we know that the new drug is not safe.
Double blind. A type of study in which neither the patient nor his or her doctor knows which treatment the patient is getting. It may be the new drug being studied. Or, it may be the "control" pill that doctors are using to compare results.
Some studies are "single blind." In these, patients do not know what treatments they are getting but their doctors do.
Why is blinding needed? When people take a pill that they believe will help them, they often see signs that they are getting better--even when they are not. The reverse may also be true. Doctors, too, may read the signs wrongly, because of what they expect to see.
When a study is blinded, no one expects a certain outcome. They see results as they are, with no false ideas to confuse them.
In all blinded studies, treatments are coded for safety. If a drug is harming a patient, the doctor can quickly find out which treatment it is.
Eligibility criteria. Key facts about a person's health that make a patient right, or not right, for a certain research study. Examples of these facts include: a person's age; what symptoms of HIV or other illness he or she has; results of certain lab tests; a person's overall health; and past treatments he or she has had.
To be right for a study, a person's health picture has to match all the study's needs fully.
First, you need to have all the health factors that are listed in the study's research plan (called inclusion criteria
Inclusion criteria are a set of conditions that must be met in order to participate in a clinical trial. ). Each person who takes part will have these same factors, so that doctors can compare like with like.
Second, the research plan lays out some health factors that people who take part in a study cannot have (called exclusion criteria exclusion criteria AIDS Donor exclusion criteria, see there ). Often, this is done for safety. For instance, doctors may know or fear that the new drug will cause people with a certain illness or lab test result to get sicker. It would be wrong to allow them to take that risk.
Both the "must have" and the "can't have" checklists help doctors get clear research results. By working only with people who match these lists, doctors can be more exact about who a new drug will help, not help, or harm.
Informed consent. Each study paid for by NIAID must explain the project to all persons who ask about taking part. You have a right to know how you may be helped, if you may be harmed, or if you may have no change for the better. The research team should also tell you what joining a study will mean to your daily life: what tests you will receive, how often you'll need to come in to the clinic, costs, etc. (see checklist on page 20). After learning all about the study, you will decide whether or not to take part.
If the answer is "no," that's fine.
If the answer is "yes," you will sign a form that says you know the pros and cons of taking part and what the study involves.
Each study tries to do a good job of giving people the facts they need to make a sound choice. But if you are still unclear on any point, keep asking questions. It is your right--and you owe it to yourself to be sure.
Institutional Review Board (IRB IRB
See: Industrial Revenue Bond ). A group of doctors, science experts, clergy, and others who review a research plan. For all studies paid for by NIAID, each hospital doing the research must have an IRB. This board makes sure that the study protects patient safety. They will only approve a study if the benefit it may bring is likely enough and great enough to allow the risks people may face by taking part.
Placebo. A pill or liquid used in research studies that contains no drug (sometimes called a sugar pill). A placebo looks just like the real drug. This way, patients and their doctors in a blinded study don't know who is taking the new drug and who is taking the "no-drug" pill.
For HIV, studies only use a placebo if there is no proven treatment that doctors could use to compare with the new drug. Page 17 talks more about why some HIV studies need to use placebos.
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. study. A study that assigns Individuals to whom property is, will, or may be transferred by conveyance, will, Descent and Distribution, or statute; assignees.
The term assigns is often found in deeds; for example, "heirs, administrators, and assigns to denote the assignable nature of each person by chance to the treatment group or the control group.
Why do studies put people into groups at random? This method keeps a study's results free of bias. For instance, doctors could "stack the deck Stack the Deck is a pricing game on The Price Is Right. Debuting on October 9, 2006, it is played for a car. Gameplay
The contestant is shown seven digits, in the style of playing cards, and five spaces representing the price of the car. " for a study without meaning to. They might assign people to groups based on their ideas about who would be helped most by the new drug, or based on some other point of view.
When the results came in, no one could be sure that the doctors' case-by-case choices didn't affect the outcome in some way. Then no one could be sure that other patients would get the same results from the treatment.
Steps in Drug Testing
The process of finding safe new drugs that work well is complex and includes many lab tests, trying out the drug in animals, and, if it shows promise, testing it in people. To protect patient safety, the U.S. Food and Drug Administration requires that drug testing in people be done in steps or phases. The drug must be found safe and/or effective in each phase before it can move on to the next.
Type of Number of Trial Patients Length Purpose Method Phase 1 20-100 Several To see if drug All patients months is safe get the drug being tested. Phase 2 Up to several Several To test effec- In phases 2 hundred months tiveness and and 3, doct - 2 years short-term tors compare safety results for Phase 3 Several 1-4 years To test two groups; hundred to safety, effec- the first gets several tiveness the drug thousand dosage level being tested; the second gets another drug, or no drug.
How to Find Out More
There are several places you can go to find out more about AIDS and AIDS drug trials.
* Your doctor. This is the place to start to learn about trials in your area.
* AIDS Clinical Trials information Service (ACTIS). Staff will tell you about trials for AIDS patients and others infected in·fect
tr.v. in·fect·ed, in·fect·ing, in·fects
1. To contaminate with a pathogenic microorganism or agent.
2. To communicate a pathogen or disease to.
3. To invade and produce infection in. with HIV. You can ask for a list of new drugs being tested, where the trials are, and who is doing the studies. English and Spanish Spanish, river, c.150 mi (240 km) long, issuing from Spanish Lake, S Ont., Canada, NW of Sudbury, and flowing generally S through Biskotasi and Agnew lakes to Lake Huron opposite Manitoulin island. There are several hydroelectric stations on the river. are spoken. Call toll-free 1-800-TRIALS-A. Lines are open Monday through Friday 9:00 a.m. to 7:00 p.m. eastern time.
* The National AIDS Hotline 1. (company) Hotline - Hotline Communications Ltd..
2. (messaging) Hotline - Hotline Connect. (sponsored by the Centers for Disease Control). The hotline can give you basic facts about AIDS as well as tell you about AIDS support groups, clinics, and other services across the country. Call toll-free 1-800-342-AIDS. Spanish-speaking callers can dial 1-800-344-SIDA (7432). For deaf access, call 1-800-AIDS-TTY (243-7889). Lines are open 7 days a week, 24 hours a day.
* The National AIDS information Clearinghouse clearinghouse
Institution established by firms engaged in similar activities to enable them to offset transactions with one another in order to limit payment settlements to net balances. (from the Centers for Disease Control) is primarily for health care and other professionals. Staff can tell you about AIDS organizations and materials they produce. English and Spanish are spoken. Call (301) 762-5111 (this is not a toll-free call).
* AIDS/HIV Experimental Treatment Directory, a booklet that is brought up to date four times a year, describes drugs that are being tested and tells where the tests are going on. Call the American Foundation for AIDS Research (AmFAR), (212) 719-0033.