Should I Join an AIDS Drug Trial?
A handbook from the AIDS Treatment Data Network
Table of Contents:
Ways to Treat HIV
There are now 13 anti-HIV drugs available by prescription. They are usually prescribed as part of a three or four drug combination. Anti-HIV drug combinations are referred to as HAART , which stands for Highly Active Antiretroviral Therapy. Clinical trials have shown that HAART can work well in people who have been diagnosed with AIDS, as well as people who have HIV-related Symptoms.
About T4 cells and Viral Load
HIV causes illness by damaging the immune system. Measuring your T4 cell count gives an idea of how the immune system is doing, and can also help you decide if and when HIV treatment is needed. The T4 is also called the CD4. The other important test is called the viral load test. The viral load test measures the amount of HIV in a blood sample. Measuring both the T4 cell count and the viral load can help you decide if you should start treatment.
What is the Goal of HIV Treatment?
The goal of anti-HIV treatment is to reduce the amount of HIV in the body as much as possible for as long as possible. viral load tests are also used to measure how well anti-HIV treatments are lowering the amount of HIV in the body. Treatment should also increase your T4 cell count, and may help with any Symptoms of HIV disease.
When Should I Start Treatment?
You don't necessarily need to start HIV treatment just because you're HIV positive. If you don't have Symptoms of HIV, or if you have a low viral load count, it might be better to wait to start treatment. One argument against waiting is that HIV may be causing ongoing damage to your immune system. If you are HIV-positive, getting regular checkups and bloodwork done is strongly recommended to help you decide if you need treatment.
How Can I get Treatment?
You can get approved HIV treatments from your doctor. There are different kinds of programs, such as Medicaid, AIDS Drug Assistance Program (ADAP), and pharmaceutical company assistance programs that can help you to pay for these treatments if you are uninsured or underinsured. A treatment that is not yet approved may be available through a clinical trial. Some of the treatments that are being studied in clinical trials are also available through special programs called expanded access programs.
What is a Clinical Trial?
A clinical trial is a carefully controlled experiment in which people take a drug to find out if it works, and if it is safe. In a clinical trial, one or more different drugs or combinations of drugs are compared to each other. In the past, when there weren't many treatments for HIV, a clinical trial often gave one group of people an experimental drug, while the other group got nothing (or a dummy pill called a placebo). Now, however, many clinical trials are looking at different combinations of approved and experimental drugs. Approved drugs are often used in clinical trials. This handbook describes the possible benefits of joining a clinical trial, as well as the possible risks.
What Treatments are being studied?
Some clinical trials are trying to find out if taking an experimental drug along with an approved HIV treatment combination is safe and effective. Other trials compare one experimental drug to another. There are trials for people who have already tried many different drug combinations. There are also clinical trials that are looking at ways to prevent and treat opportunistic infections, cancers and other conditions.
Why are clinical trials done?
Drug trials are done to find out which treatments work, and which ones don't. If drugs are sold without being tested, the only information about the drug will come from unproven stories, or from the company that makes the drug. Drugs might be advertised and sold without proof that they work or are safe. Now that there are approved drugs for HIV, a clinical trial might be done to find out if there are easier ways to take the drug, or to find treatments for side effects of approved drugs.
How do Clinical Trials Work?
If a drug company wants to study a treatment, they must submit a proposal to The Food and Drug Administration (FDA). A clinical trial must follow well-established guidelines for testing drugs in human beings. Once the FDA approves the plan for the trial, which is called a protocol, the trial can start. Every drug sold in the US must be approved by The FDA. The FDA reviews the results of clinical trials to determine if the drug is safe and effective.
How do I find a trial?
Organizations like The Network maintain up-to-date information about different types of trials and treatment programs. The toll-free Network number for New York State residents is 1-800-734-7104. You can also call the national information number for the AIDS Clinical Trials Information Service (ACTIS) at 1-800-TRIALSA.
About Clinical Trials
After a drug has been tested in the lab and in animals, it is tested in people. You might not know exactly what drugs you're getting in a clinical trial. It depends on what treatments are already approved for your condition, and how much is already known about the treatments being tested in the clinical trial.
Is the Treatment Safe?
There are three types, or phases, of trials that are done with people, although sometimes phases are combined. In a Phase I trial everyone usually gets some amount of a drug, but since researchers need to know how the body reacts to the treatment, and how much should be given, people are often given different amounts, or doses. Phase I trials are short, usually less than 2 or 3 months long, and usually involve under a hundred people. Because a treatment is being tested for the first time ever in people, this type of clinical trial is usually riskier than the other phases.
Does the Treatment work?
If a Phase I trial finds that the drug is safe enough to continue looking at, a Phase II trial will be done. In a Phase II trial more people are given the drug to see if it works, and to study the side effects more carefully. Phase II trials can last from a few months to a few years. Sometimes trials combine Phase I and Phase II to speed up the process, but there are still risks that go along with possible benefits. A drug could be approved after a Phase II trial if the drug company shows that the drug is both safe to take, and that it works for most people. The drug company is then expected to conduct the Phase III trials after the drug is already approved.
What if many people take the treatment?
In a Phase III trial, many people, sometimes thousands, are given the drug to see how well it works. Researchers look for rare side effects which are typically only seen in a few people. Sometimes phases are combined, and you will see a trial described as Phase I/II or Phase II/III. In this type of trial you'll know what drug you're taking, and how much. In a Phase II or Phase III trial, you probably won't know what drug combination or dose of the drugs you are taking.
What is a "Controlled" Trial?
Most clinical trials are controlled. The group taking an approved treatment in a clinical trial is called the control group. Researchers compare the other groups in the trial to the control group to see if one group does better or worse than the other. People in a controlled trials are usually divided at random, or by chance, into one of the groups. If no one, not even the people running the trial, knows who is taking what until the trial is over it is called a Double-Blind study. If everyone knows who is taking what, it is called an Open-Label study. If there is no approved treatment for your condition, you may end up in a group of the trial that gets a placebo.
What is a Placebo?
A placebo is a treatment that is made to look like one of the treatments that is being studied in a trial. A placebo is meant to look like an actual, or real treatment being tested, but it's not. A placebo is made up of chemicals or other substances that don't have any effect at all. If the experimental drug is a pill, the placebo will be a pill. If the experimental drug is a shot, the placebo will be a shot.
If the people in a trial already strongly believe that what they are getting in a trial works, they may get better just because of their positive attitude. This is called the placebo effect. This can also happen if people strongly believe that the treatment they are getting doesn't work. People get worse because they think that's what should happen. The treatment may not have anything to do with it.
For example, in one trial that tested a drug to treat diarrhea, half of the people who were given shots of an experimental drug got better. But, half of the people in the same trial that got placebo shots also got better. This means that the drug didn't really work. In this case, using a placebo helped researchers to find out that there was no reason for people to give themselves the shots every day, because they didn't help any more than doing nothing. Because a treatment can be difficult to take, cause side effects, and make life more difficult to deal with, researchers use placebos to make sure a treatment really works before it is approved for prescription.
Will I get a placebo?
Placebos are used in some trials, but less often than they used to be in the past. You might get a placebo if an experimental drug is involved in the study. For example, if researchers are trying to see if adding an experimental drug to an already approved combination of drugs works better, one group gets the approved treatments and the experimental drug, while the other group gets the approved drugs along with a placebo. If you are thinking of being part of a trial in which you might be given a placebo, ask how long people will be given a placebo, how it will be given, and if you will be able to get the experimental drug after the trial is over. This does not mean that the new drug will work, but if it does you'll know that you'll be able to get it.
Why would I want to be in a trial?
Deciding to join a trial can be difficult. There are always risks involved. Carefully weigh the risks and benefits of any trial you are thinking about joining. Discuss the trial with people who you trust to give you advice about what would be best for you and your health. Speak with your doctor and other health care providers, and with people who have been involved in clinical trials themselves. Find out if there are other at other places, or trials of other drugs that might be better for your situation.
Reasons to join a trial:
Reasons not to join a trial:
- There may be no drug approved to treat your condition, and you might be given a drug that you could not get anywhere else.
- You may not be able to take the drugs already approved for your condition.
- You are interested in helping with research that will lead to finding better treatments for AIDS.
- You want to be closely watched for the possible side effects or unexpected reactions of a treatment.
- You want to get a new drug that turns out to be a more effective or easier to take treatment.
- You might get a treatment for the side effects of another treatment you are already taking.
- You may have to stop taking other medications that may be helping you.
- Your condition may get worse.
- The treatments in the trial may have side effects, or be unsafe.
- If other treatments are approved they may not work as well, or at all, because of the treatments you took in a clinical trial.
- You don't have the energy, time or interest to participate in the trial.
Being in a Clinical Trial
Every trial has strict rules about who can join. The requirements of a trial are called Inclusion and Exclusion Criteria. Examples of inclusion criteria are having a T4 cell count of over 200 or being older than 13. Exclusion criteria are things that will keep you out of a trial, such as medications that you can't take while you are on the trial.
When you find a trial that interests you, the first step is to call the trial site. The coordinator will ask you questions. If you meet the basic requirements of the trial, they will arrange for you to visit the site for an interview. During the interview, you'll be asked detailed questions about your health. A medical exam and some blood tests are also usually done.
What's it like to be in a Trial?
Every trial is different, so it's important to learn exactly what a trial requires before you join it. Everything you have to do while you're in the trial should be carefully explained to you. For example, you may be asked to write down information at home about your daily activities, or you may be told not to eat certain foods. If you think you might need help doing any of these things, ask for it. You should also know the reasons why you might be asked to leave the trial.
Do I need my own doctor?
Yes. Joining a clinical trial is not the same as having your own doctor. Clinical trials are not designed to provide people with treatment, so it's important that you have a regular doctor or clinic for regular checkups and lab tests while you are in the trial.
How are the drugs given?
A drug may be given in one of several ways. In some trials, different drugs are given in different ways. Here are some of the ways a drug might be given:
- Oral - A pill or liquid that you swallow by mouth
- Intramuscular - injected into a muscle
- Intravenous - injected into a vein
- Subcutaneous - injected under the skin
- Inhaled - a spray that you breathe in
- Topical - a cream or patch you place on your skin
- Sometimes a treatment involves a procedure, such as being exposed to light from a machine.
When do I take the treatments?
In some trials you will take the treatments at home. In other trials, you will have to stay overnight or for longer while you are in the trial. You will be told exactly when and how to take the treatments in a trial. You should get a written description of what each drug looks like, and how often you are supposed to take it. Ask the study coordinator to go over your daily schedule with you, so you remember how many of each pills you are supposed to take, and what you can or can't eat. If you think you may forget how you are supposed to take something, make sure the study coordinator knows this.
How often do I go to the site?
You may have to visit the site as little as once a month or as often as five times a week. At first, there may be many medical checkups to see what the drug is doing to you. Later in the trial there will usually be fewer checkups. Ask for a schedule.
Will it cost me anything?
The drugs used in trials are usually given free, but this is not always the case. Many trial sites will want your insurance company or Medicaid to pay for drugs or tests. You may be billed for being screened for a trial. If you don't want your insurance company to know you're in a clinical trial, talk about this with the people running the trial before you give them information about your health insurance. If you don't have Medicaid or insurance, the site may agree to pay for everything or they may want you to pay. Check with different sites to see what the costs will be before you agree to an interview. Get the name and phone number of anyone you talk to, and keep records.
What Support Will I Get?
Being in a clinical trial involves time, energy and expenses. You may have to take time off from work, or come up with extra money for transportation to take part in a trial. Ask the study coordinator what type of support is available to you while you are in the trial. For example, many trials will cover carfare or public transportation costs, and give you meal tickets or provide food. Some sites will connect you with other services you need.
Will I Get Paid?
Some research sites pay participants for being in their trial. They provide a stipend every time you visit the site, or pay you when you have certain tests done. Not all trials take place at every research site, but if the same trial is open at a number of different places, decide which site best meets your needs. There are also trials that give cash to people if they join, but make sure you are fully informed about what is expected of you. Treatment for possible side effects may not be covered by your insurance company.
Who's in charge of the trial?
The person in charge of the clinical trial at each site is called the principal investigator. He or she is usually a doctor, although they could be a nurse or other clinical researcher. The study coordinator, usually an experienced and very helpful nurse, is the person who you will deal with most of the time. There may be a team of doctors and nurses who do the medical exams and the blood tests, etc. The protocol chair is a doctor who helps plan the trial, and who is in charge of all the different sites. If you don't qualify for a trial or if you're asked to leave because of one bad blood test, you can ask the protocol chair for an exception.
What if I'm Pregnant?
For pregnant women with HIV, decisions about the best anti-HIV treatment to use should be based on the health of the mother. Because the chances of anti-HIV drugs harming the fetus are greatest during the first trimester of pregnancy, it may be a good idea to wait until after the first trimester before starting anti-HIV treatment, if this is possible.
For a woman who's already on combination anti-HIV treatment but who has a low risk of disease progression, consideration could be given to stopping anti-HIV treatment for the first trimester ofbb pregnancy. If treatment is stopped, all anti-HIV drugs should be stopped at once to lower the chance of drug resistance. There is little information about the safety of any anti-HIV drugs in pregnancy apart from AZT. AZT has been shown to reduce the chances of transmitting HIV from mother to baby by about two-thirds.
Health & Safety Conerns: Do I have to leave my doctor?
No. If a trial site wants you to leave your doctor and be the only place you go for health care, you will want to carefully consider what effect this will have on you. Going to a doctor in one place, and a trial site somewhere else could take more time and energy, but you should always have a doctor whose first priority is your health, not the success of a clinical trial. Ask that the people who run the clinical trial communicate with your doctor on an ongoing basis. Make sure that you and your doctor get copies of all blood tests done while you are taking part in a trial, and that you discuss any side effects you experience with your doctor.
What if I get sick while I'm in the trial?
If your health gets worse while you're in the trial, the people running the trial will try to find out if the drug is making you sick or if you're sick for some other reason. Keep your doctor informed about everything you are experiencing.
Some drugs have side effects, like headaches or stomachaches. Some drugs can lead to serious illness or death. If you get sick because of the drug, tell the people running the trial. You may either be taken off the drug or be given a different amount. If the trial is comparing two drugs, you may be offered the other drug. Discuss your options with your doctor.
If you get sick, but not because of the drug, you may have to leave the trial. It's important to get the phone number of a doctor or nurse involved with the trial who you can call 24 hours a day, in case you get sick in the middle of the night. Because the drugs in trials are experimental, a doctor in an emergency room may not know what to do if the drug makes you sick. This is another reason why your doctor should always know everything that is going on in a clinical trial. Ask both your doctor and the study coordinator how you can be prepared if this happens.
What is Informed Consent?
At the first visit you will be asked to give your informed consent to join the trial. Informed Consent means that after being informed of all the possible risks and benefits of the trial, you consent (agree) to join. The Informed Consent Form explains the rules of the trial in plain terms. It should be in your language. Otherwise, the trial site should provide an interpreter to explain it to you.
Be sure that you understand and agree with everything about the trial before you sign this form. Keep a copy for yourself. Even if you sign, you can still leave the trial whenever you want and for any reason. If a child is joining a trial, the parent or guardian will be asked to sign the form, stating that all the risks and benefits for the child are understood. Joining a clinical trial means that you agree to follow the rules of the trial. The rules of the trial are called a protocol, which explains exactly how the trial will be run. If you don't feel comfortable with the rules - like not being able to make all the appointments, or going to a clinic where the waiting room is full of sick people - talk to the people running the trial.
Who protects me when I'm on a trial?
Every institution that conducts medical research involving people is required by the federal government to have an Institutional Review Board (IRB). The IRB is a group of people from various professions who are responsible for protecting the rights of people in a trial. The IRB must approve any trial being done at that institution, and reviews the trial every few months.
The IRB can stop a trial that doesn't do what it promised or one that exposes people to harm. You can complain to the IRB if you have a problem while in a trial. The people running the trial will tell you how to contact the IRB. You can also complain to the people in charge of the trial, to the Patient Representative at the trial site, or to an organization that advocates for people with AIDS.
What about my Medical Care?
Make sure you know how to get medical care at all times, including after you leave the trial. It's important to go to your doctor for regular checkups. Ask if the trial site will help you find a doctor if you don't already have one. Find out who you can call for help 24 hours a day if you get sick. Ask ahead of time just in case it happens. The trial site may agree to provide you with medical care once the trial is over, but you should discuss this with the study coordinator beforehand. Continuing medical care may not be possible.
Will I get the Test Results?
Sometimes, researchers are not permitted to look at the results of blood tests until everyone in the trial has reached a certain point in the trial. If this is the case, the protocol for the trial will state when the results of such tests can be looked at, and when you can see them as well.
How do I leave the trial?
You can choose to leave the trial at any time, and this should not affect the quality of care you get at the hospital or clinic in the future. If you get sick because of the drug and are asked to leave the trial, the people running the trial should make sure your medical needs are taken care of, but they might not pay for it.
What happens when the trial ends?
When a trial ends, you will have an "exit interview." If you don't know what treatment you are taking, you will be told during this interview. If the trial ends early because the drug didn't work or was too dangerous, you should be told this. Sometimes the Institutional Review Board (IRB), which is responsible for overseeing the trial and protecting the participants, may decide to change a trial because of data gathered so far. If unacceptable side effects are observed, the trial itself may be stopped.
Can I get the drug if the trial ends?
You may be able to continue to get the drug after the trial ends, but there is no guarantee of this. Sometimes, only enough of the drug is made for the trial, and the drug company decides not to make more. Trials sometimes promise people drugs when the trial ends, but in the past, people haven't always been able to get them.
Other Ways to Get Treatments
Some drugs are available before the FDA has approved them for prescription. This is called Expanded Access. Expanded Access programs are usually for people who can't join a clinical trial, although sometimes the requirements for programs of this type are flexible. If, for example, there are only two anti-HIV drugs that you haven't already taken, and you need a third one to make a treatment combination that has a good chance to work for you, you may be able to get your third drug through an expanded access program.
Although the drugs on expanded access have not been shown to be safe and effective, there is reason to hope that further study will show that they are. The reason they are being made available this way is to give people with fewer treatment options - those for whom one or more protease inhibitors, for example, are not working - the opportunity to try something new that might work for them. In some cases, an expanded access program may be give you different doses of a drug, just like in a clinical trial.
Expanded Access drugs are almost always available for free, but you may have to pay for required lab tests and physical exams. Your doctor is required to submit a request to the drug company that is studying the expanded access drug, although this may only require a one-page form. Your doctor will also need to report on your response to the drug, including lab tests and possible side effects, but most doctors report that this is a simple process.
In the past, experimental drugs have also been made available through Compassionate Use programs. Compassionate use is now usually referred to as a Treatment IND protocol. This type of program usually requires that you are very sick, and have no other treatment options. Because most experimental drugs are available through expanded access programs, this type of program is not as common. Whether or not you are able to get a drug through a Treatment IND Protocol is decided on a case by case basis by the company that makes the drug.
The Network has a complete list of the drugs that are available from drug companies and through programs for people who cannot be part of a drug trial. Call (800) 734-7104 for information on these drugs and treatment programs. It is possible that a clinical trial of a new drug may provide a similar or better option, so if you are able to participate in a clinical trial give us a call to discuss what clinical trials or Expanded Access program you are eligible for.
What about alternative or complementary treatments?
People with HIV sometimes use alternative or complementary treatments, such as herbal preparations and supplements, in addition to whatever other treatments they are taking. Few things that are referred to as alternative treatments have been studied in clinical trials, so the FDA has not reviewed them to determine that they are safe and effective. It is possible that an alternative or complementary treatment will not combine well with other treatments that you are taking. Any treatment has the potential to cause an allergic reaction or side effects, so be sure to find out everything you can about anything you take. Discuss what you are taking with your doctor, so he or she can help work out if there are any possible bad reactions that could occur.
It is against the law to sell a drug if it has not been approved by the FDA. However, it is legal to sell many alternative and complementary treatments as long as no claims are made that they are proven treatments for any specific medical condition. An insurance company, or a government health care insurance program such as Medicaid, however, usually will not pay for anything that has not been approved as safe and effective by the FDA.
Some alternative treatments are considered safe because it is unlikely that they could cause any bad reactions or side effects. Things like massage therapy, acupuncture, or Yoga, for example, probably poses little risk, but check with your doctor just to be sure. Check with The Network for clinical trials or research studies that are looking at alternative or complementary treatments.
What if I can't get into a program?
If you are kept out of a clinical trial or expanded access program because of your race, religion, ethnicity, national origin, sex, age, sexual orientation, hemophilia, or history of drug use, you can file a discrimination complaint with a local Human Rights Agency. You should also contact several organizations that advocate for the rights and needs of people with AIDS and their families.
What Questions Should I Ask?
These questions are meant to help you decide what treatments might be a good choice, and what answers you should get before you make any decisions. Although these questions focus on clinical trials, they can also be used when making decisions about any treatment combination.
You have the right to have all your questions answered. Some should be answered in the Informed Consent Form which the study coordinator will go over with you. Go over these questions with your doctor or other health care providers. Feel free to ask any other questions about anything that concerns you.
Don't feel you are asking too many questions or taking up too much time. While taking part in the trial may prove to be of benefit to you, that is yet to be proven. Clinical trials need participants like you to find out if the treatment works. You are a volunteer who deserves consideration of your concerns.
Some questions can't always be answered, such as the long term side effects of a new drug or a drug combination. Clinical trials are conducted to find out the answers to questions such as these. The trial coordinator will tell you what might happen, but may also have to say they just don't know yet. You will have to decide if you are willing to take the risks that a trial involves.
The more you are informed about available treatments, the better able you will be to make treatment decisions. Contact The Network at (800) 734-7104 for more information about clinical trials.
It is a good idea to write down the answers to the questions so that you can go over them and think about them later. You may want to have a friend, or a member of your case management team with you who can remind you of questions or write down the answers for you. The case management team at The Network provides treatment information, counseling and adherence support to New York City residents enrolled in the case management program. Contact The Network at (800) 734-7104 for more information.
- What is the name of this trial?
- What kind of trial is it? Phase I? Placebo-controlled?
- Do I need to be in the hospital to be in this trial?
- For how long?
- How often must I visit the site?
- What will happen on these visits?
- How long will each visit take?
- Is the trial being conducted at any other locations?
- Is there a location easier for me to get to?
- Is there a site that has Spanish-speaking counselors?
- Is child care available at the site?
- Are there free lab tests or exams at the site?
- Do I have to do anything while at home?
- Are there things I cannot do during the trial?
- Is this drug available outside of this trial?
- If so, where and how can I get it?
- When do I start the trial?
- How long will the trial last?
- What are the immediate side effects of this drug?
- What are the long term effects of my using this drug?
- What if I have to miss a visit or forget to take the drug?
- How will I be helped to deal with side effects?
- What type of drug is being tested?
- How often must the drug be taken?
- How will the drug be given in this trial? Pills? By shot?
- Do I know what each drug looks like?
- Must the drug be taken in the hospital?
- Do I have to take the drug at the trial site?
- Can I take the drug at home?
- How will taking the drug affect my day-to-day life?
- Has this drug been used before?
- For what conditions?
- What were the results?
- What other drugs are being used for this condition?
- How does the trial drug compare in safety and success?
- What is the evidence that this one works?
- What tests will be given before I start?
- Will these tests cost anything?
- Will I get the results of these tests?
- What tests will be given during the trial?
- Will I get the results of these tests? When?
- How often will other tests be done?
- How often will the researchers tell me how I am doing?
- Is this trial confidential?
- Will anyone know about my health condition?
- How will information be coded to protect my privacy?
- Do the consent papers describe all of the risks and benefits?
- What written information will I be given?
- How often will the IRB review the trial?
- How will I be informed of any changes?
- What if the trial changes significantly?
- Will I be put into another trial?
- Will I receive an updated Informed Consent Form to sign?
- Do I need health insurance?
- Do I need to have my own doctor to get into the trial?
- What emergency room can I go to?
- Who pays for medical care if I get sick from the drug?
- Do I have to pay for lab tests or other things?
- Will I be given any money for participating in the trial?
- Will I be given carfare for traveling to and from the site?
- Is childcare money available?
- Will the sponsors of the drug supply it to me free?
- What happens when the drug is available by prescription?
- Will treatment be available to me even if I leave?
- Can I take the drug on an empty stomach? With food?
- Are there any special foods that I need to eat?
- If I am already on a special diet, may I continue?
- Is there anything I shouldn't eat?
- Can I take nonprescription drugs?
- Are aspirin, cold tablets or cough syrup okay?
- Can I use prescription drugs while I am in this trial?
- Can I take other experimental drugs?
- Can I take drugs to prevent or treat opportunistic infections?
- Can I take drugs to prevent or treat other illnesses I may get?
- Pain medications?
- Can I drink alcohol?
- Are there any known interactions with drugs I take on a recreational basis? Cocaine? Heroin? X? K? Others?
- Will taking these during the trial disqualify me?
- What type of contraceptives can I use?
- Do I have to use contraceptives?
- Are contraceptives permitted or monitored?
- Are pregnant women allowed in the trial?
- What if my condition gets worse while I am on the drug?
- Will I be taken out of the trial?
- If I'm on placebo, can I get the drug if my condition worsens?
- Can I take the drug once the trial is over?
- Even if the trial was declared a failure?
- How is the success of this trial defined by the protocol?
- How will decisions about stopping the trial be made?
- How is failure defined in the protocol?
- Will this be done even if I decide to leave the trial?
- Will my health be checked after I stop taking the drug?
- Will there be long-term follow-up on how I am doing?
- Will this be done even if I leave the trial before it is over?
- What if the entire trial is stopped early?
- How can I find out the results of the trial?
- Will I be able to participate in future trials of this drug?
- Will I receive the results of future trials using this drug?
A substance that stops or suppresses the activity of a retrovirus such as HIV. AZT, ddC and ddI are examples of antiretroviral drugs.
Clinical Trial: A test of a new or experimental drug in people. Also called drug trials or studies.
A trial in which experimental drugs are tested against each other or against an approved drug.
Trials in which one group gets the experimental drug and another group gets either a placebo or an approved drug as part of the control group of the study.
A trial that uses different amounts of the same drug. Sometimes the drug is tested against a placebo.
In this type of trial a few people take a small amount of the drug. If it doesn't hurt them, a few more take a larger amount. This continues until the researchers find the largest amount of the drug that can be taken without immediate harm.
A type of clinical trial in which people are divided into different groups. One group takes the experimental drug and other groups take different doses, the standard therapy, or a placebo. Neither the researchers nor the people in the trial know who is taking what until the trial is over.
Programs designed to make experimental drugs available on a wide basis to people who do not qualify for the clinical trials or who live too far from a trial site.
Highly active antiretroviral therapy. Refers to a combination of anti-HIV drugs.
Investigational New Drug. This is the name given to an experimental drug after the FDA agrees that it can be tested in people.
The name given to the process during which a person weighs the known and possible risks and benefits of a trial, then agrees voluntarily to participate. When someone agrees to be in a trial, they sign an agreement called an Informed Consent Form.
The medical or other reasons why a person may or may not be allowed to enter a trial. For example, some trials do not allow pregnant women to join, others do not allow people to take certain drugs, and others exclude people with certain illnesses.
Institutional Review Board. Every institution or hospital that conducts research involving human subjects must have an IRB that approves and periodically reviews the research. The IRB protect the rights of the people in the trial, determines who can participate in the trial, and whether the trial is ethical.
If you haven't taken any HIV treatments before, you are said to be treatment naive.
A type of clinical trial in which researchers and participants know who is taking the experimental drug or the treatment being given.
A substance that has no effect on the body that is given to onegroup in a placebo-controlled trial. Often referred to as a sugar pill.
A detailed plan stating a clinical trial's purpose, drug dosages, length of treatment, how the drug is given, and inclusion/exclusion criteria.
A trial in which people are assigned to one of two or more treatments by chance. Usually a computer is used to be sure that everyone has the same chance of getting on any given part of the trial.
a clinical trial, often open-label, for people who have failed several many different approved HIV treatment combinations.
All prescription drugs can sometimes have unwanted effects, known as side effects. Laboratory testing (bloodwork) is one of the methods used to monitor for potential side effects.
Describes some of the possible side effects of a drug. Also indicates how much of a drug can safely be taken.
If you have taken some or many different HIV drugs treatments, you are said to be treatment experienced. If you're doing well with what you're on, you are stable.
An FDA program that makes experimental drugs available to seriously ill people. Drug companies may charge for the drug, although most don't.
means the amount of HIV in the blood sample is too low to be measured, but it doesn't mean that there is no HIV there at all.
viral load test
The viral load test measures the amount of HIV in a blood sample.
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About The Network
The Network is an independent, nationwide, not-for profit organization. We help men, women and children to obtain medical care, approved and experimental treatments, social support services, and public and industry sponsored treatment programs. We also provide English and Spanish language information, counseling and referrals by phone, fax, E-mail, printed materials, and at public gatherings. We do not sell, endorse, promote or recommend any approved or experimental drug, treatment, therapy or procedure. There is no charge for any of our services or materials, including this handbook. We gratefully accept and recognize donations from corporations, foundations, government, agencies and individuals.
About This Handbook
The information in this publication is not meant to replace the advice or care of a medical professional. Always discuss your treatment options with a trained health care provider. We don't manufacture, test, sell, advertise, or endorse any of these drugs or therapies.
Material for this handbook comes from many different sources. We are grateful to The New York State Department of Health AIDS Institute for their support of our work. This handbook was written by Ken Fornataro and Richard Jefferys, with lots of assistance and support from Maximo Sepulveda, Lizzie Nevarez, Richard Walker, Joel Beard, Juan Sosa, Germán Esqueda, Robert Farber, Frank Niro, Mark Harrington, Carlos Mascarenhas, Eleanor Mitchell, Luis Hernandez, Ken Golden, Felix Cruz, Paul Cothran, Pamela Reeves, Hector Perez, and many other Network friends and supporters. Some of the individuals mentioned above are no longer with us in body, but always in spirit.
This publication was supported by grant number BRH890015-08-0 from the U.S. Health Resources and Services Administration (HRSA). This grant is funded through Title I of the Ryan White Comprehensive AIDS Resources Emergency Act of 1990, as amended by the Ryan White CARE Act Amendments of 1996, through the New York City Department of Health to the Medical and health Research Association of New York City, Inc. Its contents are solely the responsibility of the AIDS Treatment Data Network, Inc., and do not necessarily represent the official views of the funders.
Information published courtesy of Network home page
This article was last modified in: 06/18/2012