Transcript HIV Clinical Trials Patricia Farrell, MPH, ND, PhC, RN HIV Clinical

HIV Clinical Trials
Janice Price, M.Ed, RN
HIV Clinical Research Program Coordinator
Swedish Medical Center
Seattle, WA USA
HIV Positive? Take Control
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Find a provider you trust
Build a support system
Learn about your disease
Learn about your treatment options
– No Treatment
– Treatment by Prescription
– Clinical Trials
What is a Clinical Drug Trial?
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Drug trials are also called clinical trials
or studies.
A trial is a controlled experiment in
which people take a drug to find out if it
works and if it is safe.
It is necessary to prove that a drug is
safe and effective before it can be
legally sold in most countries, including
the US.
HIV Clinical Drug Trials
Who are they for?
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People who have never been treated for
their HIV.
People who have been treated before
but need to change their medications.
People with opportunistic infections.
People who need extra guidance with
taking their medications.
People who want to contribute to the
understanding of HIV treatment.
Types of Drug Trials
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Phase I: Is the drug safe?
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Phase II: What dose is best and does
it look like it will work?
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Phase III: How safe and effective is the
drug in a large number of people?
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Phase IV: Studies after a drug is
approved.
Controlled Trials
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People are placed, at random, into one
or more groups in the study.
One group will get the investigational
drug (the one being studied), and one
will get the already-approved current
standard treatment.
Open label trials.
Double blind trials.
Open Label Trials
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Each person knows exactly what drugs
they are getting.
Randomization into groups often
occurs. The investigator usually does
not have control over this process.
The study personnel know what drugs
everyone is getting.
There are no secrets here.
Double-Blind Trials
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The most scientific way to run a study.
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No one knows exactly what drugs the
participants are getting, neither the
study personnel nor the doctors.
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Can be placebo-controlled. Make sure
to ask detailed questions about
treatment groups.
What is a Placebo?
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A placebo is a “dummy drug” made to
look exactly like the real drug.
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Placebos are used along with the real
drug to keep study participants (and the
doctors and nurses) from knowing what
drug they are taking.
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This removes ‘bias’.
Placebo-Controlled Trial
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Everyone receives a treatment. (It is
unethical to not give treatment for a
disease that already has some type of
treatment approved for it.) Some will get
the new drug, some will get a drug already
in use (Standard of Care). No one will
know who gets what if the trial is blinded.
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Example: Active Drug A + Placebo of Drug
B vs. Placebo of Drug A + Active Drug B.
Reasons to Join a Trial
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There may be no drug approved for
your condition, and you might be given
a drug you can’t get elsewhere.
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You might not be able to take one of the
approved drugs because of the side
effects.
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You continue to get sick, even though
you’re taking an approved drug.
Reasons to Join a Trial
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You are interested in helping with
research that that is trying to find a
better treatment for HIV.
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You may get a new drug that turns out
to be an effective treatment.
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You will contribute to the understanding
of HIV and it’s consequences.
Reasons to Join a Trial
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You will be carefully monitored during
the trial.
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You will receive support and education
about your HIV and your medications.
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Usually, the lab tests, medications and
visits to the doctor are free to you.
Reasons Not to Join a Trial
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You may have to stop taking other
medications that may be helping you.
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The new drug may actually make you
worse, or not help you at all.
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The new drug may have side effects
and be unsafe.
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Joining a trial may take extra time that
you don’t feel you can spare.
Someone to Watch over You
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Institutional Review Board (IRB), also
called Ethics Review Board.
Occasionally a Data Safety and
Monitoring Board (DSMB).
Food and Drug Administration (FDA).
If you are kept out of a trial because of
your race, ethnicity, national origin, sex,
age or sexual orientation, you can file a
complaint with a local human rights
agency.
Who Else?
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At many study sites, including Swedish,
the doctors and nurses work for the
hospital, not the drug company
sponsoring the trial.
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Activist organizations like ACT UP
monitor drug company trials and cry foul
if a trial appears to be unethical.
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Community Advisory Boards (CAB).
Informed Consent
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Before you agree to join a trial, you will
be asked to sign a consent form.
The consent form should be in easy-tounderstand language, and explain the
purpose and procedures of the trial,
including the side effects, possible risks
and benefits, and what procedures will
be done at each visit.
Informed Consent
Before You Sign
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You should have all your questions
answered, and know who to contact if
you should have more questions.
If English is not your primary language,
the study must provide a consent form
in your primary language. Additionally,a
trained medical interpreter should be
present.
Tips for the Informed
Consent Process
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Think about bringing a friend or family
member.
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Request a copy of the consent form
before your visit.
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Write down your questions in advance.
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Talk to your primary care provider about
the study if he/she isn’t the investigator.
Informed Consent
After You Sign
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You may withdraw from the study at any
time, simply by calling the study nurse.
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Withdrawing from a study will not affect
any regular medical care you may be
receiving from the health care providers
conducting the study.
Women and Children in HIV Trials
Yes!
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Most data on the safety and
effectiveness of drugs has been
obtained from research with men.
Women react differently to medications
than men. So do children.
HIV affects women and children
differently than men.
Pregnancy and HIV.
Questions to Ask
About the Study
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What is the name of the trial?
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What Phase is the trial (I, II, III or IV)?
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Is it double-blind or open-label?
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How long does this trial last?
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Do I need to be in the hospital for this
trial?
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How often must I visit the site?
Questions to Ask
About the Study
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What will happen on these visits?
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How long will each visit take?
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Is child care available? Travel
reimbursement?
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Are the lab test and exams free?
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What will happen if I miss a visit or
forget to take the drugs?
Questions to Ask
About the Study
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Are there things I have to do at home?
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Are there drugs I cannot take?
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Are there things I cannot do while in this
study?
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Is this drug available outside the trial?
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If so, how can I get it?
Questions to Ask
About the Study
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How will the drug and study
requirements affect my day-to-day life?
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What tests will be done? How often?
Will I see the results of these tests?
Questions to Ask About the Drug
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What type of drug is it?
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Has this drug been used before?
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How many people have used this drug?
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What is the evidence that it works?
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What other drugs are used for this
condition?
Questions to Ask About the Drug
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What are the possible side effects?
• Short Term
• Long Term
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Will I receive help with these side
effects?
Questions to Ask About the Drug
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Is the drug free or do I need to pay
for it?
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Will the drug be available to me after
I complete the study?
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What happens when the drug is
available by prescription?
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Will treatment be available to me
even if I leave the trial?
Questions to Ask About the
Money and Payment
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Do I need health insurance?
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Do I have to pay for lab tests or other
things?
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Who pays for medical care if I get sick
from the drug?
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Will I be given any money for
participating in the trial?
How to Find a Trial
in the United States
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AIDS Clinical Trials Group
AIDS Clinical Trials Information Service
(ACTIS) 1.800.TRIALSA
Online: http://www.clinicaltrials.gov/
How to Find a Trial
Outside the US
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Many of the trials listed on
http://www.clinicaltrials.gov/
and in ACTIS are multinational
Corporate sponsors usually have their
trials listed on their web page.
The medicine regulatory board of your
country.