HIV Clinical Trials Janice Price, M.Ed, RN HIV Clinical Research Program Coordinator Swedish Medical Center Seattle, WA USA

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HIV Clinical TrialsJanice Price, M.Ed, RNHIV
Clinical Research Program CoordinatorSwedish
Medical CenterSeattle, WA USA
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HIV Positive? Take Control

• 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

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What is a Clinical Drug Trial?

• 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.

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HIV Clinical Drug TrialsWho are they for?

• 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.

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Types of Drug Trials

• Phase I Is the drug safe?
• Phase II What dose is best and does it look
  like it will work?
• Phase III How safe and effective is the drug in
  a large number of people?
• Phase IV Studies after a drug is approved.

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Controlled Trials

• 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.

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Open Label Trials

• 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.

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Double-Blind Trials

• The most scientific way to run a study.
• No one knows exactly what drugs the participants
  are getting, neither the study personnel nor the
  doctors.
• Can be placebo-controlled. Make sure to ask
  detailed questions about treatment groups.

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What is a Placebo?

• A placebo is a dummy drug made to look exactly
  like the real drug.
• Placebos are used along with the real drug to
  keep study participants (and the doctors and
  nurses) from knowing what drug they are taking.
• This removes bias.

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Placebo-Controlled Trial

• 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.
• Example Active Drug A Placebo of Drug B vs.
  Placebo of Drug A Active Drug B.

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Reasons to Join a Trial

• There may be no drug approved for your condition,
  and you might be given a drug you cant get
  elsewhere.
• You might not be able to take one of the approved
  drugs because of the side effects.
• You continue to get sick, even though youre
  taking an approved drug.

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Reasons to Join a Trial

• You are interested in helping with research that
  that is trying to find a better treatment for
  HIV.
• You may get a new drug that turns out to be an
  effective treatment.
• You will contribute to the understanding of HIV
  and its consequences.

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Reasons to Join a Trial

• You will be carefully monitored during the trial.
• You will receive support and education about your
  HIV and your medications.
• Usually, the lab tests, medications and visits to
  the doctor are free to you.

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Reasons Not to Join a Trial

• You may have to stop taking other medications
  that may be helping you.
• The new drug may actually make you worse, or not
  help you at all.
• The new drug may have side effects and be unsafe.
• Joining a trial may take extra time that you
  dont feel you can spare.

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Someone to Watch over You

• 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.

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Who Else?

• At many study sites, including Swedish, the
  doctors and nurses work for the hospital, not the
  drug company sponsoring the trial.
• Activist organizations like ACT UP monitor drug
  company trials and cry foul if a trial appears to
  be unethical.
• Community Advisory Boards (CAB).

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Informed Consent

• Before you agree to join a trial, you will be
  asked to sign a consent form.
• The consent form should be in easy-to-understand
  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.

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Informed ConsentBefore You Sign

• 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.

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Tips for the Informed Consent Process

• Think about bringing a friend or family member.
• Request a copy of the consent form before your
  visit.
• Write down your questions in advance.
• Talk to your primary care provider about the
  study if he/she isnt the investigator.

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Informed ConsentAfter You Sign

• You may withdraw from the study at any time,
  simply by calling the study nurse.
• Withdrawing from a study will not affect any
  regular medical care you may be receiving from
  the health care providers conducting the study.

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Women and Children in HIV TrialsYes!

• 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.

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Questions to Ask About the Study

• What is the name of the trial?
• What Phase is the trial (I, II, III or IV)?
• Is it double-blind or open-label?
• How long does this trial last?
• Do I need to be in the hospital for this trial?
• How often must I visit the site?

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Questions to Ask About the Study

• What will happen on these visits?
• How long will each visit take?
• Is child care available? Travel reimbursement?
• Are the lab test and exams free?
• What will happen if I miss a visit or forget to
  take the drugs?

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Questions to Ask About the Study

• Are there things I have to do at home?
• Are there drugs I cannot take?
• Are there things I cannot do while in this study?
• Is this drug available outside the trial?
• If so, how can I get it?

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Questions to Ask About the Study

• How will the drug and study requirements affect
  my day-to-day life?
• What tests will be done? How often? Will I see
  the results of these tests?

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Questions to Ask About the Drug

• What type of drug is it?
• Has this drug been used before?
• How many people have used this drug?
• What is the evidence that it works?
• What other drugs are used for this condition?

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Questions to Ask About the Drug

• What are the possible side effects?
• Short Term
• Long Term
• Will I receive help with these side effects?

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Questions to Ask About the Drug

• Is the drug free or do I need to pay for it?
• Will the drug be available to me after I complete
  the study?
• What happens when the drug is available by
  prescription?
• Will treatment be available to me even if I leave
  the trial?

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Questions to Ask About the Money and Payment

• Do I need health insurance?
• Do I have to pay for lab tests or other things?
• Who pays for medical care if I get sick from the
  drug?
• Will I be given any money for participating in
  the trial?

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How to Find a Trialin the United States

• AIDS Clinical Trials Group
• AIDS Clinical Trials Information Service (ACTIS)
  1.800.TRIALSA
• Online http//www.clinicaltrials.gov/

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How to Find a Trial Outside the US

• Many of the trials listed on http//www.clinicaltr
  ials.gov/
• and in ACTIS are multinational
• Corporate sponsors usually have their trials
  listed on their web page.
• The medicine regulatory board of your country.