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

3. HIV Positive? Take Control n Find a provider you trust n Build a support system n Learn about your disease n Learn about your treatment options –No Treatment –Treatment by Prescription –Clinical Trials

4. What is a Clinical Drug Trial? n Drug trials are also called clinical trials or studies. n A trial is a controlled experiment in which people take a drug to find out if it works and if it is safe. n It is necessary to prove that a drug is safe and effective before it can be legally sold in most countries, including the US.

5. HIV Clinical Drug Trials Who are they for? n People who have never been treated for their HIV. n People who have been treated before but need to change their medications. n People with opportunistic infections. n People who need extra guidance with taking their medications. n People who want to contribute to the understanding of HIV treatment.

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

7. Controlled Trials n People are placed, at random, into one or more groups in the study. n One group will get the investigational drug (the one being studied), and one will get the already-approved current standard treatment. n Open label trials. n Double blind trials.

8. Open Label Trials n Each person knows exactly what drugs they are getting. n Randomization into groups often occurs. The investigator usually does not have control over this process. n The study personnel know what drugs everyone is getting. n There are no secrets here.

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

10. What is a Placebo? n A placebo is a “dummy drug” made to look exactly like the real drug. n Placebos are used along with the real drug to keep study participants (and the doctors and nurses) from knowing what drug they are taking. n This removes ‘bias’.

11. Placebo-Controlled Trial n 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. n Example: Active Drug A + Placebo of Drug B vs. Placebo of Drug A + Active Drug B.

12. Reasons to Join a Trial n There may be no drug approved for your condition, and you might be given a drug you can’t get elsewhere. n You might not be able to take one of the approved drugs because of the side effects. n You continue to get sick, even though you’re taking an approved drug.

13. Reasons to Join a Trial n You are interested in helping with research that that is trying to find a better treatment for HIV. n You may get a new drug that turns out to be an effective treatment. n You will contribute to the understanding of HIV and it’s consequences.

14. Reasons to Join a Trial n You will be carefully monitored during the trial. n You will receive support and education about your HIV and your medications. n Usually, the lab tests, medications and visits to the doctor are free to you.

15. Reasons Not to Join a Trial n You may have to stop taking other medications that may be helping you. n The new drug may actually make you worse, or not help you at all. n The new drug may have side effects and be unsafe. n Joining a trial may take extra time that you don’t feel you can spare.

16. Someone to Watch over You n Institutional Review Board (IRB), also called Ethics Review Board. n Occasionally a Data Safety and Monitoring Board (DSMB). n Food and Drug Administration (FDA). n 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.

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

18. Informed Consent n Before you agree to join a trial, you will be asked to sign a consent form. n 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.

19. Informed Consent Before You Sign n You should have all your questions answered, and know who to contact if you should have more questions. n 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.

20. Tips for the Informed Consent Process n Think about bringing a friend or family member. n Request a copy of the consent form before your visit. n Write down your questions in advance. n Talk to your primary care provider about the study if he/she isn’t the investigator.

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

22. Women and Children in HIV Trials Yes! n Most data on the safety and effectiveness of drugs has been obtained from research with men. n Women react differently to medications than men. So do children. n HIV affects women and children differently than men. n Pregnancy and HIV.

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

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

25. Questions to Ask About the Study n Are there things I have to do at home? n Are there drugs I cannot take? n Are there things I cannot do while in this study? n Is this drug available outside the trial? n If so, how can I get it?

26. Questions to Ask About the Study n How will the drug and study requirements affect my day-to-day life? n What tests will be done? How often? Will I see the results of these tests?

27. Questions to Ask About the Drug n What type of drug is it? n Has this drug been used before? n How many people have used this drug? n What is the evidence that it works? n What other drugs are used for this condition?

28. Questions to Ask About the Drug n What are the possible side effects? Short Term Long Term n Will I receive help with these side effects?

29. Questions to Ask About the Drug n Is the drug free or do I need to pay for it? n Will the drug be available to me after I complete the study? n What happens when the drug is available by prescription? n Will treatment be available to me even if I leave the trial?

30. Questions to Ask About the Money and Payment n Do I need health insurance? n Do I have to pay for lab tests or other things? n Who pays for medical care if I get sick from the drug? n Will I be given any money for participating in the trial?

31. How to Find a Trial in the United States n AIDS Clinical Trials Group n AIDS Clinical Trials Information Service (ACTIS) 1.800.TRIALSA n Online: http://www.clinicaltrials.gov/http://www.clinicaltrials.gov/

32. How to Find a Trial Outside the US n Many of the trials listed on http://www.clinicaltrials.gov/ http://www.clinicaltrials.gov/ n and in ACTIS are multinational n Corporate sponsors usually have their trials listed on their web page. n The medicine regulatory board of your country.