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human trials
Nov 20, 2000

hi docs!

I just have a question about human trials I keep reading about and hope you can answer. I read Medscape.com antiviral human trials list and want to know how long each drug is tested? example: drug is in phase (1) .. how long is phase 1 and how many phases are there before it is approved by FDA?

I have to say there were more drugs than i expected and have never heard about.

Although i am somewhat unhappy with my current cocktail with problems such as lipodistrophy, i would be willing to wait before switching to other drugs if i knew how long it would be before new drugs are approved. i beleive the least amount of drugs you have been on the less likely you will develop resistance to newer drugs.

also if you know of any other web addresses with more detailed info on new drugs comming out? thanks for your response. MC

Response from Dr. Pavia

Dear MC.

Here is the quick guide to the phases of drug testing.

Phase I is where you establish that a drug is reasonably safe, and try and determine an appropriate dose to use by studying how the drug is handled in the body. Some of this testing takes place in healthy volunteers, and some may be in PWHIV. Phase I studies expose patients to anywhere from a single dose to perhaps 12 weeks. The total of phase I may take a year or more.

Phase II is designed to establish preliminary evidence that the drug is active, reasonably well tolerated and effective. These studies are done in people with the disease. The studies are usually still looking to establish the best way to use the drug, and may test more than one dose. The trials are usually smaller in size but some phase II studies are continued for well over a year.

Phase III includes what are called pivotal trials. The purpose of phase III is to show that the drug is safe and effective and is a significant addition to the arsenal. Phase III studies include hundreds of patients and usually compare the drug to a standard regimen. In a well designed phase III study, you will get the standard of care if you are on the control arm, and hopefully the experimental drug will be as good or better.

There are good data on drugs in several places on this site, along with a service to look at trials. Other sites that may be helpful include HIVinsite, (www.hivinsite.ucsf.edu) which has a good trial finder, and the Johns Hopkins AIDS site (www/hopkins-aids.edu) There are many good links on this site and on the ones I mentioned. Happy surfing, and we really need the help of volunteers in order to find new meds and improve treatment. I am eternally greatful to the thousands who have participated in trials throughout the epidemic.

ATP

Andrew T. Pavia, M.D.



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