TO GET HELP, PLEASE REFER TO THE EXPANDED ACCESS PAGE. IF YOUR HEALTH IS DETERIORATING AND YOU HAVE RESISTANCE TO
ALL AVAILABLE HIV MEDICATIONS, YOU MAY WANT TO APPLY FOR A SINGLE PATIENT IND. THIS IS A BRIEF DESCRIPTION OF THE PROCEDURE.

How to apply for Emergency Treatment IND (Single Patient) access of an investigational drug:

If your HIV has evidence of resistance to all commercially available antiretrovirals and your viral load suggests that your HIV is not responding to your current drug regimen, have a genotypic drug resistance test
performed.

Once the results from the test are available, there are a number of possible options:

1- Consider repeating drug-resistance testing, using a phenotypic assay. This may include the testing of virus sensitivity to Fuzeon, although this test may be separate and
    may not be reimbursed in some settings ( history of Fuzeon use and resistance may suffice )

2- If you have at least one active drug to which you may show sensitivity in your genotype or phenotype test, talk to your doctor about the advantages and disadvantages of
    entering any phase II/III studies

3- If your health is at risk (your CD4 is under 50 cells/ml), and you have developed resistance to all commercially available or expanded access HIV medications, and you and
your doctor deem that you cannot risk being on virtual monotherapy by joining research studies, ask your doctor to:

     a-Call the company that carries the medication that may help you to find out if they are willing to help you by providing free drug

     b- After having the manufacturer agree to provide the investigational drug via Single Patient IND, the doctor should follow the procedure described here to fill the required
         forms and get IRB (institutional review board) approval. This procedure is hardly used by doctors in HIV care due to lack of information or concerns about its complexity. The
         link which describes the entire procedure is http://www.fda.gov/cder/cancer/singleIND.htm. Three simple forms, a signed patient consent form and IRB (Institutional Review
         Board) approval are needed. Many locals IRBs expedite approval of this kind of request due to its urgency. Also, single patient IND can be approved verbally by the FDA if the
         patient has an expected survival of less than 30 days (this is called emergency IND) so that the drug company can ship the drug in an expedited manner, but the forms will
         still need to be processed while drug shipment is being processed. These are the forms to be filled for the application:

http://www.fda.gov/cder/regulatory/applications/EIND_request.doc

http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1571.doc

http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1572.doc

For a sample consent form and cover letter for IRB submission go to:
     Click here for Consent form  (DOC)
     Click here for Cover Letter  (DOC)

FOR MORE INFORMATION, PLEASE EMAIL NELSONVERGEL@YAHOO.COM