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 anti-retrovirals (ARVs)  and your viral load suggests that your HIV is not responding to your current drug regimen, have a genotypic resistance test performed. If your doctor has not done so yet, also have a tropism test done.

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.

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 investigational ARV that may help you to find out if they are willing to help you by providing free drug before it gets approved.  GSK carries GSK572 (new integrase inhibitor that may work for many patients with raltegravir resistance) and Taimed carries ibalizumab ( an entry inhibitor ARV in a new class). Both drugs have gone through dosing and safety studies. For GSK572, they need to know your integrase resistance mutations, so make sure that information is included in your genotype/phenotype tests.

     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 (it is a little time consuming but not too complex). The link which describes the entire procedure is 
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm163982.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. 

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)