Patients with no HIV Treatment options in the US Survey

This short survey will provide very important information to a team of physicians, treatment advocates, the FDA, and researchers who are reviewing the current needs for expanded access programs of HIV investigational medications.

1. New HIV medications have allowed most patients to suppress their HIV. However viral load in some patients--despite good adherence--cannot be suppressed with commercially-available medicines.
Please help us estimate the number of patients in the United States that have one or no commercially available ARV treatment options by taking a few minutes to answer this survey. Please forward it to other physicians if you can.

Please indicate the number of HIV patients for whom you are the primary care provider of record.

New HIV medications have allowed most patients to suppress their HIV. However viral load in some patients--despite good adherence--cannot be suppressed with commercially-available medicines. Please help us estimate the number of patients in the United States that have one or no commercially available ARV treatment options by taking a few minutes to answer this survey. Please forward it to other physicians if you can. Please indicate the number of HIV patients for whom you are the primary care provider of record. less than 10

10-50

51-100

101-250

251-500

501 or more

2. How many patients in your practice have only one or zero fully active commercially available HIV antiretroviral agents, such that you are currently unable to construct a fully suppressive regimen for them? (Include patients with detectable viral load for whom drugs are not fully active due to resistance, poor absorption, or intolerance. This will probably include any patients with integrase-resistance. The presence of a CXCR4-using virus should be considered as "resistance" to maraviroc.)

How many patients in your practice have only one or zero fully active commercially available HIV antiretroviral agents, such that you are currently unable to construct a fully suppressive regimen for them? (Include patients with detectable viral load for whom drugs are not fully active due to resistance, poor absorption, or intolerance. This will probably include any patients with integrase-resistance. The presence of a CXCR4-using virus should be considered as "resistance" to maraviroc.) None

One

Two

Three

Four

More than 4? (please specify)

3. Where do you currently practice? (check all that apply)

Where do you currently practice? (check all that apply) Private Practice

Academic Institution/hospital

Public (Ryan White funded) clinic

Veterans Administration hospital

Government funded clinic/hospital

4. Are you part of any research network and/or do you conduct HIV clinical trials in your practice/institution?

Are you part of any research network and/or do you conduct HIV clinical trials in your practice/institution? Yes

No

5. Have you ever tried to apply for pre-approval access of investigational agents outside clinical studies or regular expanded access programs for individual MDR patients via the current FDA emergency treatment IND process?

Have you ever tried to apply for pre-approval access of investigational agents outside clinical studies or regular expanded access programs for individual MDR patients via the current FDA emergency treatment IND process? Yes

No (skip to question 7)

6. If you have applied for investigational drug access for your patients in the past, have you found the current FDA process easy or difficult to perform?

If you have applied for investigational drug access for your patients in the past, have you found the current FDA process easy or difficult to perform? Easy

Difficult

Reasonably complex

7. If you have not applied for early access of investigational agents for your MDR patients with limited to no options in the past, what were the main barriers to do so? (check all that apply)

If you have not applied for early access of investigational agents for your MDR patients with limited to no options in the past, what were the main barriers to do so? (check all that apply) I was not aware I could do this without being part of a clinical study

I found the process too complex

I do not have the administrative support to handle the required paper work

My institution does not support this kind of access outside clinical study settings

My institutional review board would not approve this kind of non-study access

I think the risks would outweigh the benefits for my MDR patients

I have used access via expanded access programs or clinical studies

I do not have relations with pharmaceutical companies to enable me to ask for drug access before approval

My MDR patients have been clinically stable and could wait for drug approval of two more agents

Other (please specify)

8. If you were to be provided administrative support, would you be interested in participating in an expanded access program (EAP) of three investigational HIV medications for your patients with limited treatment options?

If you were to be provided administrative support, would you be interested in participating in an expanded access program (EAP) of three investigational HIV medications for your patients with limited treatment options? Yes

Yes, but I would need local IRB approval

It depends on my academic institution’s policies

No

Depends on the EAP design

I am interested in hearing more and will provide contact information at the end of the survey

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9. If you are interested in knowing more about any updates on investigational treatment access for patients with no treatment options, please provide contact information. (Several fields are optional)

If you are interested in knowing more about any updates on investigational treatment access for patients with no treatment options, please provide contact information. (Several fields are optional) Name:
Address:
Address 2:
City/Town:
State:
ZIP/Postal Code:
Email Address:
Phone Number:

Thank you for your time and participation in this important survey. Results will be shared with participants who are interested in updates.

Patients with no HIV Treatment options in the US
Exit this survey

1. Default Section

3. Where do you currently practice? (check all that apply)

4. Are you part of any research network and/or do you conduct HIV clinical trials in your practice/institution?

5. Have you ever tried to apply for pre-approval access of investigational agents outside clinical studies or regular expanded access programs for individual MDR patients via the current FDA emergency treatment IND process?

6. If you have applied for investigational drug access for your patients in the past, have you found the current FDA process easy or difficult to perform?

7. If you have not applied for early access of investigational agents for your MDR patients with limited to no options in the past, what were the main barriers to do so? (check all that apply)

8. If you were to be provided administrative support, would you be interested in participating in an expanded access program (EAP) of three investigational HIV medications for your patients with limited treatment options?

*
9. If you are interested in knowing more about any updates on investigational treatment access for patients with no treatment options, please provide contact information. (Several fields are optional)

Patients with no HIV Treatment options in the USExit this survey

1. Default Section

3. Where do you currently practice? (check all that apply)

4. Are you part of any research network and/or do you conduct HIV clinical trials in your practice/institution?

5. Have you ever tried to apply for pre-approval access of investigational agents outside clinical studies or regular expanded access programs for individual MDR patients via the current FDA emergency treatment IND process?

6. If you have applied for investigational drug access for your patients in the past, have you found the current FDA process easy or difficult to perform?

7. If you have not applied for early access of investigational agents for your MDR patients with limited to no options in the past, what were the main barriers to do so? (check all that apply)

8. If you were to be provided administrative support, would you be interested in participating in an expanded access program (EAP) of three investigational HIV medications for your patients with limited treatment options?

*9. If you are interested in knowing more about any updates on investigational treatment access for patients with no treatment options, please provide contact information. (Several fields are optional)

Patients with no HIV Treatment options in the US
Exit this survey

*
9. If you are interested in knowing more about any updates on investigational treatment access for patients with no treatment options, please provide contact information. (Several fields are optional)