For those interested...

[J.R.E.]

U.S. Food & Drug Administration (FDA) Weekly Digest Bulletin:

HIV/AIDS Update - Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research: June 14, 2013
05/13/2013
FDA is announcing a Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research
Date:
June 14, 2013

Time:
9:30 a.m. to 5:30 p.m

Location:
FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Room 1503A (Great Room)
Silver Spring, MD 20993

On June 14, 2013, as part of the Patient-Focused Drug Development initiative intended to enhance patient input, FDA will be hosting a public meeting on human immunodeficiency virus (HIV) Patient-Focused Drug Development and HIV Cure Research. FDA is interested in obtaining patient input on the impact of HIV on daily life and currently available therapies to treat the condition (topic 1), and patients’ views on issues related to HIV cure research (topic 2).

Topic 1 is expected to be discussed from approximately 9:30 AM to noon, and Topic 2 approximately 1:30 - 5:30 PM.

Questions intended to frame discussion on these topics are provided below.

For each topic, a panel of patients and patient representatives/advocates will present comments to begin the dialogue which will be followed by a facilitated discussion inviting comments from other patients and patient representatives in the White Oak audience.

If you are interested in providing comments as part of one of the initial panel discussions, please indicate so during the registration process. Participants selected for the panel discussions will be confirmed prior to the meeting.

There will also be an opportunity for patients, patient representatives and others to provide comments on issues other than topics 1 and 2 during an Open Public Comment session. Sign up for Open Public Comment will take place the day of the meeting. For more information, refer to the FDA Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research website (http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm348598.htm).

There is no cost for registration, but please register (below) by June 5, 2013.

The meeting will be webcast, however, remote viewers will not be able to directly participate in the discussions.

Questions for Discussion

Topic 1: Patients’ perspective on current approaches to managing HIV and on symptoms experienced because of HIV or its treatment

1) What are you currently doing to help manage your HIV and any symptoms you experience because of your condition or other therapies? (Examples may include prescription medicines, over-the-counter products, and non-drug therapies such as diet modification.)

a) What specific symptoms do your therapies or treatments address?

b) How long have you been on treatment and how has your treatment regimen changed over time?

2) How well does your current treatment regimen treat any significant symptoms of your condition?

a) How well have these treatments worked for you as your condition has changed over time?

b) Are there symptoms that your current regimen does not address at all, or does not treat as well as you would like?

3) What are the most significant downsides to your current therapies or treatments, and how do they affect your daily life? (Examples of downsides could include bothersome side effects, physical change to your body because of treatment, going to the hospital for treatment, etc.)

4) Of all the symptoms that you experience because of your condition, or because of your therapy or treatment, which 1-3 symptoms have the most significant impact on your life? (Examples could include diarrhea, insomnia, difficulty concentrating, etc.)

a) Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include sleeping through the night, daily hygiene, driving, etc.)

5) Assuming there is currently no complete cure for your condition, what specific things would you look for in an ideal therapy or treatment to manage your condition?

Topic 2: Patients’ perspectives on HIV Cure Research

1) What do you believe are the benefits of participating in an HIV cure research study?

2) What would motivate you to participate or to not participate in an HIV cure research study?

3) What risks would you find unacceptable for participating in an HIV cure research study, and why? (Examples of risks that may be associated with participation in an HIV cure research study include common side effects such as nausea and fatigue, and less common but serious adverse events such as blood clots, infection, seizures and cancer.)

4) In certain HIV cure research studies, you would be asked to stop any other HIV medications that you are currently taking. How would this affect your decision whether to participate in an HIV cure research study?

5) The process of informed consent is an important way for the researchers to communicate the purpose of an HIV research study, as well as its expected benefits and potential risks, so that people can make an informed decision whether to participate in the study.

a) How should the informed consent clearly communicate to you the purpose of an HIV cure research study, particularly when a study is designed only to provide scientific information that could guide future research and development of treatments?

b) How should the informed consent clearly communicate to you the potential benefits of an HIV cure research study? In particular, how should the informed consent describe benefit when we do not think that participants in the study may gain any direct health benefits?

c) How should informed consent communicate clearly to you the potential risks of participating in an HIV cure research study? In particular, how should the informed consent describe a study if there is very limited understanding about how the medications or interventions may affect participants or what are the potential risks of those interventions or medications?

d) Is there any other information that you would find helpful when deciding whether to enter an HIV cure research study?

6) What else do you want FDA to know about HIV Cure Research from your perspective?

Registration:

To register for this meeting, visit http://patientfocusedhiv.eventbrite.com.
→ Registration will close on June 5, 2013.

The registration website contains links to background materials, and will be updated as additional meeting materials are developed, including a background document intended to help, along with the questions above, to frame discussion on the day of the meeting.  That backgrounder will also be provided via this list serve prior to the meeting.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration



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05/15/2013
 

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