Are you suffering from HIV related pain such as tingling, “Pins and Needles” or burning sensations in both feet?
If so, you may be eligible to participate in a research study of an investigational patch for the treatment of HIV-associated neuropathy. The patch is applied only once for 30 or 60 minutes, then removed.
To be eligible for this study, you must:
- Be a male or female over 18 years of age or older
- Have a documented diagnosis of HIV infection
- Have experienced mild to severe pain, burning or discomfort in both feet for at least 2 months.
WHAT IS THE PURPOSE OF THE STUDY?
NGX-4010 is an experimental capsaicin patch for the potential treatment of painful HIV-associated neuropathy.
The purpose of this study is to determine if an experimental drug is safe and effective as a potential treatment for the pain from HIV-associated neuropathy (HIV-AN.) NGX-4010 has not received approval by the U.S. Food and Drug Administration (FDA) or the Therapeutic Goods Administration of Australia (TGA).
WHO WILL BE INVOLVED?
There will be 480 people in this study. Study participants will be randomized to receive either the high-concentration or the low-concentration patch. Randomized means the patient will be assigned to receive one of the patches by chance, like flipping a coin. Overall, about 320 subjects will receive the high-concentration patch and 160 will receive the control patch (low-concentration capsaicin). The patient and the study doctor and coordinator will not know which kind of patch he/she receives until the study is over. This is done so that the safety and effects of the experimental drug can be studied in a fair manner. In a medical emergency, the patient’s doctor can find out which patch he/she had if this information is needed to treat him/her.
WHAT WILL HAPPEN TO PARTICIPANTS?
The capsaicin patch will be applied to the skin directly over the painful areas. The length of time that the study patches are left on the patients painful areas during the initial treatment will be 30 or 60 minutes. Overall, about 240 of the subjects will receive initial treatment for 30 minutes and 240 subjects for 60 minutes. The patient and study doctor will know how long the patches are left on.
Sometimes we don’t know which way of treating patients is best. To find out, we need to make comparisons between the different treatments. We put people into groups and give each group a different treatment; the results are compared to see if one is better. To try to make sure the groups are the same to start with, each patient is put into a group by chance (randomly). The results are then compared.
This is a “double blind trial.” This means that neither the patient nor their doctor will know which treatment group the patient is in (although, if the doctor needs to find out he/she can do so, if medically necessary).
Participation in this study will last about 14 weeks. There will be a total of five scheduled visits to the study doctor’s office during the study. A patient will come in at 4, 8, and 12 weeks after the initial treatment in the study. Participants will also be contacted over the phone throughout the study to see how they are doing.
Information on the study provided herein is extracted from the consent form approved by the relevant Ethics Board– potential participants in the study should obtain the approved consent form for their review.
PLEASE SEE ALSO CLINICAL TRIALS OVERVIEW
For more information, or a copy of the Consent Form, please email us at trials@holdsworthhouse.com.au
Or call the trials team on (02) 9331 7228
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