clinical Trials - HIV / AIDS

HIV-Associated Neuropathy:

This clinical trial is designed to study the use of NGX-4010 for the treatment of painful HIV-associated neuropathy. This treatment is a topical patch embedded with the study medication. After reading the criteria if you are interested in this trial and/or you have additional questions, please call us at (702) 384-9101.

The following criteria are necessary for inclusion into this trial:

At least 18 years of age.
Documented evidence of HIV-1 infection.
Documented baseline diagnosis of painful HIV-associated distal symmetric polyneuropathy resulting from Human Immunodeficiency Virus (HIV) disease and/or antiretroviral drug exposure:

Specifically, the baseline diagnosis of HIV-AN will be confirmed based, in part, on the presence of primary symptoms of pain, burning or dysesthetic discomfort in both feet for at least 2 months prior to the Screening Visit, AND

Absent or diminished ankle reflexes, OR

At least one of the following:
Average NPRS scores for HIV-AN associated pain during screening period of 3 to 9, inclusive.
Life expectancy of 12 months or longer per Investigator’s judgment.
Intact, unbroken skin over the painful areas to be treated.
If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21 days prior to Study Patch Application Visit (Day 0) and willing to maintain medications at same stable dose(s) and schedule throughout the study.
Female subjects with child-bearing potential must have a negative serum hCG pregnancy test, to be performed within 7 days of the Study Patch Application Visit. All subjects must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study (or, in the event of early termination from the study, for 30 days following experimental drug exposure).
Be willing and able to comply with protocol requirements for the duration of study participation.
Subjects must sign an informed consent form for this study approved by the Investigator’s Institutional Review Board.

The following criteria would exclude a patient from this trial:

Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 80mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose.
Unavailability of an effective rescue medication strategy for the subject, such as unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort, as judged by the investigator.
Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse (including alcoholism) judged likely to recur during the study period by the investigator.
Recent use (within 21 days preceding the Study Patch Application Visit Day 0) of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics including Lidoderm, steroids or capsaicin products on the painful areas.
Have started or stopped treatment with one or more neurotoxic antiretroviral agents, or stavudine during the 8 weeks prior to Day 0.
Participation in a previous NeurogesX clinical trial in which subject received NGX-4010 (either blinded or open-label study treatment).
Current use of any investigational agent, or Class 1 anti-arrhythmic drugs.
Evidence of another contributing cause for peripheral neuropathy, e.g., current uncontrolled diabetes mellitus, vitamin B12 deficiency, or treatment within 90 days prior to Screening Visit with any drug that may have contributed to the sensory neuropathy.
Hypertension, unless adequately controlled by medication.
Significant pain of an etiology other than painful HIV-AN, for example, compression-related neuropathies, fibromyalgia or arthritis. Subjects must NOT have significant ongoing pain from other causes that may interfere with judging HIV-AN related pain.
Any implanted medical device for the treatment of neuropathic pain.
Hypersensitivity to capsaicin, local anesthetics, opioid-based oral analgesics, or adhesives.
Significant medical abnormalities or conditions, including active malignancy defined as treatment required in the last five years, that in the opinion of the investigator would interfere either with the ability to complete the study or the evaluation of AE’s.
Recent history of a significant medical-surgical intervention that in the judgment of the Investigator would interfere with the ability to complete the study or the evaluation of AE’s.
Evidence of cognitive impairment including dementia that may interfere with subject’s ability to complete daily pain diaries requiring subject’s recall of average HIV-AN pain level in the past 24 hours.