The purpose of the study was to assess the efficacy and safety of NGX-4010 applied for 30 or
60 minutes for the treatment of painful HIV-associated neuropathy.
Visit (usually on Day - 14). Subjects continued to record NPRS scores in a take-home diary
from the evening on the day of treatment through the evening before the Termination Visit at
Week 12. Subjects returned for interim follow-up visits at Weeks 4 and 8 following study
treatment.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Documented evidence of HIV-1 infection
- Documented diagnosis of painful HIV-associated distal symmetric polyneuropathy
resulting from HIV disease and/or antiretroviral drug exposure To be confirmed based
on symptoms of pain, burning or dysesthetic discomfort in both feet for at least 2
months prior to Screening Visit, AND absent or diminished ankle reflexes OR at least
one of following: distal diminution of vibration sensation or pain or temperature
sensation in legs
- Average NPRS scores during screening period of 3 to 9, inclusive
- Life expectancy of 12 months or longer per Investigator's judgment
- Intact, unbroken skin over painful areas to be treated
- If taking chronic pain medications, be on stable regimen for at least 21 days prior
to Day 0 and willing to maintain medications at same stable dose(s) and schedule
throughout study
- Female subjects with child-bearing potential: negative serum pregnancy test performed
at Screening Visit
- Willing to use effective methods of birth control and/or refrain from conception
process during study and for 30 days following study drug exposure
- Willing and able to comply with protocol for duration of study
Exclusion Criteria:
- Concomitant opioid medication, unless orally or transdermally administered and not
exceeding total daily dose of morphine 80 mg/day or equivalent; parenteral opioids
not allowed
- Unavailability of effective rescue medication strategy for subject, such as
unwillingness to use opioid analgesics during study treatment or high tolerance to
opioids precluding ability to relieve treatment-associated discomfort as judged by
investigator
- Active substance abuse or history of chronic substance abuse within past year or
prior chronic substance abuse (including alcoholism) judged likely to recur during
study period by investigator
- Recent use (within 21 days preceding Day 0) of any topically applied pain medication,
such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local
anesthetics including Lidoderm® (lidocaine patch 5%), steroids or capsaicin products
on painful areas
- Started or stopped treatment with one or more neurotoxic antiretroviral agents (ie,
didanosine [ddI], zalcitabine [ddC], or stavudine [d4T] during 8 weeks prior to Day 0
- Participation in previous clinical trial in which subject received either blinded or
open-label NGX-4010
- Current use of any investigational agent or Class 1 anti-arrhythmic drugs (such as
tocainide and mexiletine)
- Evidence of another contributing cause for peripheral neuropathy, e. g., current
uncontrolled diabetes mellitus (HbA1c≥9%) or history of diabetes mellitus preceding
onset of HIV-associated neuropathy (HIV-AN); hereditary neuropathy; vitamin B12
deficiency (B12 level ≤200pg/mL at screening); or treatment within 90 days prior to
Screening Visit with any drug that may have contributed to sensory neuropathy
- Hypertension, unless adequately controlled by medication
- Significant ongoing pain from other cause(s) that may interfere with judging HIV-AN
related pain
- Any implanted medical device for treatment of neuropathic pain
- Hypersensitivity to capsaicin (i. e., chili peppers or over-the-counter (OTC)
capsaicin products), local anesthetics, opioid-based oral analgesics or adhesives
- Significant medical conditions (including active malignancy defined as treatment
required in last 5 years) that in opinion of investigator would interfere with
ability to complete study or evaluation of AEs
- Recent significant medical-surgical intervention that in judgment of Investigator
would interfere with ability to complete study or evaluation of AEs; examples include
to major surgery, or receipt of immunosuppressive therapy within 3 months prior to
Day 0
- Evidence of cognitive impairment including dementia that may interfere with subject's
ability to complete daily pain diaries requiring recall of average HIV-associated
neuropathy pain level in past 24 hours