A MULTICENTER RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF NGX-4010 FOR THE TREATMENT OF PAINFUL HIV-ASSOCIATED NEUROPATHY

INTERVENTION: Product Name: TRANSACIN capsaicin Product Code: NGX‐4010 Pharmaceutical Form: Transdermal patch INN or Proposed INN: capsaicin CAS Number: 404‐86‐4 Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 6400‐ Product Name: capsaicin control patch Product Code: control patch Pharmaceutical Form: Transdermal patch INN or Proposed INN: capsaicin CAS Number: 404‐86‐4 Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 32‐ Product Name: LMX4 Pharmaceutical Form: Cream INN or Proposed INN: LIDOCAINE CAS Number: 137586 Concentration unit: % percent Concentration type: equal Concentration number: 4‐ CONDITION: Treatment of painful HIV‐associated neuropathy ; MedDRA version: 8.1 Level: PT Classification code 10054095 Term: Neuropathic pain PRIMARY OUTCOME: Main Objective: To assess the efficacy over 12 weeks of NGX‐4010 applied for 30 or 60 minutes for the treatment of painful HIV‐associated neuropathy ; Primary end point(s): The primary efficacy endpoint is the percent change from baseline in the “average pain for the past 24 hours” NPRS score during Weeks 2–12. ; NPRS means Numeric Pain Rating Scale Secondary Objective: To assess the safety of NGX‐4010 applied for 30 or 60 minutes for the treatment of painful HIV‐associated neuropathy INCLUSION CRITERIA: 1. At least 18 years of age. 2. Documented evidence of HIV‐1 infection. 3. Documented baseline diagnosis of painful HIV‐associated distal symmetric polyneuropathy resulting from HIV disease and/or antiretroviral drug exposure (see protocol) 4. Average NPRS scores for HIV‐AN associated pain during screening period of 3 to 9, inclusive. NPRS means Numeric Pain Rating Scale 5. Life expectancy of 12 months or longer per Investigator’s judgment 6. Intact, unbroken skin over the painful areas to be treated. 7. 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. 8. Female subjects with child‐bearing potential must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test, to be performed within 7 days of the Study Patch Application Visit. All su