Clinical trial NCT00064623 (phase 3, status: completed)
Conditions: hiv infections, peripheral nervous system diseases, pain
ICD codes: Z21, G64, M35.06, P14.9, P14.8, C47.9, D36.10, R94.138, N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52
Drugs: capsaicin dermal patch
SMILES: COC1=C(O)C=CC(CNC(=O)CCCC\C=C\C(C)C)=C1
Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Documented evidence of HIV-1 infection

          -  Documented diagnosis of painful HIV-associated distal symmetrical polyneuropathy
             established by a neurologist resulting from HIV disease and/or antiretroviral drug
             exposure, with primary 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, and at least one of the following: distal diminution of vibration sensation
             or pain or temperature sensation in the legs

          -  Either no neurotoxic antiretroviral (didanosine, zalcitabine or stavudine) exposure
             for at least 8 weeks prior to Screening Visit, or currently on stable dose(s) of any
             neurotoxic antiretroviral(s) for at least 8 weeks prior to Screening Visit

          -  Screening Pain Sum Score of 12 to 36

          -  Karnofsky Performance Score of greater than or equal to 60

          -  Intact, unbroken skin over the painful area(s) to be treated

          -  If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21
             days prior to Treatment Visit and willing to maintain these medications at the same
             stable dose(s) and schedule throughout the 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 participating in
             a conception process during study and for 30 days following experimental drug exposure

          -  Willing and able to comply with protocol requirements for duration of study

        Exclusion Criteria:

          -  Concomitant opioid medication, unless orally or transdermally administered and not
             exceeding a total daily dose of morphine 60 mg/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 treatment, or high tolerance to opioids
             precluding the ability to relieve treatment-associated discomfort with Roxicodone® or
             Vicodin®, as judged by the Investigator

          -  Active substance abuse or history of chronic substance abuse within the past year, or
             prior chronic substance abuse judged likely to recur during the study period by the
             investigator

          -  Recent use (within 21 days preceding the Treatment Visit 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

          -  Current use of any investigational agent or Class 1 anti-arrhythmic drugs

          -  Significant pain of an etiology other than painful HIV-associated neuropathy;
             significant ongoing pain from other cause(s) that may interfere with judging
             HIV-associated neuropathy pain

          -  Evidence of another contributing cause for peripheral neuropathy, e.g., diabetes
             mellitus requiring medication control (i.e., oral hypoglycemics, insulin); hereditary
             neuropathy; vitamin B12 deficiency (B12 level ≤ 200 pg/mL) or less than 3 months of
             B12 supplementation prior to Screening Visit; or treatment within 90 days prior to
             Screening Visit with any drug that may have contributed to the sensory neuropathy

          -  Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral
             nerve stimulator) for the treatment of neuropathic pain

          -  Treatment for acute opportunistic infections within 14 days before Treatment Visit

          -  Presence of acute, active opportunistic infection, except oral thrush; oral, genital,
             or rectal herpes; and Mycobacterium avium bacteremia within 2 weeks prior to Screening
             Visit

          -  Currently have active malignant disease

          -  Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or
             pulmonary function that may interfere either with the ability to complete the study or
             the evaluation of adverse events

          -  Hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local
             anesthetics, Roxicodone®, Vicodin®, or adhesives