Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy
Completed · Phase 3
Conditions studied: HIV Infections, Peripheral Nervous System Diseases, Pain
In brief
The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is effective in treating painful HIV-associated neuropathy.
Key facts
- Study ID
- NCT00064623
- Run by
- NeurogesX
- People needed
- 300
- Starts
- 2003-08-01
- Expected to finish
- 2005-11-01
- Last updated by the study team
- 2008-03-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- NeurogesX Investigational Site — Phoenix, Arizona, United States
- NeurogesX Investigational Site — Phoenix, Arizona, United States
- NeurogesX Investigational Site — Berkeley, California, United States
- NeurogesX Investigational Site — San Diego, California, United States
- NeurogesX Investigational Site — San Francisco, California, United States
- NeurogesX Investigational Site — Stanford, California, United States
- NeurogesX Investigational Site — West Hollywood, California, United States
- NeurogesX Investigational Site — Fort Lauderdale, Florida, United States
- NeurogesX Investigational Site — Miami, Florida, United States
- NeurogesX Investigational Site — Miami, Florida, United States
- NeurogesX Investigational Site — North Palm Beach, Florida, United States
- NeurogesX Investigational Site — Orlando, Florida, United States
- NeurogesX Investigational Site — Sunrise, Florida, United States
- NeurogesX Investigational Site — Vero Beach, Florida, United States
- NeurogesX Investigational Site — Honolulu, Hawaii, United States
- NeurogesX Investigational Site — Chicago, Illinois, United States
- NeurogesX Investigational Site — Lexington, Kentucky, United States
- NeurogesX Investigational Site — Baltimore, Maryland, United States
- NeurogesX Investigational Site — Boston, Massachusetts, United States
- NeurogesX Investigational Site — Springfield, Massachusetts, United States
- NeurogesX Investigational Site — Detroit, Michigan, United States
- NeurogesX Investigational Site — Minneapolis, Minnesota, United States
- NeurogesX Investigational Site — St Louis, Missouri, United States
- NeurogesX Investigational Site — Camden, New Jersey, United States
- NeurogesX Investigational Site — Albany, New York, United States
Full record on ClinicalTrials.gov
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