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.

Condition	Treatment or Intervention	Phase
HIV Infections Peripheral Nervous System Diseases Pain	Drug: Capsaicin Dermal Patch	Phase II Phase III

Further Study Details: 

Expected Total Enrollment:  300

The C107 study is a randomized, double-blind, controlled dose finding study of NGX-4010 for the treatment of painful symptoms of HIV-associated neuropathy. Participants will be randomly assigned to receive initial treatment according to one of three doses (application durations), and to receive double-blind NGX-4010 patch (high-concentration capsaicin) or matching control (low-concentration capsaicin).

Participants who complete study evaluations through Week 12 will have the option of receiving up to 3 additional open-label treatments.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Key Eligibility Criteria:

• Must have had HIV-associated neuropathy for at least 2 months, with moderate to severe pain in both feet.
• Must not have significant pain in feet due to other causes (for example, arthritis).
• Must have intact skin at the treatment area.
• Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (one year).
• Must not use topical pain medications for HIV-associated neuropathy.
• Must be able to comply with study requirements such as completing daily pain diary and attending study visits and refrain from extensive travel during study participation.
• Must be at least 18 years old, not pregnant, and able to take care of self independently, with only occasional assistance if needed.
• No significant medical problems of the heart, kidneys, liver or lungs, or cancer.
• No history or current problem with substance abuse.

Arizona
      Arizona Clinical Research, Phoenix,  Arizona,  85023,  United States
      Body Positive, Phoenix,  Arizona,  85006,  United States
California
      AIDS Research Alliance, West Hollywood,  California,  90069,  United States
      East Bay AIDS Center, Berkeley,  California,  94705,  United States
      University of California, San Diego, San Diego,  California,  92103,  United States
      Stanford University Medical Center, Stanford,  California,  94305,  United States
      First Clinical Research, San Francisco,  California,  94117,  United States
Florida
      Orlando Immunology Center, Orlando,  Florida,  32804,  United States
      Steinhart Medical Center, Miami,  Florida,  33133,  United States
      Neurology Clinical Research, Plantation,  Florida,  33324,  United States
      University of Miami School of Medicine, Miami,  Florida,  33136,  United States
      Treasure Coast Infectious Disease Consultants, Vero Beach,  Florida,  32960,  United States
      Infectious Disease of the Palm Beaches Associates, North Palm Beach,  Florida,  33408,  United States
      Biogenomx Research Institute, Fort Lauderdale,  Florida,  33306,  United States
Hawaii
      HACRP - University of Hawaii, Honolulu,  Hawaii,  96816,  United States
Illinois
      Cook County Hospital, Dept. of Neurological Sciences, Chicago,  Illinois,  60612,  United States
Kentucky
      University of Kentucky, Lexington,  Kentucky,  40536,  United States
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21205,  United States
Massachusetts
      Community Research Initiative of New England, Boston,  Massachusetts,  02215,  United States
      Community Research Initiative of New England, Springfield,  Massachusetts,  01107,  United States
Michigan
      Wayne State University, Detroit,  Michigan,  48201,  United States
Minnesota
      Park Nicollet Health Clinic, Minneapolis,  Minnesota,  55416,  United States
Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  63108,  United States
New Jersey
      The Cooper Health System, Camden,  New Jersey,  08103-1489,  United States
New York
      Mount Sinai School of Medicine, Department of Neurology, New York,  New York,  10029,  United States
      Albany Medical Center, Albany,  New York,  12208,  United States
      New York Presbyterian Hospital, New York,  New York,  10021,  United States
North Carolina
      University of North Carolina at Chapel Hill, Chapel Hill,  North Carolina,  27599,  United States
Ohio
      Case Western Reserve, Cleveland,  Ohio,  44106,  United States
Oregon
      The Research and Education Group, Portland,  Oregon,  97209,  United States
Texas
      Integra Clinical Research, LLC, San Antonio,  Texas,  78229,  United States
      North Dallas Center for AIDS & Clinical Research, Dallas,  Texas,  75208,  United States
      Central Texas Clinical Research, Austin,  Texas,  78705,  United States
      University of Texas Health Science Center, Houston,  Texas,  77030,  United States
Wisconsin
      University of Wisconsin, Madison,  Wisconsin,  53792-5132,  United States

Study ID Numbers:  C107
Record last reviewed:  January 2005
Last Updated:  January 7, 2005
Record first received:  July 10, 2003
ClinicalTrials.gov Identifier:  NCT00064623
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08