The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful HIV-associated neuropathy.

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

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 (12 weeks).
• 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.
• Must be at least 18 years old, not pregnant, and be 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.

Florida
      Infectious Disease Associates, Sarasota,  Florida,  34239,  United States; Recruiting
Virginia
      Infectious Diseases Physicians, Annandale,  Virginia,  22003,  United States; Recruiting

Study ID Numbers:  C112
Record last reviewed:  November 2004
Record first received:  June 14, 2004
ClinicalTrials.gov Identifier:  NCT00085761
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10