HIV Infections, Pain, Peripheral Nervous System Diseases
Conditions
Keywords
Dermal assessment, Pain measurement, Diary, Neuropathy, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, HIV Infections/*complications/*drug therapy, Pain, Complementary Therapies
Brief summary
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.
Interventions
Sponsors
NeurogesX
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Countries
United States
Outcome results
None listed