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Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy



Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy

For Condition: HIV Infections,Pain,Peripheral Nervous System Diseases
Status: Recruiting
Sponsor(s): NeurogesX ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 300

Location and Contact Information:

Neurology Clinical Research *Recruiting*
Plantation,  Florida,  33324
United States
Recruiting Francisco  Torres 954-475-8171

East Bay AIDS Center *Recruiting*
Berkeley,  California,  94705
United States
Recruiting Jamie  Mandelke 510-204-1291

Park Nicollet Health Clinic *Recruiting*
Minneapolis,  Minnesota,  55416
United States
Recruiting Meaghan  Morton 952-993-2066

Community Research Initiative of New England *Recruiting*
Boston,  Massachusetts,  02215
United States
Recruiting Karlissa  Foy 617-778-5454

Steinhart Medical Center *Recruiting*
Miami,  Florida,  33133
United States
Recruiting Amy  Leibmann 305-856-2171

University of Kentucky *Recruiting*
Lexington,  Kentucky,  40536
United States
Recruiting Yunanan  Mootoor 859-323-6702

Body Positive *Recruiting*
Phoenix,  Arizona,  85006
United States
Recruiting Gilda  Garza 602-307-5330

University of North Carolina at Chapel Hill *Recruiting*
Chapel Hill,  North Carolina,  27599
United States
Recruiting Wendy  Robertson 919-966-6727

Stanford University Medical Center *Recruiting*
Stanford,  California,  94305
United States
Recruiting Alexandria  Luc 650-724-3792

University of Miami School of Medicine *Recruiting*
Miami,  Florida,  33136
United States
Recruiting Leslie  Thompson 305-243-3838

Central Texas Clinical Research *Recruiting*
Austin,  Texas,  78705
United States
Recruiting Corey  King 512-480-9660

Mount Sinai School of Medicine, Department of Neurology *Recruiting*
New York City,  New York,  10029
United States
Recruiting Mary  George 212-241-0784

First Clinical Research *Recruiting*
San Francisco,  California,  94117
United States
Recruiting Lonnie  Leonard 415-682-2434

AIDS Research Alliance *Recruiting*
West Hollywood,  California,  90069
United States
Recruiting Michele  Vertucci 310-358-2429

Albany Medical Center *Recruiting*
Albany,  New York,  12208
United States
Recruiting Cynthia  Morvillo 518-262-6970

University of Wisconsin *Recruiting*
Madison,  Wisconsin,  53792-5132
United States
Recruiting Joanne  Lubich 608-263-4290

HACRP - University of Hawaii *Recruiting*
Honolulu,  Hawaii,  96816
United States
Recruiting Nancy  Hanks 808-441-1531

The Cooper Health System *Recruiting*
Camden,  New Jersey,  08103-1489
United States
Recruiting Alex  Marr 856-968-7331

Case Western Reserve *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting Ron  Johnson 216-844-3246

Community Research Initiative of New England *Recruiting*
Springfield,  Massachusetts,  01107
United States
Recruiting Laurie  Wojtusik 413-734-2264

Cook County Hospital, Dept. of Neurological Sciences *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Eileen  Simeone 312-572-4578

University of California, San Diego *Recruiting*
San Diego,  California,  92103
United States
Recruiting Will  Toperoff 619-543-4734

Johns Hopkins University *Recruiting*
Baltimore,  Maryland,  21205
United States
Recruiting Kathryn  Carter 410-955-1895

Integra Clinical Research, LLC *Recruiting*
San Antonio,  Texas,  78229
United States
Recruiting Cathy  Kirkland 210-692-9249

The Research and Education Group *Recruiting*
Portland,  Oregon,  97209
United States
Recruiting Erin  Merrifield 503-229-8428

Wayne State University *Recruiting*
Detroit,  Michigan,  48201
United States
Recruiting Kelly  Jia 313-966-9407

IDC Research Initiative *Recruiting*
Altamonte Springs,  Florida,  32071
United States
Recruiting Charmaine  Stiles 407-647-3960

Treasure Coast Infectious Disease Consultants *Recruiting*
Vero Beach,  Florida,  32960
United States
Recruiting Jeff  Mieres 772-978-9556

New York Presbyterian Hospital *Recruiting*
New York City,  New York,  10021
United States
Recruiting Ivanka  Zaprlanov 212-746-2349

Arizona Clinical Research *Recruiting*
Phoenix,  Arizona,  85023
United States
Recruiting Dawn  Allen 602-863-6363

Washington University School of Medicine *Recruiting*
St. Louis,  Missouri,  63108
United States
Recruiting Mary  Gould 314-362-9733

North Dallas Center for AIDS & Clinical Research *Recruiting*
Dallas,  Texas,  75208
United States
Recruiting John  Gonzalez 214-941-4000

Infectious Disease of the Palm Beaches Associates *Recruiting*
North,  Florida,  33408
United States
Recruiting Dora  Vasquez 561-630-1402


Additional Information:
Study ID Numbers:
  C107; 
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064623

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