NCT00061152

Brief Summary

The purpose of the study is to gain initial information on the tolerability and feasibility of high-concentration capsaicin patches for the treatment of painful HIV-associated neuropathy, whether resulting from HIV disease and/or antiretroviral drug exposure. The study will also provide preliminary safety and efficacy information.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2003

Completed
Last Updated

September 14, 2007

Status Verified

September 1, 2007

First QC Date

May 21, 2003

Last Update Submit

September 12, 2007

Conditions

HIV Infections

Keywords

Pain MeasurementDiaryPainful HIV NeuropathyHIV NeuropathyCapsaicinAnalgesics/*therapeutic useCapsaicin/*administration & dosage/adverse effectsPeripheral Nervous System Diseases/*complications/diagnosis/*therapyPeripheral Nervous System Diseases/drug therapy/*etiology/physiopathologyPain

Interventions

Capsaicin Dermal PatchDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 18 and 75 years of age.
  • Documented evidence of HIV-1 infection.
  • Painful HIV-associated neuropathy, whether 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:
  • Diminished ankle reflexes (compared to the knee) or absent ankle reflexes,
  • AND/OR
  • Distal diminution of either vibration sensation or pain or temperature sensation in the legs.
  • Either no neurotoxic antiretroviral (i.e., didanosine \[ddI\], zalcitabine \[ddC\], or stavudine \[d4T\]) exposure for at least 8 weeks prior to Screening Visit,
  • Currently on stable dose(s) of any of the neurotoxic antiretrovirals listed above for at least 8 weeks prior to Screening Visit, without a foreseeable need to change doses or medications for duration of study.
  • Screening Pain Sum Score of 12 to 36.
  • 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 7 days prior to Treatment Visit (Day 0) and willing to maintain medications at same stable dose(s) and schedule throughout the study.
  • Be willing and able to use Roxicodone® (oxycodone) oral solution, if needed, to relieve treatment-associated discomfort.
  • Female subjects with child-bearing potential must have a negative urine or serum pregnancy test, to be performed at the Screening Visit.
  • All subjects must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study and for 30 days following experimental drug exposure.
  • +1 more criteria

You may not qualify if:

  • 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.
  • Significant pain of an etiology other than painful HIV-associated neuropathy, for example, compression-related neuropathies, e.g., spinal stenosis, or fibromyalgia or arthritis. Subjects must not have 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, hereditary neuropathy, vitamin B12 deficiency (B12 level less than or equal to 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.
  • Recent use (within 21 days preceding the Treatment Visit \[Day 0\]) 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.
  • Treatment for acute opportunistic infections within 14 days before Treatment Visit (Day 0). Maintenance treatment of cytomegalovirus (CMV) retinitis, Mycobacterium avium bacteremia, or cryptococcal meningitis is permitted.
  • Current use of any investigational drug, or Class 1 anti-arrhythmic drugs (such as tocainide and mexiletine).
  • Hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, Roxicodone or adhesives.
  • 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.
  • Currently have active malignant disease. Malignancies in remission that do not require further treatment or Kaposi's sarcoma requiring local treatment only are allowed.
  • High tolerance to opioids that precludes the ability to relieve treatment-associated discomfort with Roxicodone® if needed, as judged by investigator.
  • History or current problem with prescription drug, illicit substance, or alcohol abuse from self report or as judged by investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NeurogesX Investigational Site

West Hollywood, California, 90069, United States

Location

NeurogesX Investigational Site

New York, New York, 10029, United States

Location

NeurogesX Investigational Site

Portland, Oregon, 97209, United States

Location

MeSH Terms

Conditions

HIV InfectionsPain

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 21, 2003

First Posted

May 22, 2003

Last Updated

September 14, 2007

Record last verified: 2007-09

Locations

US(3)