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The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared With Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected Patients

This study is ongoing, but not recruiting participants.
Study NCT00000817.   Last updated on September 25, 2008.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

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Descriptive Information Fields
Brief Title  The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared With Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected Patients
Official Title  The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared With Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected Patients
Brief Summary

To evaluate the separate and combined efficacy of a standardized acupuncture regimen and amitriptyline on the relief of pain due to peripheral neuropathy and on the quality of life of HIV-infected patients.

Both amitriptyline, an antidepressant, and acupuncture, a Chinese medical approach that uses needles to relieve pain, have been used successfully to reduce pain in some people. It is not known how effectively these approaches relieve or reduce pain in patients with peripheral neuropathy secondary to HIV infection.

Detailed Description

Both amitriptyline, an antidepressant, and acupuncture, a Chinese medical approach that uses needles to relieve pain, have been used successfully to reduce pain in some people. It is not known how effectively these approaches relieve or reduce pain in patients with peripheral neuropathy secondary to HIV infection.

Patients are randomized to receive either standardized point acupuncture or alternate point acupuncture treatment twice weekly for the first 6 weeks, then once weekly for the next 8 weeks, plus either oral amitriptyline or placebo daily for the entire 14 weeks. Acupuncture points are located on the lower leg. Patients are evaluated at weeks 6 and 14 and are asked to keep a daily pain diary.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver), Single Group Assignment, Efficacy Study
Primary Outcome Measure  Change in intensity of pain as measured by the daily pain diary and the global pain relief rating [ Time Frame: At Weeks 6 and 14 ] [ Designated as safety issue: No ]
Change in quality life [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Change in neurological status [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Permanent discontinuation of study treatment due to treatment failure [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  HIV Infections
Peripheral Nervous System Disease
Intervention  Drug: Amitriptyline hydrochloride
Drug: Amitriptyline hydrochloride placebo
Procedure: Point acupuncture
MEDLINE PMIDs 11362204,   9820261
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  260
Start Date  November 1994
Completion Date
Eligibility Criteria 

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antiretroviral therapy.
  • Nonsystemic treatment of Kaposi's sarcoma.
  • Maintenance with an existing regimen of analgesic medication or herbal treatment.

Concurrent Treatment: Required:

  • Acupuncture.

Patients must have:

  • HIV infection.
  • Lower extremity peripheral neuropathy secondary to HIV infection.
  • Pain for at least 2 weeks prior to study entry.
  • Life expectancy of at least 6 months.

NOTE:

  • Co-enrollment in other experimental protocols is permitted as long as dual participation is allowed in those protocols.

Prior Medication:

Allowed:

  • Antiretroviral therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Known allergy to amitriptyline (not applicable for patients at sites using an acupuncture only study design).
  • EKG indicating malignant arrhythmia or cardiac conduction disturbances (not applicable for patients at sites using an acupuncture only study design).
  • Prison incarceration.

Concurrent Medication:

Excluded:

  • Active treatment for an acute opportunistic infection or malignancy (nonsystemic treatment of Kaposi's sarcoma is permitted).
  • Other tricyclic antidepressants.
  • MAO inhibitors.

Patients with the following prior conditions are excluded (not applicable for patients at sites using an acupuncture only study design):

  • History of cardiac disease.
  • History of seizure disorder.

Prior Medication:

Excluded within 2 weeks prior to study entry:

  • MAO inhibitors.
  • Tricyclic antidepressants.
Gender Both
Ages 13 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000817
Organization ID CPCRA 022
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ††
Investigators 
Study Chair:     Shlay J        
Study Chair:     Flaws B        
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date September 2008
First Received Date  November 2, 1999
Last Updated Date September 25, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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