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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.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000817
  Purpose

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.


Condition Intervention
HIV Infections
Peripheral Nervous System Disease
Drug: Amitriptyline hydrochloride

MedlinePlus related topics:   AIDS    Acupuncture    Neurologic Diseases    Peripheral Nerve Disorders   

ChemIDplus related topics:   Amitriptyline    Amitriptyline hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Efficacy Study
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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   260

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.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000817

Locations
United States, California
Community Consortium of San Francisco    
      San Francisco, California, United States, 94110
United States, Colorado
Denver CPCRA / Denver Public Hlth    
      Denver, Colorado, United States, 802044507
United States, District of Columbia
Veterans Administration Med Ctr / Regional AIDS Program    
      Washington, District of Columbia, United States, 20422
United States, Maryland
Baltimore Trials    
      Baltimore, Maryland, United States, 21201
United States, Michigan
Comprehensive AIDS Alliance of Detroit    
      Detroit, Michigan, United States, 48201
United States, New Jersey
North Jersey Community Research Initiative    
      Newark, New Jersey, United States, 071032842
United States, New Mexico
Partners Research    
      Albuquerque, New Mexico, United States, 871315271
United States, New York
Harlem AIDS Treatment Group / Harlem Hosp Ctr    
      New York, New York, United States, 10037
Clinical Directors Network of Region II    
      New York, New York, United States, 10011
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp    
      Portland, Oregon, United States, 972109951
United States, Pennsylvania
Philadelphia FIGHT    
      Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Investigators
Study Chair:     Shlay J    
Study Chair:     Flaws B    
  More Information

Publications:

Study ID Numbers:   CPCRA 022
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000817
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Acquired Immunodeficiency Syndrome  
AIDS-Related Complex  
Peripheral Nervous System Diseases  
Amitriptyline
Pain
Acupuncture Therapy

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Neuromuscular Diseases
HIV Infections
Peripheral Nervous System Diseases
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Amitriptyline
Pain
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
RNA Virus Infections
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Immune System Diseases
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Infection
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Lentivirus Infections
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 05, 2008




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