Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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
Drug: Amitriptyline hydrochloride placebo
Procedure: Point acupuncture

MedlinePlus related topics: AIDS Acupuncture Neurologic Diseases Peripheral Nerve Disorders
Drug Information available for: Amitriptyline Amitriptyline hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Single Group Assignment, 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):

Primary Outcome Measures:
  • 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 ]

Enrollment: 260
Study Start Date: November 1994
Primary Completion Date: July 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive standardized 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.
Drug: Amitriptyline hydrochloride
75 mg oral tablet taken daily
Drug: Amitriptyline hydrochloride placebo
Oral placebo tablet taken daily
Procedure: Point acupuncture
Standardized or alternate acupuncture procedure

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:
Responsible Party: DAIDS ( Rona Siskind )
Study ID Numbers: CPCRA 022
Study First Received: November 2, 1999
Last Updated: September 25, 2008
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 January 15, 2009