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 has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000817
First received: November 2, 1999
Last updated: September 28, 2013
Last verified: September 2013

November 2, 1999
September 28, 2013
November 1994
Not Provided
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00000817 on ClinicalTrials.gov Archive Site
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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
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • HIV Infections
  • Peripheral Nervous System Disease
  • 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
Experimental: 1
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.
Interventions:
  • Drug: Amitriptyline hydrochloride
  • Drug: Amitriptyline hydrochloride placebo
  • Procedure: Point acupuncture

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
May 1997
Not Provided

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000817
CPCRA 022, 11572
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Shlay J
Study Chair: Flaws B
National Institute of Allergy and Infectious Diseases (NIAID)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP