Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Peripheral Nervous System Disease

Eligibility:

All Genders

13+ years

Phase:

NA

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 pat...

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 eff...

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.

Key Trial Info

Start Date :

November 1 1994

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 1997

Estimated Enrollment :

260 Patients enrolled

Trial Details

Trial ID

NCT00000817

Start Date

November 1 1994

End Date

May 1 1997

Last Update

November 3 2021

Active Locations (11)

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Page 1 of 3 (11 locations)

1

Community Consortium of San Francisco

San Francisco, California, United States, 94110

2

Denver CPCRA / Denver Public Hlth

Denver, Colorado, United States, 80204

3

Veterans Administration Med Ctr / Regional AIDS Program

Washington D.C., District of Columbia, United States, 20422

4

Baltimore Trials

Baltimore, Maryland, United States, 21201