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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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