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

Completed · Not applicable · Has a placebo group

Conditions studied: HIV Infections, Peripheral Nervous System Disease

In brief

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.

Key facts

Study ID

NCT00000817

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

260

Starts

1994-11-01

Expected to finish

1997-05-01

Last updated by the study team

2021-11-03

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Community Consortium of San Francisco — San Francisco, California, United States
• Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
• Veterans Administration Med Ctr / Regional AIDS Program — Washington D.C., District of Columbia, United States
• Baltimore Trials — Baltimore, Maryland, United States
• Comprehensive AIDS Alliance of Detroit — Detroit, Michigan, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Partners Research — Albuquerque, New Mexico, United States
• Clinical Directors Network of Region II — New York, New York, United States
• Harlem AIDS Treatment Group / Harlem Hosp Ctr — New York, New York, United States
• Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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