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

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.