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
HIV Infections, Peripheral Nervous System Disease
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Peripheral Nervous System Diseases, Amitriptyline, Pain, Acupuncture Therapy
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.
Sites / Locations
- Community Consortium of San Francisco
- Denver CPCRA / Denver Public Hlth
- Veterans Administration Med Ctr / Regional AIDS Program
- Baltimore Trials
- Comprehensive AIDS Alliance of Detroit
- North Jersey Community Research Initiative
- Partners Research
- Clinical Directors Network of Region II
- Harlem AIDS Treatment Group / Harlem Hosp Ctr
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
- Philadelphia FIGHT
Arms of the Study
Arm 1
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.