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
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Peripheral Nervous System Disease
Intervention: Amitriptyline hydrochloride (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Shlay J, Study Chair
Flaws B, Study Chair
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 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.
Clinical Details
Official title: 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
Study design: Treatment, Double-Blind, Efficacy Study
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 effectively these approaches relieve or reduce pain in patients with peripheral
neuropathy secondary to HIV infection.
Patients are randomized to receive either standardized point acupuncture 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. Acupuncture
points are located on the lower leg. Patients are evaluated at weeks 6 and 14 and are asked
to keep a daily pain diary.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Community Consortium of San Francisco, San Francisco, California 94110, United States
Denver CPCRA / Denver Public Hlth, Denver, Colorado 802044507, United States
Veterans Administration Med Ctr / Regional AIDS Program, Washington, District of Columbia 20422, United States
Baltimore Trials, Baltimore, Maryland 21201, United States
Comprehensive AIDS Alliance of Detroit, Detroit, Michigan 48201, United States
North Jersey Community Research Initiative, Newark, New Jersey 071032842, United States
Partners Research, Albuquerque, New Mexico 871315271, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York 10037, United States
Clinical Directors Network of Region II, New York, New York 10011, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 972109951, United States
Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States
Additional Information
Related publications: Chavez C. Prickly business. The finer points of acupuncture. Posit Aware. 1995 Jan-Feb;:14-5. Shlay JC, Chaloner K, Max MB, Flaws B, Reichelderfer P, Wentworth D, Hillman S, Brizz B, Cohn DL. Acupuncture and amitriptyline for pain due to HIV-related peripheral neuropathy: a randomized controlled trial. Terry Beirn Community Programs for Clinical Research on AIDS. JAMA. 1998 Nov 11;280(18):1590-5.
Last updated: June 23, 2005
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