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.

Condition	Treatment or Intervention
HIV Infections Peripheral Nervous System Disease	Drug: Amitriptyline hydrochloride

Further Study Details: 

Expected Total Enrollment:  260

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  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.

California
      Community Consortium of San Francisco, San Francisco,  California,  94110,  United States
Colorado
      Denver CPCRA / Denver Public Hlth, Denver,  Colorado,  802044507,  United States
District of Columbia
      Veterans Administration Med Ctr / Regional AIDS Program, Washington,  District of Columbia,  20422,  United States
Maryland
      Baltimore Trials, Baltimore,  Maryland,  21201,  United States
Michigan
      Comprehensive AIDS Alliance of Detroit, Detroit,  Michigan,  48201,  United States
New Jersey
      North Jersey Community Research Initiative, Newark,  New Jersey,  071032842,  United States
New Mexico
      Partners Research, Albuquerque,  New Mexico,  871315271,  United States
New York
      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
Oregon
      Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland,  Oregon,  972109951,  United States
Pennsylvania
      Philadelphia FIGHT, Philadelphia,  Pennsylvania,  19107,  United States

Study chairs or principal investigators

Shlay J,  Study Chair
Flaws B,  Study Chair

Study ID Numbers:  CPCRA 022
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000817
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08