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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000817
• Other study ID #: CPCRA 022
• Secondary ID: 11572
• Status: Completed
• Phase: N/A
• Start date: November 1994
• Est. completion date: May 1997

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: May 1997
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Nervous System Diseases
• Peripheral Nervous System Disease
• Peripheral Nervous System Diseases

Intervention

Drug:
• Amitriptyline hydrochloride
75 mg oral tablet taken daily
• Amitriptyline hydrochloride placebo
Oral placebo tablet taken daily

Procedure:
• Point acupuncture
Standardized or alternate acupuncture procedure

Locations

Country	Name	City	State
United States	Partners Research	Albuquerque	New Mexico
United States	Baltimore Trials	Baltimore	Maryland
United States	Denver CPCRA / Denver Public Hlth	Denver	Colorado
United States	Comprehensive AIDS Alliance of Detroit	Detroit	Michigan
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	North Jersey Community Research Initiative	Newark	New Jersey
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Community Consortium of San Francisco	San Francisco	California
United States	Veterans Administration Med Ctr / Regional AIDS Program	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chavez C. Prickly business. The finer points of acupuncture. Posit Aware. 1995 Jan-Feb:14-5. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intensity of pain as measured by the daily pain diary and the global pain relief rating		At Weeks 6 and 14
Primary	Change in quality life		Throughout study
Primary	Change in neurological status		Throughout study
Primary	Permanent discontinuation of study treatment due to treatment failure		Throughout study