Search / Trial NCT00000817

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of October 18, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Aids Related Complex Peripheral Nervous System Diseases Amitriptyline Pain Acupuncture Therapy

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...

Gender

ALL

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.

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Denver, Colorado, United States

Washington, District Of Columbia, United States

Detroit, Michigan, United States

Newark, New Jersey, United States

New York, New York, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

San Francisco, California, United States

Portland, Oregon, United States

Baltimore, Maryland, United States

Albuquerque, New Mexico, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0