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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000817 |
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 | Intervention |
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HIV Infections Peripheral Nervous System Disease |
Drug: Amitriptyline hydrochloride Drug: Amitriptyline hydrochloride placebo Procedure: Point acupuncture |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Single Group Assignment, Efficacy Study |
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 |
Enrollment: | 260 |
Study Start Date: | November 1994 |
Primary Completion Date: | July 1996 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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.
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Drug: Amitriptyline hydrochloride
75 mg oral tablet taken daily
Drug: Amitriptyline hydrochloride placebo
Oral placebo tablet taken daily
Procedure: Point acupuncture
Standardized or alternate acupuncture procedure
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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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment: Required:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded (not applicable for patients at sites using an acupuncture only study design):
Prior Medication:
Excluded within 2 weeks prior to study entry:
United States, California | |
Community Consortium of San Francisco | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
Denver CPCRA / Denver Public Hlth | |
Denver, Colorado, United States, 802044507 | |
United States, District of Columbia | |
Veterans Administration Med Ctr / Regional AIDS Program | |
Washington, District of Columbia, United States, 20422 | |
United States, Maryland | |
Baltimore Trials | |
Baltimore, Maryland, United States, 21201 | |
United States, Michigan | |
Comprehensive AIDS Alliance of Detroit | |
Detroit, Michigan, United States, 48201 | |
United States, New Jersey | |
North Jersey Community Research Initiative | |
Newark, New Jersey, United States, 071032842 | |
United States, New Mexico | |
Partners Research | |
Albuquerque, New Mexico, United States, 871315271 | |
United States, New York | |
Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
Clinical Directors Network of Region II | |
New York, New York, United States, 10011 | |
United States, Oregon | |
Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
Portland, Oregon, United States, 972109951 | |
United States, Pennsylvania | |
Philadelphia FIGHT | |
Philadelphia, Pennsylvania, United States, 19107 |
Study Chair: | Shlay J | |
Study Chair: | Flaws B |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | CPCRA 022 |
Study First Received: | November 2, 1999 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000817 |
Health Authority: | United States: Federal Government |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Peripheral Nervous System Diseases |
Amitriptyline Pain Acupuncture Therapy |
Virus Diseases Sexually Transmitted Diseases, Viral Neuromuscular Diseases HIV Infections Peripheral Nervous System Diseases Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Amitriptyline Pain AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents RNA Virus Infections Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Adrenergic Agents Immune System Diseases Adrenergic Uptake Inhibitors Physiological Effects of Drugs Nervous System Diseases Psychotropic Drugs |
Infection Pharmacologic Actions Antidepressive Agents, Tricyclic Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Lentivirus Infections Peripheral Nervous System Agents Analgesics Central Nervous System Agents Antidepressive Agents |