|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000817 |
Purpose
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 |
|
HIV Infections Peripheral Nervous System Disease |
Drug: Amitriptyline hydrochloride |
| MedlinePlus related topics: | AIDS Acupuncture Neurologic Diseases Peripheral Nerve Disorders |
| ChemIDplus related topics: | Amitriptyline Amitriptyline hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, 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 |
| Estimated 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.
Eligibility
| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CPCRA 022 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000817 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|
|