HIV InfectionsNCT00000817
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
A study testing Amitriptyline hydrochloride and Point acupuncture in people with HIV Infections and Peripheral Nervous System Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Peripheral Nervous System Disease
- What is being tested?
- Amitriptyline hydrochloride and Point acupuncture
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 1994to May 1997
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Partners Research
Albuquerque, New Mexico, 87131
Baltimore Trials
Baltimore, Maryland, 21201
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 80204
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201
Clinical Directors Network of Region II
New York, New York, 10011
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037
North Jersey Community Research Initiative
Newark, New Jersey, 07103
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
Community Consortium of San Francisco
San Francisco, California, 94110
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422
About this study
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.
Read the detailed 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.
- Conditions
- HIV Infections, Peripheral Nervous System Disease
- Being tested
- Amitriptyline hydrochloride, Amitriptyline hydrochloride placebo, Point acupuncture
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Peripheral Nervous System Diseases, Amitriptyline, Pain, Acupuncture Therapy
- Medical subject headings
- HIV Infections, Peripheral Nervous System Diseases, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amitriptyline hydrochlorideDrug
75 mg oral tablet taken daily
Amitriptyline hydrochloride placeboDrug
Oral placebo tablet taken daily
Point acupunctureProcedure or surgery
Standardized or alternate acupuncture procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Amitriptyline hydrochloride; Drug: Amitriptyline hydrochloride placebo; Procedure: Point acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intensity of pain as measured by the daily pain diary and the global pain relief rating
Measured: At Weeks 6 and 14
Change in quality life
Measured: Throughout study
Change in neurological status
Measured: Throughout study
Permanent discontinuation of study treatment due to treatment failure
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startNov 1994
- Study completionMay 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Shlay J, Study chairFlaws B, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000817
- Sponsor's protocol ID
- CPCRA 022
- Other IDs
- 11572
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 3 Nov 2021
- Results posted
- No
Publications
Chavez C. Prickly business. The finer points of acupuncture. Posit Aware. 1995 Jan-Feb:14-5.
PubMed 11362204Shlay 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. doi: 10.1001/jama.280.18.1590.
PubMed 9820261
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00000817
- Acronym / sponsor ID
- CPCRA 022
- Conditions
- HIV Infections, Peripheral Nervous System Disease
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Peripheral Nervous System Diseases, Amitriptyline, Pain, Acupuncture Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 1994
- Study completion
- May 1997 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Amitriptyline hydrochloride, Drug: Amitriptyline hydrochloride placebo, Procedure: Point acupunctureParticipants 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Antiretroviral therapy.
- Nonsystemic treatment of Kaposi's sarcoma.
- Maintenance with an existing regimen of analgesic medication or herbal treatment.
- Acupuncture.
- HIV infection.
Key exclusion criteria (17 listed)
- 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.
- Active treatment for an acute opportunistic infection or malignancy (nonsystemic treatment of Kaposi's sarcoma is permitted).
- Other tricyclic antidepressants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amitriptyline hydrochloride75 mg oral tablet taken daily | Drug | 1 |
| Amitriptyline hydrochloride placeboOral placebo tablet taken daily | Drug | 1 |
| Point acupunctureStandardized or alternate acupuncture procedure | Procedure or surgery | 1 |
Primary outcome
Change in intensity of pain as measured by the daily pain diary and the global pain relief rating
Time frame: At Weeks 6 and 14
Change in quality life
Time frame: Throughout study
Change in neurological status
Time frame: Throughout study
Permanent discontinuation of study treatment due to treatment failure
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Background: PubMed 11362204Chavez C. Prickly business. The finer points of acupuncture. Posit Aware. 1995 Jan-Feb:14-5.
- Background: PubMed 9820261Shlay 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. doi: 10.1001/jama.280.18.1590.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlay J study chair
Flaws B study chair
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amitriptyline hydrochloride and Point acupuncture in people with HIV Infections and Peripheral Nervous System Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intensity of pain as measured by the daily pain diary and the global pain relief rating (time frame: At Weeks 6 and 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000817, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.