A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection
2 other identifiers
interventional
240
2 countries
37
Brief Summary
To assess the efficacy, safety, and tolerability of amitriptyline hydrochloride versus mexiletine hydrochloride in reducing pain intensity in patients with HIV-related painful peripheral neuropathy. No large-scale controlled clinical trials of symptomatic therapy for painful HIV-related neuropathy have been attempted. Both amitriptyline and mexiletine have been useful in the management of painful neuropathies; however, both are associated with certain toxicities. In this comparative study of amitriptyline and mexiletine, benztropine mesylate also will be included as an active placebo to mimic the side effects of the study drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
October 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 29, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Aspirin and acetaminophen.
- Nonsteroidal anti-inflammatory agents.
- Opiates.
- Pyridoxine (only if accompanied by isoniazid).
- ddI, ddC, d4T, and 3TC if on a stable dose.
- AZT.
- Cimetidine if on a stable dose.
- NOTE:
- Per 3/16/95 amendment, Lactaid may be taken by lactose-intolerant patients for effects of lactose in placebo capsules.
- Concurrent Treatment:
- Allowed:
- Acupuncture.
- Patients must have:
- +8 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Diabetes mellitus.
- Neurological disease of sufficient severity to confound the evaluation of peripheral neuropathy, such as myelopathy without neuropathy. (NOTE: Patients with both myelopathy AND painful peripheral neuropathy are eligible.)
- Electrocardiogram (EKG) indicating malignant arrhythmia or cardiac conduction disturbances (such as second or third degree AV block, anterior hemi-block, or prolonged QT interval).
- Suicidal thoughts of sufficient severity to require treatment with antidepressant medication.
- Concurrent Medication:
- Excluded:
- Phenytoin or carbamazepine (unless on stable dose for 8 weeks prior to study entry).
- Capsaicin.
- Any MAO inhibitor antidepressants, any tricyclic or tetracyclic antidepressants, certain serotonin re-uptake inhibitors (fluoxetine, paroxetine, and venlafaxine), or mexiletine (except as dispensed for this study).
- Disopyramide.
- Procainamide.
- Quinidine.
- Tocainide.
- +29 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Alabama Therapeutics CRS
Birmingham, Alabama, 35294, United States
UCLA CARE Center CRS
Los Angeles, California, 90095, United States
Ucsd, Avrc Crs
San Diego, California, 921036325, United States
Ucsf Aids Crs
San Francisco, California, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80262, United States
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., District of Columbia, 20059, United States
Univ. of Miami AIDS CRS
Miami, Florida, 331361013, United States
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, United States
Queens Med. Ctr.
Honolulu, Hawaii, 96816, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612, United States
Weiss Memorial Hosp.
Chicago, Illinois, 60640, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 462025250, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202, United States
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, 52242, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114, United States
Bmc Actg Crs
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States
Hennepin County Med. Ctr., Div. of Infectious Diseases
Minneapolis, Minnesota, 55415, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112, United States
Washington U CRS
St Louis, Missouri, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, 681985130, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 13210, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
Unc Aids Crs
Chapel Hill, North Carolina, 275997215, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, 452670405, United States
Case CRS
Cleveland, Ohio, 44106, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
University of Washington AIDS CRS
Seattle, Washington, 98104, United States
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
Mbeya, Tanzania
Related Publications (2)
Lein B. Potential therapy for painful neuropathy. PI Perspect. 1995 May;(no 16):11.
PMID: 11362419BACKGROUNDKieburtz K, Simpson D, Yiannoutsos C, Max MB, Hall CD, Ellis RJ, Marra CM, McKendall R, Singer E, Dal Pan GJ, Clifford DB, Tucker T, Cohen B. A randomized trial of amitriptyline and mexiletine for painful neuropathy in HIV infection. AIDS Clinical Trial Group 242 Protocol Team. Neurology. 1998 Dec;51(6):1682-8. doi: 10.1212/wnl.51.6.1682.
PMID: 9855523BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
K Kieburtz
- STUDY CHAIR
D Simpson
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
October 1, 1997
Last Updated
October 29, 2021
Record last verified: 2021-10