A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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.
Patients are randomized to receive amitriptyline, mexiletine, or benztropine mesylate as an active placebo to mimic the mild side effects associated with both...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- 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:
- • Documented HIV infection.
- • Painful peripheral neuropathy.
- NOTE:
- • Patients in ACTG blinded studies of dideoxynucleosides such as ddI, ddC, and d4T are encouraged to enroll in this study.
- Prior Medication:
- Allowed:
- • Prior ddI, ddC, d4T, or 3TC, if on a stable dose for at least 8 weeks prior to study entry.
- • Prior cimetidine if on a stable dose for at least 2 weeks prior to study entry.
- • Exclusion Criteria
- 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.
- • Flecainide acetate.
- • Encainide.
- • Lidocaine.
- • Cisplatin.
- • Vincristine.
- • Chloramphenicol, disulfiram, ethionamide glutethimide, gold, hydralazine, iodoquinol, metronidazole, nitrofurantoin, or ribavirin (only in patients in whom the onset or clear worsening of painful peripheral neuropathy was attributed to previously taking these drugs).
- • Any investigational drugs other than 3TC (except with permission of the protocol team).
- • Terfenadine (if concurrent with ketoconazole).
- Patients with the following prior conditions are excluded:
- • Documented history of cardiac disease.
- • History of allergy to, or intolerance of, tricyclic antidepressants, mexiletine, or benztropine.
- Prior Medication:
- Excluded:
- • Prior disopyramide.
- • Prior procainamide.
- • Prior quinidine.
- • Prior tocainide.
- • Prior flecainide acetate.
- • Prior encainide.
- • Prior lidocaine.
- • Cisplatin or vincristine within 8 weeks prior to study entry.
- • Chloramphenicol, disulfiram, ethionamide glutethimide, gold, hydralazine, iodoquinol, metronidazole, nitrofurantoin, or ribavirin within 8 weeks prior to study entry (only in patients in whom the onset or clear worsening of painful peripheral neuropathy was attributed to taking these drugs).
- • Any MAO inhibitor antidepressants, any tricyclic or tetracyclic antidepressants, certain serotonin re-uptake inhibitors (fluoxetine, paroxetine, and venlafaxine), or mexiletine, within 4 weeks prior to study entry.
- • More than 50 percent change in the weekly dosage of any pain control medications within 2 weeks prior to study entry.
- Per 3/16/95 amendment:
- • ddI, ddC, d4T, or 3TC within 8 weeks prior to study entry ONLY IF dideoxynucleoside dosing was suspended or permanently discontinued.
- Risk Behavior:
- Excluded:
- • Active drug or alcohol abuse.
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Washington, District Of Columbia, United States
Miami, Florida, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Minneapolis, Minnesota, United States
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
Buffalo, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Seattle, Washington, United States
Mbeya, , Tanzania
Chicago, Illinois, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Patients applied
Trial Officials
K Kieburtz
Study Chair
D Simpson
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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