A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection

Completed · Phase 2

Conditions studied: HIV Infections, Peripheral Nervous System Disease

In brief

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.

Key facts

Study ID

NCT00000793

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

240

Expected to finish

1997-10-01

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• 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.

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.
• 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.

Where it is running

• Alabama Therapeutics CRS — Birmingham, Alabama, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Howard University Hosp., Div. of Infectious Diseases, ACTU — Washington D.C., District of Columbia, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• The Ponce de Leon Ctr. CRS — Atlanta, Georgia, United States
• Queens Med. Ctr. — Honolulu, Hawaii, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Cook County Hosp. CORE Ctr. — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Weiss Memorial Hosp. — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
• Univ. of Iowa Healthcare, Div. of Infectious Diseases — Iowa City, Iowa, United States
• Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU — New Orleans, Louisiana, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• Beth Israel Deaconess - East Campus A0102 CRS — Boston, Massachusetts, United States
• Hennepin County Med. Ctr., Div. of Infectious Diseases — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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