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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000793 |
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.
Condition | Intervention | Phase |
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HIV Infections Peripheral Nervous System Disease |
Drug: Mexiletine hydrochloride Drug: Benztropine mesylate Drug: Amitriptyline hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection |
Estimated Enrollment: | 240 |
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 amitriptyline and mexiletine. Doses are gradually increased over 4 weeks until a minimum effective dose or MTD is reached, then patients are treated for at least 4 additional weeks at the final dose before gradually tapering off. Neurologic exams are performed at screening and at the end of treatment. Intensity of pain is rated twice daily by the patient. Patients are followed at Weeks 2, 4, and 8, and at 10 days after completely tapering off of drug.
PER 3/16/95 AMENDMENT: Patients with no pain relief 14 days after initiation of study therapy may have dose doubled or increased to maximum allowable dose, whichever is lower. Then if no improvement occurs within 14 days after dose increase, patients have the option of discontinuing study medication.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
NOTE:
Concurrent Treatment:
Allowed:
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:
Prior Medication:
Excluded:
Per 3/16/95 amendment:
Risk Behavior:
Excluded:
Study Chair: | K Kieburtz | |
Study Chair: | D Simpson |
Study ID Numbers: | ACTG 242 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000793 |
Health Authority: | United States: Federal Government |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Peripheral Nervous System Diseases Amitriptyline |
Pain Mexiletine benzatropine methanesulfonate Parasympatholytics |
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Mexiletine AIDS-Related Complex Pain Immunologic Deficiency Syndromes Virus Diseases Dopamine |
Neuromuscular Diseases HIV Infections Peripheral Nervous System Diseases Sexually Transmitted Diseases Amitriptyline Retroviridae Infections Benztropine |
Dopamine Uptake Inhibitors Parasympatholytics Communicable Diseases Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Slow Virus Diseases Cholinergic Antagonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Infection Sensory System Agents Therapeutic Uses Anti-Arrhythmia Agents Analgesics Antidepressive Agents RNA Virus Infections Immune System Diseases Nervous System Diseases Cardiovascular Agents Pharmacologic Actions Antidepressive Agents, Tricyclic Muscarinic Antagonists Autonomic Agents Analgesics, Non-Narcotic |