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A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection Clinical research trials and A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection. A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection clinical trial. Subjects frequently get the best healthcare possible for their A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.

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



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

For Condition: HIV Infections,Peripheral Nervous System Disease
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Boehringer Ingelheim Pharmaceuticals
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 240

Location and Contact Information:

Overall Study Official:
KKieburtz,  Study Chair, 

VA Hosp at San Diego / Pediatrics
San Diego,  California,  92161
United States
 

SUNY / State Univ of New York
Syracuse,  New York,  13210
United States
 

Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco,  California,  941102859
United States
 

Charity Hosp / Tulane Univ Med School
New Orleans,  Louisiana,  70112
United States
 

North Central Bronx Hosp / Bronx Municipal Hosp
Bronx,  New York,  10467
United States
 

Rush Presbyterian - Saint Luke's Med Ctr
Chicago,  Illinois,  60612
United States
 

Univ of Washington
Seattle,  Washington,  981224304
United States
 

Queens Med Ctr
Honolulu,  Hawaii,  96816
United States
 

Georgetown Univ Med Ctr
Washington D.C.,  District of Columbia,  20007
United States
 

Case Western Reserve Univ
Cleveland,  Ohio,  44106
United States
 

Columbia Presbyterian Med Ctr
New York City,  New York,  100323784
United States
 

Cook County Hosp
Chicago,  Illinois,  60612
United States
 

Illinois Masonic Med Ctr
Chicago,  Illinois,  606575147
United States
 

SUNY / Erie County Med Ctr at Buffalo
Buffalo,  New York,  14215
United States
 

Univ of Minnesota
Minneapolis,  Minnesota,  55455
United States
 

Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Julio Arroyo
West Columbia,  South Carolina,  29169
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

San Francisco Gen Hosp
San Francisco,  California,  941102859
United States
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 

Univ of Miami School of Medicine
Miami,  Florida,  331361013
United States
 

Univ of Cincinnati
Cincinnati,  Ohio,  452670405
United States
 

Yale Univ / New Haven
New Haven,  Connecticut,  065102483
United States
 

Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx,  New York,  10461
United States
 

Univ of Nebraska Med Ctr
Omaha,  Nebraska,  681985130
United States
 

Univ of Colorado Health Sciences Ctr
Denver,  Colorado,  80262
United States
 

Louis A Weiss Memorial Hosp
Chicago,  Illinois,  60640
United States
 

Harbor UCLA Med Ctr
Torrance,  California,  90502
United States
 

St Paul Ramsey Med Ctr
St. Paul,  Minnesota,  55101
United States
 

Univ of California / San Diego Treatment Ctr
San Diego,  California,  921036325
United States
 

Univ of Iowa Hosp and Clinic
Iowa City,  Iowa,  52242
United States
 

Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx,  New York,  10461
United States
 

Howard Univ
Washington D.C.,  District of Columbia,  20059
United States
 

Methodist Hosp of Indiana / Life Care Clinic
Indianapolis,  Indiana,  46202
United States
 

St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis,  Missouri,  63112
United States
 

UCLA CARE Ctr
Los Angeles,  California,  90095
United States
 

Jack Weiler Hosp / Bronx Municipal Hosp
Bronx,  New York,  10465
United States
 

Beth Israel Deaconess - West Campus
Boston,  Massachusetts,  02215
United States
 

Montefiore Med Ctr / Bronx Municipal Hosp
Bronx,  New York,  10467
United States
 

Northwestern Univ Med School
Chicago,  Illinois,  60611
United States
 

Univ of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Harvard (Massachusetts Gen Hosp)
Boston,  Massachusetts,  02114
United States
 

Univ of North Carolina
Chapel Hill,  North Carolina,  275997215
United States
 

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 

Hennepin County Med Clinic
Minneapolis,  Minnesota,  55415
United States
 

Univ of Pennsylvania at Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 

Thomas Jefferson Univ Hosp
Philadelphia,  Pennsylvania,  191075098
United States
 

Johns Hopkins Hosp
Baltimore,  Maryland,  21287
United States
 

Univ of Hawaii
Honolulu,  Hawaii,  96816
United States
 

Rose Med Ctr
Denver,  Colorado,  80262
United States
 

Meharry Med College
Nashville,  Tennessee,  37203
United States
 

Summitt Med Ctr / San Francisco Gen Hosp
Oakland,  California,  94609
United States
 

Kaiser Permanente Franklin Med Ctr
Denver,  Colorado,  80262
United States
 

Univ of Texas Galveston
Galveston,  Texas,  775550435
United States
 

Emory Univ
Atlanta,  Georgia,  30308
United States
 

Boston Med Ctr
Boston,  Massachusetts,  02118
United States
 


Additional Information:
Study ID Numbers:
  ACTG 242; 
Study Start Date: 
Record last reviewed: December 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000793

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

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