- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000790
Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection
PRIMARY: To evaluate the effectiveness and safety of thalidomide for treatment of oral and esophageal aphthous ulcers (those unrelated to a known infection or malignancy) in patients with advanced HIV disease. To evaluate the effect of thalidomide on HIV load in this patient population. Per 06/28/94 amendment, to evaluate the effectiveness of thalidomide in preventing recurrences in patients whose aphthae completely heal at the end of acute treatment.
SECONDARY: To evaluate the effect of thalidomide on blood tumor necrosis factor (TNF) levels and to obtain pharmacokinetic data on the drug. Per 06/28/94 amendment, to evaluate the safety of thalidomide. Per 05/10/95 amendment, to explore in a substudy the effects of thalidomide on idiopathic genital aphthous ulcers in HIV-infected women.
Aphthous ulcers of the mouth or esophagus can interfere with eating, resulting in malnutrition and wasting. Thalidomide has been proposed as an effective therapy for severe forms of aphthous ulceration in AIDS patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aphthous ulcers of the mouth or esophagus can interfere with eating, resulting in malnutrition and wasting. Thalidomide has been proposed as an effective therapy for severe forms of aphthous ulceration in AIDS patients.
Patients are randomized to receive 4 weeks of either thalidomide or placebo orally, administered once daily. Patients are followed weekly. Complete responders after 4 weeks of acute treatment enter a 24-week maintenance phase. A pharmacokinetic substudy will be included.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico
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Alabama
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Birmingham, Alabama, United States, 35294
- Univ of Alabama at Birmingham
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California
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Los Angeles, California, United States, 900331079
- Univ of Southern California / LA County USC Med Ctr
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San Francisco, California, United States, 941102859
- San Francisco AIDS Clinic / San Francisco Gen Hosp
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San Francisco, California, United States, 94115
- Stanford at Kaiser / Kaiser Permanente Med Ctr
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Torrance, California, United States, 90502
- Harbor UCLA Med Ctr
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Colorado
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Denver, Colorado, United States, 80262
- Univ of Colorado Health Sciences Ctr
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District of Columbia
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Washington, District of Columbia, United States, 20059
- Howard Univ
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Florida
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Miami, Florida, United States, 331361013
- Univ of Miami School of Medicine
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Hawaii
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Honolulu, Hawaii, United States, 96816
- Univ of Hawaii
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Honolulu, Hawaii, United States, 96816
- Queens Med Ctr
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Univ Med School
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Chicago, Illinois, United States, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Chicago, Illinois, United States, 60612
- Cook County Hosp
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Chicago, Illinois, United States, 60640
- Louis A Weiss Memorial Hosp
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Chicago, Illinois, United States, 606575147
- Illinois Masonic Med Ctr
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Indiana
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Indianapolis, Indiana, United States, 462025250
- Indiana Univ Hosp
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Harvard (Massachusetts Gen Hosp)
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess - West Campus
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New York
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Bronx, New York, United States, 10461
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
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Bronx, New York, United States, 10465
- Jack Weiler Hosp / Bronx Municipal Hosp
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Bronx, New York, United States, 10467
- Montefiore Med Ctr / Bronx Municipal Hosp
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Bronx, New York, United States, 10468
- Bronx Veterans Administration / Mount Sinai Hosp
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Bronx, New York, United States, 10461
- Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
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Bronx, New York, United States, 10461
- Montefiore Family Health Ctr / Bronx Municipal Hosp
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Bronx, New York, United States, 10467
- North Central Bronx Hosp / Bronx Municipal Hosp
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Bronx, New York, United States, 10461
- Comprehensive Health Care Ctr / Bronx Municipal Hosp
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Bronx, New York, United States, 10461
- Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
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Buffalo, New York, United States, 14215
- SUNY / Erie County Med Ctr at Buffalo
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New York, New York, United States, 10003
- Beth Israel Med Ctr
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New York, New York, United States, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, United States, 10029
- Mount Sinai Med Ctr
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New York, New York, United States, 10029
- Mount Sinai Med Ctr / Pediatrics
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Syracuse, New York, United States, 13210
- SUNY / State Univ of New York
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North Carolina
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Chapel Hill, North Carolina, United States, 275997215
- Univ of North Carolina
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Ohio
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Cleveland, Ohio, United States, 44106
- Case Western Reserve Univ
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Pennsylvania
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Hershey, Pennsylvania, United States, 170330850
- Milton S Hershey Med Ctr
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Philadelphia, Pennsylvania, United States, 191075098
- Thomas Jefferson Univ Hosp
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Tennessee
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Nashville, Tennessee, United States, 37203
- Meharry Med College
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Washington
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Seattle, Washington, United States, 981224304
- Univ of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
- Anti-HIV therapy provided therapy has remained constant in the 4 weeks prior to study entry.
- Narcotic analgesia after the first week of treatment ONLY IF the patient is not experiencing somnolence.
Patients must have:
- Documented HIV infection or AIDS.
- Biopsy-confirmed aphthous ulceration of the mouth or esophagus lasting at least 2 weeks.
- Negative culture of ulcer for Herpes simplex.
- En face diameter of >= 5 mm for largest aphthous ulcer.
- Life expectancy of at least 3 months.
NOTE:
- This study is approved for prisoner participation.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Known allergy to thalidomide.
- Grade 2 or worse bilateral peripheral neuropathy.
EXCLUDED FOR MAINTENANCE PHASE:
- Toxicity other than somnolence in acute phase that required discontinuation of drug.
Concurrent Medication:
Excluded:
- Acute therapy for opportunistic infection.
- ddC.
- Pentoxifylline.
- Methotrexate, trimetrexate, antineoplastic alkylating agents.
- Other putative immunomodulators.
- CNS depressants and/or medications with sedative or hypnotic effect.
- Systemic and/or oral topical corticosteroids.
- Systemic chemotherapy for Kaposi's sarcoma or other malignancies.
- Compounded antibacterial mouthwashes containing anti-infective agents (such as doxycycline, minocycline, tetracycline, or nystatin).
Concurrent Treatment:
Excluded:
- Radiation to head and/or neck.
Patients with the following prior conditions are excluded:
- History of grade 2 or worse bilateral peripheral neuropathy.
- Change in anti-HIV therapy within 4 weeks prior to study entry.
- Prior enrollment in ACTG 251 or prior treatment of aphthous ulcers with thalidomide.
Prior Medication:
Excluded:
- Systemic and/or oral topical corticosteroids within 1 week prior to first set of bloods drawn.
- Other putative immunomodulators within 2 weeks prior to study entry.
- Prior thalidomide for aphthous ulcers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Jacobson JM
Publications and helpful links
General Publications
- Jacobson JM, Greenspan JS, Spritzler J, Ketter N, Fahey JL, Jackson JB, Fox L, Chernoff M, Wu AW, MacPhail LA, Vasquez GJ, Wohl DA. Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group. N Engl J Med. 1997 May 22;336(21):1487-93. doi: 10.1056/NEJM199705223362103.
- Jacobson JM, Spritzler J, Fox L, Fahey JL, Jackson JB, Chernoff M, Wohl DA, Wu AW, Hooton TM, Sha BE, Shikuma CM, MacPhail LA, Simpson DM, Trapnell CB, Basgoz N. Thalidomide for the treatment of esophageal aphthous ulcers in patients with human immunodeficiency virus infection. National Institute of Allergy and Infectious Disease AIDS Clinical Trials Group. J Infect Dis. 1999 Jul;180(1):61-7. doi: 10.1086/314834.
- Gilden D. Thalidomide and aphthous ulcers. GMHC Treat Issues. 1995 Nov;9(11):12.
- Jacobson JM, Greenspan JS, Spritzler J, Fox L, Fahey JL, Jackson JB, Chernoff M, Wohl DA, Pulvirenti JJ, Hooton TM, Shikuma C. Thalidomide in low intermittent doses does not prevent recurrence of human immunodeficiency virus-associated aphthous ulcers. J Infect Dis. 2001 Jan 15;183(2):343-346. doi: 10.1086/317928. Epub 2000 Dec 15.
- Aweeka F, Trapnell C, Chernoff M, Jayewardene A, Spritzler J, Bellibas SE, Lizak P, Jacobson J. Pharmacokinetics and pharmacodynamics of thalidomide in HIV patients treated for oral aphthous ulcers: ACTG protocol 251. AIDS Clinical Trials Group. J Clin Pharmacol. 2001 Oct;41(10):1091-7. doi: 10.1177/00912700122012698.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease Attributes
- Stomatognathic Diseases
- Mouth Diseases
- Sepsis
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
- Viremia
- Stomatitis
- Stomatitis, Aphthous
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Thalidomide
Other Study ID Numbers
- ACTG 251
- 11228 (Registry Identifier: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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