Status:
COMPLETED
Thalidomide to Treat Oral Lesions in HIV-Infected Patients
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Acquired Immunodeficiency Syndrome
Burning Mouth Syndrome
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This study will test the effectiveness of topical thalidomide in healing mouth sores in HIV infected patients. Oral (PO) thalidomide heals these sores at a dose of 200 mg per day. However, PO thalidom...
Detailed Description
The proposed clinical trial will evaluate the efficacy of topically-applied thalidomide as a treatment for painful oral lesions in HIV-infected patients. Limited data suggest that this drug may be eff...
Eligibility Criteria
INCLUSION CRITERIA FOR PATIENTS:
Persons with HIV infection or acquired immunodeficiency of at least 18 years of age with one or more chronic, painful intraoral lesions will constitute the study sample for both studies.
Subjects must be referred by a primary care physician who is managing their care, and must have HIV/AIDS status confirmed and current CD4 status provided by the primary physician.
Patients' HIV treatment regimen will not be altered and those receiving highly active antiretroviral therapy will not be excluded.
EXCLUSION CRITERIA FOR PATIENTS:
Patients will be excluded from participation if taking any concurrent treatment for mucosal lesions (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals, or mouthwashes), prior to concurrent thalidomide therapy, chemotherapy or radiation therapy for neoplasms, concurrent acute therapy for opportunistic infection, concurrent use of sedatives (such as CNS depressants or alcohol use), history of allergy to thalidomide, pre-existing peripheral neuropathy of grade II or higher, and females of childbearing potential.
Pregnant or lactating females will be excluded.
INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
Patients must be between ages 40 to 60 years.
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
Cannot be using prescription or non-prescription medications except birth control.
Cannot have acute or chronic current infections or illness.
Cannot have autoimmune conditions, such as diabetes, lupus, or HIV (must be healthy).
Cannot use within 24 hours: anti-inflammatory drugs or other analgesics.
Cannot use within 24 hours: anti-histamines or allergy medications.
Cannot use within 3 weeks: antidepressants or steroids.
Key Trial Info
Start Date :
June 1 1996
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00001524
Start Date
June 1 1996
End Date
December 1 2004
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892