Thalidomide to Treat Oral Lesions in HIV-Infected Patients

Launched by NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH (NIDCR) · Nov 3, 1999

Keywords

ClinConnect Summary

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 effective when given systemically, but is accompanied by a high incidence of side effects. Administration of the drug topically onto the lesion should result in high local concentrations within the lesion thereby suppressing tumor necrosis factor which is thought to be related to the size and severity of the lesion. Subjects will be randomly allocated to one of three possible groups: systemic admi...

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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.