Evaluation of a TNF-Alpha Modulator for the Treatment of Oral Lesions in HIV/AIDS Patients

Inclusion 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.