HIV Infection Clinical Trial
Official title:
Evaluation of a TNF-Alpha Modulator for the Treatment of Oral Lesions in HIV/AIDS Patients
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 thalidomide can cause drowsiness, skin rashes, allergic reactions, increased
viral load, and even nerve damage that may not be reversible. This study will evaluate the
efficacy of a topical formulation of thalidomide (placed directly on the surface of the
sore) for the healing of these sores.
Persons with HIV infection of acquired immunodeficiency of at least 18 years of age with one
or more chronic, painful intraoral lesions may be eligible for this study. Subjects must be
referred by a primary care physician who is managing their care, and must have HIV/AIDS
status confirmed. Patients' HIV treatment regimen will not be altered and those receiving
highly active therapy will not be excluded.
Patients will be excluded if they are concurrently being treated for mucosal lesions
(including topical or systemic steroids, viscous lidocaine, topical or systemic
anti-fungals, or mouthwashes), or concurrent thalidomide therapy; receving chemotherapy or
radiation therapy for neoplasms; using concurrent acute therapy for opportunistic
infections; 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; pregnant
or lactating females or those not practicing contraception according to FDA guidelines for
thalidomide.
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 administration of thalidomide, topical administration of thalidomide, and placebo. The dose of thalidomide will be determined in a dose escalation pilot study prior to the main study. Healing, pain, and the incidence of side effects will be assessed at baseline and weekly for up to eight weeks. Successful demonstration of an enhanced therapeutic effect or reduced toxicity may provide a basis for the development of novel routes of administration and drugs for the treatment of painful oral lesions associated with HIV infection and other diseases. ;
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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