Evaluation of a TNF-Alpha Modulator for the Treatment of Oral Lesions in HIV/AIDS Patients
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
960095
NCT00001524
June 1996
December 2004
Name | Location |
---|---|
National Institute of Dental And Craniofacial Research (NIDCR) | Bethesda, Maryland 20892 |