Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection
Status:
Completed
Trial end date:
1998-10-01
Target enrollment:
Participant gender:
Summary
PRIMARY: To evaluate the effectiveness and safety of thalidomide for treatment of oral and
esophageal aphthous ulcers (those unrelated to a known infection or malignancy) in patients
with advanced HIV disease. To evaluate the effect of thalidomide on HIV load in this patient
population. Per 06/28/94 amendment, to evaluate the effectiveness of thalidomide in
preventing recurrences in patients whose aphthae completely heal at the end of acute
treatment.
SECONDARY: To evaluate the effect of thalidomide on blood tumor necrosis factor (TNF) levels
and to obtain pharmacokinetic data on the drug. Per 06/28/94 amendment, to evaluate the
safety of thalidomide. Per 05/10/95 amendment, to explore in a substudy the effects of
thalidomide on idiopathic genital aphthous ulcers in HIV-infected women.
Aphthous ulcers of the mouth or esophagus can interfere with eating, resulting in
malnutrition and wasting. Thalidomide has been proposed as an effective therapy for severe
forms of aphthous ulceration in AIDS patients.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)