Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following symptoms or conditions are excluded:
• •Known allergy to thalidomide.
• •Grade 2 or worse bilateral peripheral neuropathy.
• •EXCLUDED FOR MAINTENANCE PHASE:
• •Toxicity other than somnolence in acute phase that required discontinuation of drug.
• •Concurrent Medication:
• •Excluded:
• •Acute therapy for opportunistic infection.
• •ddC.
• •Pentoxifylline.
• •Methotrexate, trimetrexate, antineoplastic alkylating agents.
• •Other putative immunomodulators.
• •CNS depressants and/or medications with sedative or hypnotic effect.
• •Systemic and/or oral topical corticosteroids.
• •Systemic chemotherapy for Kaposi's sarcoma or other malignancies.
• •Compounded antibacterial mouthwashes containing anti-infective agents (such as doxycycline, minocycline, tetracycline, or nystatin).
• •Concurrent Treatment:
• •Excluded:
• •Radiation to head and/or neck.
• •Patients with the following prior conditions are excluded:
• •History of grade 2 or worse bilateral peripheral neuropathy.
• •Change in anti-HIV therapy within 4 weeks prior to study entry.
• •Prior enrollment in ACTG 251 or prior treatment of aphthous ulcers with thalidomide.
• •Prior Medication:
• •Excluded:
• •Systemic and/or oral topical corticosteroids within 1 week prior to first set of bloods drawn.
• •Other putative immunomodulators within 2 weeks prior to study entry.
• •Prior thalidomide for aphthous ulcers.