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

Completed · Phase 2

Conditions studied: HIV Infections, Stomatitis, Aphthous

In brief

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.

Key facts

Study ID

NCT00000790

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

164

Expected to finish

1998-10-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Anti-HIV therapy provided therapy has remained constant in the 4 weeks prior to study entry.
• Narcotic analgesia after the first week of treatment ONLY IF the patient is not experiencing somnolence.
• Patients must have:
• Documented HIV infection or AIDS.
• Biopsy-confirmed aphthous ulceration of the mouth or esophagus lasting at least 2 weeks.
• Negative culture of ulcer for Herpes simplex.
• En face diameter of >= 5 mm for largest aphthous ulcer.
• Life expectancy of at least 3 months.
• NOTE:
• This study is approved for prisoner participation.

You may not qualify if…

• 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:

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• San Francisco AIDS Clinic / San Francisco Gen Hosp — San Francisco, California, United States
• Stanford at Kaiser / Kaiser Permanente Med Ctr — San Francisco, California, United States
• Harbor UCLA Med Ctr — Torrance, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Howard Univ — Washington D.C., District of Columbia, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Queens Med Ctr — Honolulu, Hawaii, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Louis A Weiss Memorial Hosp — Chicago, Illinois, United States
• Illinois Masonic Med Ctr — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
• Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
• SUNY / Erie County Med Ctr at Buffalo — Buffalo, New York, United States
• Beth Israel Med Ctr — New York, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Mount Sinai Med Ctr / Pediatrics — New York, New York, United States
• Mount Sinai Med Ctr — New York, New York, United States
• SUNY / State Univ of New York — Syracuse, New York, United States
• Bronx Municipal Hosp Ctr/Jacobi Med Ctr — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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