Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection
HIV Infections, Stomatitis, Aphthous
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Thalidomide, Stomatitis, Aphthous
Eligibility Criteria
Inclusion Criteria 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. 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.
Sites / Locations
- Univ of Alabama at Birmingham
- Univ of Southern California / LA County USC Med Ctr
- San Francisco AIDS Clinic / San Francisco Gen Hosp
- Stanford at Kaiser / Kaiser Permanente Med Ctr
- Harbor UCLA Med Ctr
- Univ of Colorado Health Sciences Ctr
- Howard Univ
- Univ of Miami School of Medicine
- Queens Med Ctr
- Univ of Hawaii
- Northwestern Univ Med School
- Cook County Hosp
- Rush Presbyterian - Saint Luke's Med Ctr
- Louis A Weiss Memorial Hosp
- Illinois Masonic Med Ctr
- Indiana Univ Hosp
- Harvard (Massachusetts Gen Hosp)
- Beth Israel Deaconess - West Campus
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
- Comprehensive Health Care Ctr / Bronx Municipal Hosp
- Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
- Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
- Montefiore Family Health Ctr / Bronx Municipal Hosp
- Jack Weiler Hosp / Bronx Municipal Hosp
- Montefiore Med Ctr / Bronx Municipal Hosp
- North Central Bronx Hosp / Bronx Municipal Hosp
- Bronx Veterans Administration / Mount Sinai Hosp
- SUNY / Erie County Med Ctr at Buffalo
- Beth Israel Med Ctr
- Bellevue Hosp / New York Univ Med Ctr
- Mount Sinai Med Ctr / Pediatrics
- Mount Sinai Med Ctr
- SUNY / State Univ of New York
- Univ of North Carolina
- Case Western Reserve Univ
- Milton S Hershey Med Ctr
- Thomas Jefferson Univ Hosp
- Meharry Med College
- Univ of Washington
- Univ of Puerto Rico