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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Andrulis Pharmaceuticals |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000790 |
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.
Condition | Intervention | Phase |
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HIV Infections Stomatitis, Aphthous |
Drug: Thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection |
Estimated Enrollment: | 164 |
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.
Patients are randomized to receive 4 weeks of either thalidomide or placebo orally, administered once daily. Patients are followed weekly. Complete responders after 4 weeks of acute treatment enter a 24-week maintenance phase. A pharmacokinetic substudy will be included.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
EXCLUDED FOR MAINTENANCE PHASE:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Study Chair: | Jacobson JM |
Study ID Numbers: | ACTG 251 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000790 |
Health Authority: | United States: Federal Government |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Thalidomide Stomatitis, Aphthous |
Mouth Diseases Sexually Transmitted Diseases, Viral Thalidomide Esophageal disorder Stomatitis Ulcer Acquired Immunodeficiency Syndrome AIDS-Related Complex Stomatitis, Aphthous |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Stomatognathic Diseases Viremia Esophageal Diseases Retroviridae Infections Aphthous stomatitis |
Communicable Diseases Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Infection |
Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Lentivirus Infections Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |