Status:
COMPLETED
Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Andrulis Pharmaceuticals
Conditions:
HIV Infections
Stomatitis, Aphthous
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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 ulceratio...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 1998
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00000790
End Date
October 1 1998
Last Update
November 4 2021
Active Locations (40)
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1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
3
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
4
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115