Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With… (NCT00000790) | Clinical Trial Compass
CompletedPhase 2
Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection
United States, Puerto Rico164 participants
Plain-language 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 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.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* Radiati…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00000790
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)