Completed

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

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What is being tested

Thalidomide

Drug
Who is being recruted

HIV Infections

+ Stomatitis, Aphthous
Over 13 Years
How is the trial designed

Treatment Study

Phase 2
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleThalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
164 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Stomatitis, Aphthous
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 40 locations
Suspended
Univ of Alabama at BirminghamBirmingham, United StatesSee the location
Suspended
Univ of Southern California / LA County USC Med CtrLos Angeles, United States
Suspended
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, United States
Suspended
Stanford at Kaiser / Kaiser Permanente Med CtrSan Francisco, United States

Completed40 Study Centers