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

Blood-Borne Infections+18

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

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

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.

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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsStomatognathic DiseasesMouth DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesStomatitisVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexStomatitis, AphthousHIV Infections

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

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps

Univ of Southern California / LA County USC Med Ctr

Los Angeles, United States

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, United States
Completed40 Study Centers