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NCT00000790

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

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Completion Date

1998-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections Stomatitis, Aphthous

Keywords

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Acquired Immunodeficiency Syndrome AIDS-Related Complex Thalidomide Stomatitis, Aphthous

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Thalidomide

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacobson JM

Role: STUDY_CHAIR

Locations

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Univ of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States

Site Status

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, United States

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Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, United States

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Harbor UCLA Med Ctr

Torrance, California, United States

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Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

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Howard Univ

Washington D.C., District of Columbia, United States

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Univ of Miami School of Medicine

Miami, Florida, United States

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Queens Med Ctr

Honolulu, Hawaii, United States

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Univ of Hawaii

Honolulu, Hawaii, United States

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Northwestern Univ Med School

Chicago, Illinois, United States

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Cook County Hosp

Chicago, Illinois, United States

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Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

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Louis A Weiss Memorial Hosp

Chicago, Illinois, United States

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Illinois Masonic Med Ctr

Chicago, Illinois, United States

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Indiana Univ Hosp

Indianapolis, Indiana, United States

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Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, United States

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Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States

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SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, United States

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Beth Israel Med Ctr

New York, New York, United States

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Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States

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Mount Sinai Med Ctr / Pediatrics

New York, New York, United States

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Mount Sinai Med Ctr

New York, New York, United States

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