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

NCT00000790 | Completed Phase 2

• 2 other identifiers: ACTG 25111228
• Study Type: interventional
• Target: 164
• Locations: 2 countries
• Sites: 40

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 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.

Conditions

HIV Infections; Stomatitis, Aphthous

Keywords

Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Thalidomide; Stomatitis, Aphthous

Interventions

Thalidomide DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Andrulis Pharmaceuticals: collaborator

Study Sites (40)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, 94115, United States

Location

Harbor UCLA Med Ctr

Torrance, California, 90502, United States

Location

Univ of Colorado Health Sciences Ctr

Denver, Colorado, 80262, United States

Location

Howard Univ

Washington D.C., District of Columbia, 20059, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

Queens Med Ctr

Honolulu, Hawaii, 96816, United States

Location

Univ of Hawaii

Honolulu, Hawaii, 96816, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Louis A Weiss Memorial Hosp

Chicago, Illinois, 60640, United States

Location

Illinois Masonic Med Ctr

Chicago, Illinois, 606575147, United States

Location

Indiana Univ Hosp

Indianapolis, Indiana, 462025250, United States

Location

Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess - West Campus

Boston, Massachusetts, 02215, United States

Location

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, 14215, United States

Location

Beth Israel Med Ctr

New York, New York, 10003, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Mount Sinai Med Ctr / Pediatrics

New York, New York, 10029, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

SUNY / State Univ of New York

Syracuse, New York, 13210, United States

Location

Bronx Municipal Hosp Ctr/Jacobi Med Ctr

The Bronx, New York, 10461, United States

Location

Comprehensive Health Care Ctr / Bronx Municipal Hosp

The Bronx, New York, 10461, United States

Location

Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp

The Bronx, New York, 10461, United States

Location

Montefiore Drug Treatment Ctr / Bronx Municipal Hosp

The Bronx, New York, 10461, United States

Location

Montefiore Family Health Ctr / Bronx Municipal Hosp

The Bronx, New York, 10461, United States

Location

Jack Weiler Hosp / Bronx Municipal Hosp

The Bronx, New York, 10465, United States

Location

Montefiore Med Ctr / Bronx Municipal Hosp

The Bronx, New York, 10467, United States

Location

North Central Bronx Hosp / Bronx Municipal Hosp

The Bronx, New York, 10467, United States

Location

Bronx Veterans Administration / Mount Sinai Hosp

The Bronx, New York, 10468, United States

Location

Univ of North Carolina

Chapel Hill, North Carolina, 275997215, United States

Location

Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

Milton S Hershey Med Ctr

Hershey, Pennsylvania, 170330850, United States

Location

Thomas Jefferson Univ Hosp

Philadelphia, Pennsylvania, 191075098, United States

Location

Meharry Med College

Nashville, Tennessee, 37203, United States

Location

Univ of Washington

Seattle, Washington, 981224304, United States

Location

Univ of Puerto Rico

San Juan, 009365067, Puerto Rico

Location

Related Publications (5)

• Jacobson JM, Spritzler J, Fox L, Fahey JL, Jackson JB, Chernoff M, Wohl DA, Wu AW, Hooton TM, Sha BE, Shikuma CM, MacPhail LA, Simpson DM, Trapnell CB, Basgoz N. Thalidomide for the treatment of esophageal aphthous ulcers in patients with human immunodeficiency virus infection. National Institute of Allergy and Infectious Disease AIDS Clinical Trials Group. J Infect Dis. 1999 Jul;180(1):61-7. doi: 10.1086/314834.

  PMID: 10353862 BACKGROUND

• Jacobson JM, Greenspan JS, Spritzler J, Ketter N, Fahey JL, Jackson JB, Fox L, Chernoff M, Wu AW, MacPhail LA, Vasquez GJ, Wohl DA. Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group. N Engl J Med. 1997 May 22;336(21):1487-93. doi: 10.1056/NEJM199705223362103.

  PMID: 9154767 BACKGROUND

• Gilden D. Thalidomide and aphthous ulcers. GMHC Treat Issues. 1995 Nov;9(11):12.

  PMID: 11362988 BACKGROUND

• Jacobson JM, Greenspan JS, Spritzler J, Fox L, Fahey JL, Jackson JB, Chernoff M, Wohl DA, Pulvirenti JJ, Hooton TM, Shikuma C. Thalidomide in low intermittent doses does not prevent recurrence of human immunodeficiency virus-associated aphthous ulcers. J Infect Dis. 2001 Jan 15;183(2):343-346. doi: 10.1086/317928. Epub 2000 Dec 15.

  PMID: 11120935 BACKGROUND

• Aweeka F, Trapnell C, Chernoff M, Jayewardene A, Spritzler J, Bellibas SE, Lizak P, Jacobson J. Pharmacokinetics and pharmacodynamics of thalidomide in HIV patients treated for oral aphthous ulcers: ACTG protocol 251. AIDS Clinical Trials Group. J Clin Pharmacol. 2001 Oct;41(10):1091-7. doi: 10.1177/00912700122012698.

  PMID: 11583477 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Stomatitis, Aphthous; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Stomatitis; Mouth Diseases; Stomatognathic Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jacobson JM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: October 1, 1998
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

PR (1); US (39)