Thalidomide to Treat Oral Lesions in HIV-Infected Patients

NCT00001524 | Completed Phase 2

• 2 other identifiers: 96009596-D-0095
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the effectiveness of topical thalidomide in healing mouth sores in HIV infected patients. Oral (PO) thalidomide heals these sores at a dose of 200 mg per day. However, PO thalidomide can cause drowsiness, skin rashes, allergic reactions, increased viral load, and even nerve damage that may not be reversible. This study will evaluate the efficacy of a topical formulation of thalidomide (placed directly on the surface of the sore) for the healing of these sores. Persons with HIV infection of acquired immunodeficiency of at least 18 years of age with one or more chronic, painful intraoral lesions may be eligible for this study. Subjects must be referred by a primary care physician who is managing their care, and must have HIV/AIDS status confirmed. Patients' HIV treatment regimen will not be altered and those receiving highly active therapy will not be excluded. Patients will be excluded if they are concurrently being treated for mucosal lesions (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals, or mouthwashes), or concurrent thalidomide therapy; receving chemotherapy or radiation therapy for neoplasms; using concurrent acute therapy for opportunistic infections; concurrent use of sedatives (such as CNS depressants or alcohol use); history of allergy to thalidomide; pre-existing peripheral neuropathy of grade II or higher; pregnant or lactating females or those not practicing contraception according to FDA guidelines for thalidomide.

Conditions

Acquired Immunodeficiency Syndrome; Burning Mouth Syndrome; HIV Infection

Keywords

Thalidomide; Clinical Trial; Tumor Necrosis Factor; Delayed Healing; Painful Oral Lesions; HIV/AIDS; Mouth Ulcers; Aphthous Ulcers; Healing; Cytokines

Interventions

Thalidomide DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with HIV infection or acquired immunodeficiency of at least 18 years of age with one or more chronic, painful intraoral lesions will constitute the study sample for both studies.
• Subjects must be referred by a primary care physician who is managing their care, and must have HIV/AIDS status confirmed and current CD4 status provided by the primary physician.
• Patients' HIV treatment regimen will not be altered and those receiving highly active antiretroviral therapy will not be excluded.

You may not qualify if:

• Patients will be excluded from participation if taking any concurrent treatment for mucosal lesions (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals, or mouthwashes), prior to concurrent thalidomide therapy, chemotherapy or radiation therapy for neoplasms, concurrent acute therapy for opportunistic infection, concurrent use of sedatives (such as CNS depressants or alcohol use), history of allergy to thalidomide, pre-existing peripheral neuropathy of grade II or higher, and females of childbearing potential.
• Pregnant or lactating females will be excluded.
• Patients must be between ages 40 to 60 years.
• Cannot be using prescription or non-prescription medications except birth control.
• Cannot have acute or chronic current infections or illness.
• Cannot have autoimmune conditions, such as diabetes, lupus, or HIV (must be healthy).
• Cannot use within 24 hours: anti-inflammatory drugs or other analgesics.
• Cannot use within 24 hours: anti-histamines or allergy medications.
• Cannot use within 3 weeks: antidepressants or steroids.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Gardner-Medwin JM, Smith NJ, Powell RJ. Clinical experience with thalidomide in the management of severe oral and genital ulceration in conditions such as Behcet's disease: use of neurophysiological studies to detect thalidomide neuropathy. Ann Rheum Dis. 1994 Dec;53(12):828-32. doi: 10.1136/ard.53.12.828.

  PMID: 7864692 BACKGROUND

• Ghigliotti G, Repetto T, Farris A, Roy MT, De Marchi R. Thalidomide: treatment of choice for aphthous ulcers in patients seropositive for human immunodeficiency virus. J Am Acad Dermatol. 1993 Feb;28(2 Pt 1):271-2. doi: 10.1016/s0190-9622(08)81153-x. No abstract available.

  PMID: 8432932 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

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Burning Mouth Syndrome; HIV Infections; Oral Ulcer; Stomatitis, Aphthous

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; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mouth Diseases; Stomatognathic Diseases; Stomatitis

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 Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: June 1, 1996
• Study Completion: December 1, 2004
• Last Updated: March 4, 2008

Record last verified: 2004-12

Locations

US (1)