Protocol Number: 96-D-0095

Title:

Evaluation of a TNF-alpha Modulator for the Treatment of Oral Lesions in HIV/AIDS Patients

Number:

96-D-0095

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.

Sponsoring Institute:

National Institute of Dental And Craniofacial Research (NIDCR)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA FOR PATIENTS:

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.

EXCLUSION CRITERIA FOR PATIENTS:

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.

INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

Patients must be between ages 40 to 60 years.

EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

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.

Special Instructions:

This study is not currently recruiting patients. The pilot study has concluded at this time. A multicenter clinical trial will be started in 2004 at sites throughout the country to further test this promising formulation.

Keywords:

Thalidomide

Clinical Trial

Tumor Necrosis Factor

Delayed Healing

Painful Oral Lesions

HIV/AIDS

Mouth Ulcers

Aphthous Ulcers

Healing

Cytokines

Recruitment Keywords:

None

Conditions:

Acquired Immunodeficiency Syndrome

Burning Mouth Syndrome

HIV Infection

Investigational Drug(s):

Thalidomide

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

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

Thalidomide: treatment of choice for aphthous ulcers in patients seropositive for human immunodeficiency virus

Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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Bethesda, Maryland 20892. Last update: 10/26/2004