|
Thalidomide to Treat Oral Lesions in HIV-Infected Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Thalidomide to Treat Oral Lesions in HIV-Infected Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Thalidomide to Treat Oral Lesions in HIV-Infected Patients Clinical research trials and Thalidomide to Treat Oral Lesions in HIV-Infected Patients medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Thalidomide to Treat Oral Lesions in HIV-Infected Patients. Thalidomide to Treat Oral Lesions in HIV-Infected Patients Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Thalidomide to Treat Oral Lesions in HIV-Infected Patients clinical trial. Participants frequently obtain the most expert healthcare available for their Thalidomide to Treat Oral Lesions in HIV-Infected Patients condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Thalidomide to Treat Oral Lesions in HIV-Infected Patients  Thalidomide to Treat Oral Lesions in HIV-Infected Patients
Thalidomide to Treat Oral Lesions in HIV-Infected Patients
For Condition: Acquired Immunodeficiency Syndrome,Burning Mouth Syndrome,HIV Infection
Status: Recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: This study will test the effectiveness of thalidomide in healing mouth sores in HIV-infected patients. These sores are thought to be caused partly by changes in the amount of a substance made by the body called tumor necrosis factor-alpha (TNF-alpha). Thalidomide can modify TNF-alpha levels. However, thalidomide can cause drowsiness, skin rashes, allergic reactions and even nerve damage that may not be reversible. This study will see if these side effects can be reduced by giving the drug topically (directly on the surface of the sore). Patients with HIV infection who are at least 18 years old and have one or more chronic painful lesions inside the mouth may be eligible for this study. The lesions must be present for at least 2 weeks and unresponsive to standard therapy. Because thalidomide can cause severe birth defects, women should not participate in this study unless they have been surgically sterilized-either by hysterectomy or tubal ligation. Male patients should wear condoms when having sex with women, and continue to do so for one month after the last dose. Female patients will be tested for pregnancy before beginning the study, every 2 weeks during the study and 1 month after the study ends. Participants will receive one of three possible treatments in a combination of paste and capsules: 1) thalidomide paste and inactive capsule; 2) inactive paste and thalidomide capsule; or 3) inactive paste and inactive capsule (placebo). The paste will be held in place by a mouthpiece constructed using a mold made from an imprint of the patient's mouth. The mouthpiece will be worn day and night, except while eating, until the sore heals or up to 8 weeks. Patients' sores will be evaluated in three ways: - Pictures will be taken of the sores using a special camera to measure their size. Earlier pictures will be compared with later ones to evaluate healing. - A piece of absorbent paper will be applied to the sores to soak up fluid that can be examined for chemicals such as TNF-alpha. - A small section of the sore will be biopsied (surgically removed for microscopic examination) to look for viruses, fungi, or chemicals that are sometimes seen in these types of sores. During the study, a physician will monitor participants' health status and medications. Patients' health history will be reviewed at the first visit and a brief physical examination will be performed at the beginning and end of the study. Blood and urine samples will be collected at the beginning of the study, every 2 weeks during the study, and at the end of the study. Blood samples will also be collected at three different visits to check blood levels of thalidomide. To check for drug side effects, patients will complete questionnaires and have nerve testing on the arm and foot at the beginning and end of the study.
Details: The proposed clinical trial will evaluate the efficacy of topically-applied thalidomide as a treatment for painful oral lesions in HIV-infected patients. Limited data suggest that this drug may be effective when given systemically, but is accompanied by a high incidence of side effects. Administration of the drug topically onto the lesion should result in high local concentrations within the lesion thereby suppressing tumor necrosis factor which is thought to be related to the size and severity of the lesion. Subjects will be randomly allocated to one of three possible groups: systemic administration of thalidomide, topical administration of thalidomide, and placebo. The dose of thalidomide will be determined in a dose escalation pilot study prior to the main study. Healing, pain, and the incidence of side effects will be assessed at baseline and weekly for up to eight weeks. Successful demonstration of an enhanced therapeutic effect or reduced toxicity may provide a basis for the development of novel routes of administration and drugs for the treatment of painful oral lesions associated with HIV infection and other diseases.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 110
Location and Contact Information:
National Institute of Dental And Craniofacial Research (NIDCR) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 960095; 96-D-0095
Study Start Date: June 8, 1996
Record last reviewed: April 29, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001524
Other Hiv Infection Studies:
1. Evaluation and Treatment of Oral Soft Tissue Diseases
2. Thalidomide to Treat Oral Lesions in HIV-Infected Patients
Related Studies:
Other HIV Infection Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Thalidomide to Treat Oral Lesions in HIV-Infected Patients
|
|
|
|
|
|
|
|
