Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001524
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Thalidomide to Treat Oral Lesions in HIV-Infected Patients
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of a TNF-Alpha Modulator for the Treatment of Oral Lesions in HIVAIDS Patients
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 HIVAIDS 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
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 HIVAIDS 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 96-D-0095 | None | None | None |