Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000790
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection
Status:
COMPLETED
Status Verified Date:
2021-10
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:
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 062894 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 062894 amendment to evaluate the safety of thalidomide Per 051095 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
SECONDARY To evaluate the effect of thalidomide on blood tumor necrosis factor TNF levels and to obtain pharmacokinetic data on the drug Per 062894 amendment to evaluate the safety of thalidomide Per 051095 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
Detailed Description:
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
Patients are randomized to receive 4 weeks of either thalidomide or placebo orally administered once daily Patients are followed weekly Complete responders after 4 weeks of acute treatment enter a 24-week maintenance phase A pharmacokinetic substudy will be included
Patients are randomized to receive 4 weeks of either thalidomide or placebo orally administered once daily Patients are followed weekly Complete responders after 4 weeks of acute treatment enter a 24-week maintenance phase A pharmacokinetic substudy will be included
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11228 | REGISTRY | DAIDS ES Registry Number | None |