Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006316
Status:
COMPLETED
Last Update Posted:
2008-08-01
First Post:
2000-09-28
Brief Title:
Withdrawal of Antifungal Treatment for Histoplasmosis in Patients After Improved Immune Response to Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Discontinuation of Antifungal Therapy for Histoplasmosis Following Immunologic Response to Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2004-02
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:
The purpose of this study is to determine whether stopping preventive histoplasmosis medications in patients who are currently receiving effective anti-HIV drugs will place them at risk for getting histoplasmosis again
Histoplasmosis is a serious opportunistic AIDS-related infection that responds well to antifungal medications Before anti-HIV drugs patients with histoplasmosis required lifelong antifungal therapy Patients who take anti-HIV drugs for a long time may see an improvement in their immune system functions Improved immune function may eliminate the need for long-term preventive treatment with antifungal agents Doctors want to see if the improved immune functions allow preventive treatment for histoplasmosis to be stopped This study has been changed to include histoplasmosis treatment with drugs other than itraconazole
Histoplasmosis is a serious opportunistic AIDS-related infection that responds well to antifungal medications Before anti-HIV drugs patients with histoplasmosis required lifelong antifungal therapy Patients who take anti-HIV drugs for a long time may see an improvement in their immune system functions Improved immune function may eliminate the need for long-term preventive treatment with antifungal agents Doctors want to see if the improved immune functions allow preventive treatment for histoplasmosis to be stopped This study has been changed to include histoplasmosis treatment with drugs other than itraconazole
Detailed Description:
Histoplasmosis is a serious opportunistic infection in persons with AIDS that demonstrates an excellent response to antifungal therapy However until the advent of highly active antiretroviral therapy HAART patients with histoplasmosis required lifelong suppressive antifungal therapy It is thought that immune reconstitution as a result of HAART may diminish the need for chronic therapy Histoplasmosis offers an opportunity to examine the concept of discontinuation of maintenance therapy as it is rapidly diagnosed and effectively treated with itraconazole AS PER AMENDMENT 92700 or other appropriate therapy for disseminated histoplasmosis should relapse occur
Patients discontinue antifungal maintenance therapy Patients are seen for routine visits every 8 weeks and urine and serum specimens are collected for real time Histoplasma antigen testing and immunologic parameters Patients with suspected recurrence as determined by clinical or routine laboratory findings consistent with recurrent histoplasmosis are reevaluated within 1 week of onset of these findings Patients with suspected recurrence based on a serum or urine Histoplasma antigen rise of 2 units or more in the absence of clinical or routine laboratory findings consistent with histoplasmosis are reevaluated within 2 weeks All patients with suspected recurrence have more frequent evaluations and additional laboratory tests Those with negative studies resume bimonthly follow-up All patients who develop proven positive culture or positive fungal stain of tissues or body fluids or probable relapse clinical findings of relapse with an increase in antigen of 41 units or more or no clinical findings but increases in antigen levels on repeated testing with the most recent antigen test demonstrating an increase in antigen of 41 units or more or who experience persistent reduction of CD4 cell count to below 100mm3 have antifungal induction therapy reinstituted Patients remain on study for at least 12 months with regular follow-upevaluations
Patients discontinue antifungal maintenance therapy Patients are seen for routine visits every 8 weeks and urine and serum specimens are collected for real time Histoplasma antigen testing and immunologic parameters Patients with suspected recurrence as determined by clinical or routine laboratory findings consistent with recurrent histoplasmosis are reevaluated within 1 week of onset of these findings Patients with suspected recurrence based on a serum or urine Histoplasma antigen rise of 2 units or more in the absence of clinical or routine laboratory findings consistent with histoplasmosis are reevaluated within 2 weeks All patients with suspected recurrence have more frequent evaluations and additional laboratory tests Those with negative studies resume bimonthly follow-up All patients who develop proven positive culture or positive fungal stain of tissues or body fluids or probable relapse clinical findings of relapse with an increase in antigen of 41 units or more or no clinical findings but increases in antigen levels on repeated testing with the most recent antigen test demonstrating an increase in antigen of 41 units or more or who experience persistent reduction of CD4 cell count to below 100mm3 have antifungal induction therapy reinstituted Patients remain on study for at least 12 months with regular follow-upevaluations
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 |
|---|---|---|---|
| AACTG A5038 | None | None | None |