Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000627
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome
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:
To evaluate the use of fluconazole as 1 induction therapy in histoplasmosis 2 maintenance therapy to prevent relapse of histoplasmosis
Histoplasmosis is a serious opportunistic infection in patients with AIDS Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals but has not been completely evaluated in patients for this use It has been approved by the Food and Drug Administration for certain other fungal infections Nevertheless physicians are prescribing it to their patients with histoplasmosis This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients
Histoplasmosis is a serious opportunistic infection in patients with AIDS Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals but has not been completely evaluated in patients for this use It has been approved by the Food and Drug Administration for certain other fungal infections Nevertheless physicians are prescribing it to their patients with histoplasmosis This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients
Detailed Description:
Histoplasmosis is a serious opportunistic infection in patients with AIDS Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals but has not been completely evaluated in patients for this use It has been approved by the Food and Drug Administration for certain other fungal infections Nevertheless physicians are prescribing it to their patients with histoplasmosis This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients
At least 40 patients with AIDS and an initial episode of disseminated histoplasmosis are selected for the study Patients receive fluconazole for a total of 12 weeks Patients who are unable to take the drug orally may receive it intravenously until oral administration is possible Patients are evaluated at weeks 0 1 2 4 8 and 12 Patients who are doing well without evidence of clinical failure or dose-limiting toxicity are permitted to continue maintenance therapy to prevent relapse at a reduced dose for an additional 12 months those who relapse on the reduced dose are permitted to receive re-induction with a higher dose
At least 40 patients with AIDS and an initial episode of disseminated histoplasmosis are selected for the study Patients receive fluconazole for a total of 12 weeks Patients who are unable to take the drug orally may receive it intravenously until oral administration is possible Patients are evaluated at weeks 0 1 2 4 8 and 12 Patients who are doing well without evidence of clinical failure or dose-limiting toxicity are permitted to continue maintenance therapy to prevent relapse at a reduced dose for an additional 12 months those who relapse on the reduced dose are permitted to receive re-induction with a higher dose
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 |
|---|---|---|---|
| 11149 | REGISTRY | DAIDS ES Registry Number | None |
| R-0245 | None | None | None |