Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000975
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis a Fungal Infection in Patients With AIDS
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 Itraconazole for Primary Treatment and Suppression of Relapse of Disseminated 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 feasibility of itraconazole as 1 primary therapy in histoplasmosis and 2 maintenance therapy after completion of primary therapy To evaluate the effect of therapy of CNS histoplasmosis To determine if resistance to drug occurs in patients who fail therapy
Histoplasmosis is a serious opportunistic infection in patients with AIDS Although the clinical response to amphotericin B treatment in the AIDS patients is generally good administration difficulties and toxicity detract from its usefulness Oral treatment with ketoconazole overcomes these limitations of amphotericin B but does not appear to be effective for primary treatment in patients with AIDS Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis The frequency of adverse reactions to itraconazole has been low in several studies Central nervous system CNS involvement occurs in up to 20 percent of patients with histoplasmosis and appears to have a poor response to amphotericin B treatment Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis supporting a study of its use in CNS histoplasmosis
Histoplasmosis is a serious opportunistic infection in patients with AIDS Although the clinical response to amphotericin B treatment in the AIDS patients is generally good administration difficulties and toxicity detract from its usefulness Oral treatment with ketoconazole overcomes these limitations of amphotericin B but does not appear to be effective for primary treatment in patients with AIDS Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis The frequency of adverse reactions to itraconazole has been low in several studies Central nervous system CNS involvement occurs in up to 20 percent of patients with histoplasmosis and appears to have a poor response to amphotericin B treatment Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis supporting a study of its use in CNS histoplasmosis
Detailed Description:
Histoplasmosis is a serious opportunistic infection in patients with AIDS Although the clinical response to amphotericin B treatment in the AIDS patients is generally good administration difficulties and toxicity detract from its usefulness Oral treatment with ketoconazole overcomes these limitations of amphotericin B but does not appear to be effective for primary treatment in patients with AIDS Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis The frequency of adverse reactions to itraconazole has been low in several studies Central nervous system CNS involvement occurs in up to 20 percent of patients with histoplasmosis and appears to have a poor response to amphotericin B treatment Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis supporting a study of its use in CNS histoplasmosis
At least 30 patients with AIDS and an initial episode of disseminated histoplasmosis are selected for this study Up to 5 patients will have a diagnosis of CNS histoplasmosis Therapy with all other systemic antifungal agents must be halted before study entry Patients receive itraconazole for 3 days followed by daily oral doses for a total of 12 weeks Patients who are doing well clinically 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 Patients who are being treated for CNS histoplasmosis will continue to receive itraconazole
At least 30 patients with AIDS and an initial episode of disseminated histoplasmosis are selected for this study Up to 5 patients will have a diagnosis of CNS histoplasmosis Therapy with all other systemic antifungal agents must be halted before study entry Patients receive itraconazole for 3 days followed by daily oral doses for a total of 12 weeks Patients who are doing well clinically 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 Patients who are being treated for CNS histoplasmosis will continue to receive itraconazole
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 |
|---|---|---|---|
| 11095 | REGISTRY | DAIDS ES Registry Number | None |