Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001542
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Fluconazole Prophylaxis of Thrush in AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Fluconazole Prophylaxis of Thrush in AIDS
Status:
COMPLETED
Status Verified Date:
2001-11
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 is a placebo-controlled trial of intermittent fluconazole prophylaxis 200 mg orally three times a week in the prevention of thrush
Detailed Description:
Oropharyngeal candidiasis OPC occurs in up to 93 of persons with human immunodeficiency virus HIV infection at some time during the course of their illness OPC usually responds well to initial antifungal therapy but with increasing immunodeficiency it usually recurs and can become resistant to clinical and microbiologic cure Therapy usually begins with topical agents followed by systemic therapy with azole antifungals when those fail Amphotericin B is also used but is less well tolerated and usually only effective in parenteral form Because of its bioavailability and efficacy fluconazole has become the most commonly used agent in treating OPC Recurrences have often led to frequent re-treatment or prophylactic therapy with fluconazole Daily prophylaxis with fluconazole 200 mg has been shown to decrease the incidence of OPC With the widespread and prolonged use of fluconazole reports of clinical failures and yeasts with decreased susceptibilities have appeared This resistance appears to be associated with advanced immunosuppression and azole exposure The most effective regimen to decrease relapse and morbidity from OPC which minimizes development of resistance has not been established Could less frequent andor lower dose prophylaxis with fluconazole decrease the incidence of recurrences while slowing the development of drug resistance
We plan to perform a two phase study of low-dose fluconazole prophylaxis in HIV infected patients with a history of OPC Patients with advanced immunosuppression CD4 less than or equal to 150 cellmm3 who have not received prior fluconazole prophylaxis will be included Phase 1 of the study will be a placebo-controlled trial of fluconazole at a dose of 200 mg three times weekly Phase 1 will examine whether this low-dose prophylaxis can delay recurrence of OPC Phase 2 of the study will be an open-label prophylaxis with fluconazole at first 200mg thrice weekly then 200mg daily as patients develop recurrent OPC In this phase the primary question to be answered will be whether subjects starting in the placebo arm of Phase 1 will progress more or less rapidly to clinical fluconazole failure compared to those starting in the fluconazole arm We will learn more about the natural history of fluconazole resistance including how gradually the change occurs how much fluconazole the patient has received at the time resistance develops and whether the resistance occurs in the patients own isolate or from acquisition of a new isolate Other evaluations will include compliance cost and host and organism-associated factors If thrice weekly fluconazole prophylaxis can increase the time to development of resistance and decrease episodes of OPC in this group of severely immunocompromised individuals it would increase the effective use to include cost-effective use of fluconazole in the treatment of OPC
We plan to perform a two phase study of low-dose fluconazole prophylaxis in HIV infected patients with a history of OPC Patients with advanced immunosuppression CD4 less than or equal to 150 cellmm3 who have not received prior fluconazole prophylaxis will be included Phase 1 of the study will be a placebo-controlled trial of fluconazole at a dose of 200 mg three times weekly Phase 1 will examine whether this low-dose prophylaxis can delay recurrence of OPC Phase 2 of the study will be an open-label prophylaxis with fluconazole at first 200mg thrice weekly then 200mg daily as patients develop recurrent OPC In this phase the primary question to be answered will be whether subjects starting in the placebo arm of Phase 1 will progress more or less rapidly to clinical fluconazole failure compared to those starting in the fluconazole arm We will learn more about the natural history of fluconazole resistance including how gradually the change occurs how much fluconazole the patient has received at the time resistance develops and whether the resistance occurs in the patients own isolate or from acquisition of a new isolate Other evaluations will include compliance cost and host and organism-associated factors If thrice weekly fluconazole prophylaxis can increase the time to development of resistance and decrease episodes of OPC in this group of severely immunocompromised individuals it would increase the effective use to include cost-effective use of fluconazole in the treatment of OPC
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-I-0108 | None | None | None |