Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000951
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase IV Randomized Study of the Use of Fluconazole as Chronic Suppressive Therapy Versus Episodic Therapy in HIV Positive Subjects With Recurrent Oropharyngeal Candidiasis
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:
The purpose of this study is to determine whether it is better to treat patients with fluconazole on a continuous basis to prevent thrush yeast infection in the mouth from coming back or to wait and treat each episode of thrush
Fluconazole is one of the most commonly prescribed drugs to treat thrush and other yeast infections However the number of patients with fluconazole-resistant thrush is increasing and it is not known whether continuous or intermittent use of fluconazole leads to greater resistance Therefore it is important to determine the most effective treatment strategy
Fluconazole is one of the most commonly prescribed drugs to treat thrush and other yeast infections However the number of patients with fluconazole-resistant thrush is increasing and it is not known whether continuous or intermittent use of fluconazole leads to greater resistance Therefore it is important to determine the most effective treatment strategy
Detailed Description:
This study will evaluate two different management strategies for patients with advanced HIV infection who are at risk for recurrent and fluconazole-refractory oropharyngeal candidiasis The treatment duration will be at least 24 months in order to evaluate the long-term effects of the treatment strategies on the development of fluconazole-refractory thrush In addition to investigating antifungal treatment as it relates to fluconazole-refractory infections the study will evaluate host factors and organism-related factors in order to increase our understanding of the pathogenesis of oropharyngeal candidiasis and fluconazole-refractory infections
Prior to randomization to a long-term management strategy using fluconazole patients are stratified into one of three groups according to their baseline CD4 count cellsmm3 0-49 50-100 and 101-150 Patients without oropharyngeal candidiasis no thrush present at enrollment and those patients who respond no thrush present to the initial acute therapy for an active infection are randomized 11 to one of two management strategies for fluconazole Arm A episodic therapy or Arm B chronic suppressive therapy with continuous fluconazole Patients are then followed for a duration of 24 months after enrollment of the last subject Patients with active oropharyngeal candidiasis at time of enrollment will be treated with fluconazole for up to 2 weeks and patients who respond no thrush present are then randomized to a long-term management strategy Those who do not respond refractory disease to the acute treatment are permanently discontinued from the study Women in both groups will have the option of being treated for vulvovaginal candidiasis either through or outside the study
Prior to randomization to a long-term management strategy using fluconazole patients are stratified into one of three groups according to their baseline CD4 count cellsmm3 0-49 50-100 and 101-150 Patients without oropharyngeal candidiasis no thrush present at enrollment and those patients who respond no thrush present to the initial acute therapy for an active infection are randomized 11 to one of two management strategies for fluconazole Arm A episodic therapy or Arm B chronic suppressive therapy with continuous fluconazole Patients are then followed for a duration of 24 months after enrollment of the last subject Patients with active oropharyngeal candidiasis at time of enrollment will be treated with fluconazole for up to 2 weeks and patients who respond no thrush present are then randomized to a long-term management strategy Those who do not respond refractory disease to the acute treatment are permanently discontinued from the study Women in both groups will have the option of being treated for vulvovaginal candidiasis either through or outside the study
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 |
|---|---|---|---|
| 11297 | REGISTRY | DAIDS ES Registry Number | None |