Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000744
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Randomized Prospective Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Prospective Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
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 compare the efficacy of fluconazole versus placebo for the prevention of Candida esophagitis and vaginaloropharyngeal candidiasis including a comparison of the development of clinical resistance
Fluconazole has been shown to be effective in preventing or suppressing candidiasis in HIV-negative women An increasing likelihood of oral and esophageal candidiasis in conjunction with progressive immunosuppression raises the question of the potential role of prophylactic antifungal therapy in high-risk persons
Fluconazole has been shown to be effective in preventing or suppressing candidiasis in HIV-negative women An increasing likelihood of oral and esophageal candidiasis in conjunction with progressive immunosuppression raises the question of the potential role of prophylactic antifungal therapy in high-risk persons
Detailed Description:
Fluconazole has been shown to be effective in preventing or suppressing candidiasis in HIV-negative women An increasing likelihood of oral and esophageal candidiasis in conjunction with progressive immunosuppression raises the question of the potential role of prophylactic antifungal therapy in high-risk persons
Four hundred HIV-infected women are randomized to receive fluconazole or placebo weekly for up to 2 years Patients undergo follow-up every 3 months or more often if signs and symptoms of mucosal candidiasis occur
Four hundred HIV-infected women are randomized to receive fluconazole or placebo weekly for up to 2 years Patients undergo follow-up every 3 months or more often if signs and symptoms of mucosal candidiasis occur
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 |
|---|---|---|---|
| 11562 | REGISTRY | DAIDS ES Registry Number | None |