Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000676
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex A Nested Study of ACTG 081
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex A Nested Study of ACTG 081
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 study the effectiveness safety and tolerance of fluconazole versus clotrimazole troches lozenges as prophylaxis preventive treatment against fungal infections in patients enrolled in ACTG 081 a study of prophylaxis against pneumocystosis toxoplasmosis and serious bacterial infection Primarily to compare the rates of invasive infections by C neoformans endemic mycoses and Candida To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments Secondarily to assess the effect of prophylaxis on the incidence of severe fungal infections defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection
Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection Oropharyngeal candidiasis is found in almost all such patients and causes pain difficulty in swallowing and loss of appetite Similarly esophageal candidiasis causes illness in the population Cryptococcosis endemic mycoses and coccidioidomycosis also cause significant illness and death in AIDS patients Once established fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection Animal studies have shown it to be prophylactic in models of candidiasis cryptococcosis histoplasmosis and coccidioidomycosis Initial experience in patients with active cryptococcal meningitis appears favorable and studies of oropharyngeal candidiasis show it to be effective
Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection Oropharyngeal candidiasis is found in almost all such patients and causes pain difficulty in swallowing and loss of appetite Similarly esophageal candidiasis causes illness in the population Cryptococcosis endemic mycoses and coccidioidomycosis also cause significant illness and death in AIDS patients Once established fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection Animal studies have shown it to be prophylactic in models of candidiasis cryptococcosis histoplasmosis and coccidioidomycosis Initial experience in patients with active cryptococcal meningitis appears favorable and studies of oropharyngeal candidiasis show it to be effective
Detailed Description:
Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection Oropharyngeal candidiasis is found in almost all such patients and causes pain difficulty in swallowing and loss of appetite Similarly esophageal candidiasis causes illness in the population Cryptococcosis endemic mycoses and coccidioidomycosis also cause significant illness and death in AIDS patients Once established fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection Animal studies have shown it to be prophylactic in models of candidiasis cryptococcosis histoplasmosis and coccidioidomycosis Initial experience in patients with active cryptococcal meningitis appears favorable and studies of oropharyngeal candidiasis show it to be effective
AMENDED 110190 Sufficient numbers of patients will be enrolled from all centers starting at week 8 of participation in the parent study to achieve a total of 240 evaluable patients who will remain in the nested study for a maximum duration of 45 months Enrollment will continue until all eligible and interested 081 patients are enrolled Fungal prophylaxis will begin at the time of enrollment into the nested study and will continue until an efficacy or safety end point is reached until withdrawal from the nested study or until death
Original design Patients included are those already enrolled in ACTG 081 Patients are enrolled from all centers at either week 8 12 16 20 24 28 or 32 of participation in the parent study They are randomized to receive either oral fluconazole or clotrimazole troches Prophylaxis continues until a serious fungal infection develops the end of the parent study is reached which is expected to be December 1991 the patient withdraws from either the nested or parent study or the patient dies Clinical examination is performed at 2 weeks and then monthly or more if clinically indicated for the duration of antifungal prophylaxis the schedule of evaluation is the same as for the parent study There is a 1-month postprophylaxis follow-up after discontinuation of prophylaxis for any reason
AMENDED 110190 Sufficient numbers of patients will be enrolled from all centers starting at week 8 of participation in the parent study to achieve a total of 240 evaluable patients who will remain in the nested study for a maximum duration of 45 months Enrollment will continue until all eligible and interested 081 patients are enrolled Fungal prophylaxis will begin at the time of enrollment into the nested study and will continue until an efficacy or safety end point is reached until withdrawal from the nested study or until death
Original design Patients included are those already enrolled in ACTG 081 Patients are enrolled from all centers at either week 8 12 16 20 24 28 or 32 of participation in the parent study They are randomized to receive either oral fluconazole or clotrimazole troches Prophylaxis continues until a serious fungal infection develops the end of the parent study is reached which is expected to be December 1991 the patient withdraws from either the nested or parent study or the patient dies Clinical examination is performed at 2 weeks and then monthly or more if clinically indicated for the duration of antifungal prophylaxis the schedule of evaluation is the same as for the parent study There is a 1-month postprophylaxis follow-up after discontinuation of prophylaxis for any reason
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 |
|---|---|---|---|
| 11504 | REGISTRY | DAIDS ES Registry Number | None |