Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002122
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex MAC and Fungal Infections in HIV-Infected Patients
Sponsor:
Pfizer
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex MAC and Fungal Infections in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
1996-04
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:
PRIMARY To determine the efficacy of azithromycin and rifabutin alone and in combination for the prevention of disseminated Mycobacterium avium Complex MAC infection in HIV-infected patients To determine the efficacy of daily versus weekly fluconazole for the prevention of deep fungal infections in this patient population
SECONDARY To determine the incidence of bacterial including mycobacterial infections cryptosporidiosis and toxoplasmosis in azithromycin versus non-azithromycin containing regimens To determine the incidence of oropharyngeal and vaginal candidiasis in patients treated with daily versus weekly fluconazole To compare survival and outcomes of primary endpoints in the treatment arms
SECONDARY To determine the incidence of bacterial including mycobacterial infections cryptosporidiosis and toxoplasmosis in azithromycin versus non-azithromycin containing regimens To determine the incidence of oropharyngeal and vaginal candidiasis in patients treated with daily versus weekly fluconazole To compare survival and outcomes of primary endpoints in the treatment arms
Detailed Description:
Patients are randomized to receive azithromycin alone rifabutin alone or the two drugs in combination for MAC prophylaxis Patients in each treatment group further receive one of two doses of concomitant fluconazole for deep fungal prophylaxis unless specifically excluded for fluconazole randomization Patients are followed for 1 to 2 years
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 |
|---|---|---|---|
| 066-174 | None | None | None |