Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002343
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Rifabutin Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex MAC Bacteremia in Patients With AIDS
Sponsor:
Pharmacia
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open-Label Randomized PharmacokineticPharmacodynamic Study of Mycobutin Rifabutin or Rifabutin in Combination With Myambutol Ethambutol for Prophylaxis of Mycobacterium Avium Complex MAC Bacteremia in AIDS Patients With CD4 Counts 100 Cellsmm3
Status:
COMPLETED
Status Verified Date:
1997-06
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 optimize Mycobacterium avium Complex MAC prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population
Detailed Description:
Patients are randomized to receive oral rifabutin alone or rifabutinethambutol daily for 12 months with possible continuation of medicine lifelong Doses will be adjusted to maintain minimum blood levels of the drugs
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 |
|---|---|---|---|
| CS 087287-000 | None | None | None |