Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002192
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Tolerance Safety and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia
Sponsor:
Anderson Clinical Research
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Tolerance Safety and Activity of Rifapentine Alone and in Combination Therapy in AIDS Patients With Mycobacterium Avium Complex Bacteremia
Status:
COMPLETED
Status Verified Date:
1997-08
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 determine the antimicrobial activity and tolerability of rifapentine alone and in combination therapy in patients with AIDS and disseminated Mycobacterium avium complex MAC bacteremia To determine the pharmacokinetics of rifapentine and its metabolite 25-desacetyl alone and in combination therapy To determine the pharmacokinetics of azithromycin and clarithromycin and its 14-OH metabolite in combination therapy
Detailed Description:
This open-label sequential study is conducted in two parts a monotherapy phase and a combination treatment phase
In the monotherapy phase sequential 3-patient cohorts receive 1 of 3 doses of rifapentine monotherapy
In the combination treatment phase 12 patients each are randomized to one of three arms
Arm I Rifapentine assigned dose level based on monotherapy phase plus azithromycin
Arm II Rifapentine assigned dose level plus clarithromycin Arm III Rifapentine assigned dose level plus ethambutol
In the monotherapy phase sequential 3-patient cohorts receive 1 of 3 doses of rifapentine monotherapy
In the combination treatment phase 12 patients each are randomized to one of three arms
Arm I Rifapentine assigned dose level based on monotherapy phase plus azithromycin
Arm II Rifapentine assigned dose level plus clarithromycin Arm III Rifapentine assigned dose level plus ethambutol
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 |
|---|---|---|---|
| 96ACR-HMD1 | None | None | None |
| 000473PR0018 | None | None | None |