Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001023
Status:
COMPLETED
Last Update Posted:
2012-10-31
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Rifabutin Combined With Clarithromycin or Azithromycin in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of the Safety Tolerance and Pharmacokinetics of RifabutinClarithromycin Combination and RifabutinAzithromycin Combination in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2012-10
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:
PER 031094 AMENDMENT PART B To determine whether there is an effect on plasma drug levels of azithromycin and rifabutin as measured by changes in the plasma concentration-time curve AUC when these drugs are taken concomitantly
ORIGINAL PRIMARY To gain preliminary information about the safety and tolerance of clarithromycin and azithromycin in combination with rifabutin three potential agents against Mycobacterium avium-intracellulare in HIV-infected patients with CD4 counts 200 cellsmm3
ORIGINAL SECONDARY To determine whether there is an effect on the pharmacokinetics of the macrolide antibiotics or rifabutin when these drugs are taken concomitantly To monitor the effect of rifabutin therapy on dapsone serum levels in patients taking dapsone for PCP prophylaxis To monitor the effect of macroliderifabutin combination therapies on AZT or ddI serum levels
Two new macrolide antibiotics clarithromycin and azithromycin and rifabutin a rifamycin derivative have all demonstrated in vitro and in vivo activity against Mycobacterium avium-intracellulare a common systemic bacterial infection complicating AIDS Further information is needed however regarding the clinical and pharmacokinetic interaction of these drugs used in combination
ORIGINAL PRIMARY To gain preliminary information about the safety and tolerance of clarithromycin and azithromycin in combination with rifabutin three potential agents against Mycobacterium avium-intracellulare in HIV-infected patients with CD4 counts 200 cellsmm3
ORIGINAL SECONDARY To determine whether there is an effect on the pharmacokinetics of the macrolide antibiotics or rifabutin when these drugs are taken concomitantly To monitor the effect of rifabutin therapy on dapsone serum levels in patients taking dapsone for PCP prophylaxis To monitor the effect of macroliderifabutin combination therapies on AZT or ddI serum levels
Two new macrolide antibiotics clarithromycin and azithromycin and rifabutin a rifamycin derivative have all demonstrated in vitro and in vivo activity against Mycobacterium avium-intracellulare a common systemic bacterial infection complicating AIDS Further information is needed however regarding the clinical and pharmacokinetic interaction of these drugs used in combination
Detailed Description:
Two new macrolide antibiotics clarithromycin and azithromycin and rifabutin a rifamycin derivative have all demonstrated in vitro and in vivo activity against Mycobacterium avium-intracellulare a common systemic bacterial infection complicating AIDS Further information is needed however regarding the clinical and pharmacokinetic interaction of these drugs used in combination
AMENDED 031094 Part B Approximately 38 HIV-infected or uninfected subjects are randomized to receive azithromycin or rifabutin Groups 3 and 4 daily for 14 days followed by a combination regimen of both drugs for 4 additional weeks Patients are followed weekly Pharmacokinetic sampling will be performed on days 14 15 and 42-45
ORIGINAL Sixty-eight patients are randomly assigned to one of four groups 17 patients per group They receive either clarithromycin or azithromycin in combination with rifabutin on one of two different dosing schedules Patients receive medication for 6 weeks and undergo follow-up weekly during drug administration and at week 8
AMENDED 031094 Part B Approximately 38 HIV-infected or uninfected subjects are randomized to receive azithromycin or rifabutin Groups 3 and 4 daily for 14 days followed by a combination regimen of both drugs for 4 additional weeks Patients are followed weekly Pharmacokinetic sampling will be performed on days 14 15 and 42-45
ORIGINAL Sixty-eight patients are randomly assigned to one of four groups 17 patients per group They receive either clarithromycin or azithromycin in combination with rifabutin on one of two different dosing schedules Patients receive medication for 6 weeks and undergo follow-up weekly during drug administration and at week 8
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 |
|---|---|---|---|
| 11732 | REGISTRY | DAIDS ES Registry Number | None |