Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000971
Status:
COMPLETED
Last Update Posted:
2008-08-04
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex MAC Infections in Children With AIDS
Sponsor:
Abbott
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Dose-Ranging Pharmacokinetic Drug Interaction Safety and Preliminary Efficacy Study of Oral Clarithromycin Granules for Suspension in Combination With Zidovudine or Dideoxyinosine in the Treatment of Disseminated Mycobacterium Avium Complex Infections in Pediatric Patients With AIDS
Status:
COMPLETED
Status Verified Date:
1996-10
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 evaluate three doses of clarithromycin in children with AIDS and Mycobacterium avium complex MAC infection who are receiving concurrent antiretroviral therapy
Before more extensive evaluation of this promising drug for treatment of MAC infection in children can be done it is important to study the pharmacokinetics of this drug in this population to get information regarding its use in pediatric patients receiving currently available antiretroviral drugs and to get information on the antimycobacterial activity of this drug
Before more extensive evaluation of this promising drug for treatment of MAC infection in children can be done it is important to study the pharmacokinetics of this drug in this population to get information regarding its use in pediatric patients receiving currently available antiretroviral drugs and to get information on the antimycobacterial activity of this drug
Detailed Description:
Before more extensive evaluation of this promising drug for treatment of MAC infection in children can be done it is important to study the pharmacokinetics of this drug in this population to get information regarding its use in pediatric patients receiving currently available antiretroviral drugs and to get information on the antimycobacterial activity of this drug
Patients that are included are HIV infected and have started zidovudine AZT or didanosine ddI at least 4 weeks before entry into this study Patients continue taking the medications at prescribed doses In addition they also take clarithromycin Patients continue treatment with AZT or ddI plus clarithromycin for 12 weeks
Patients that are included are HIV infected and have started zidovudine AZT or didanosine ddI at least 4 weeks before entry into this study Patients continue taking the medications at prescribed doses In addition they also take clarithromycin Patients continue treatment with AZT or ddI plus clarithromycin for 12 weeks
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 |
|---|---|---|---|
| NCI 91 C-53 | None | None | None |