Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000644
Status:
COMPLETED
Last Update Posted:
2011-02-25
First Post:
1999-11-02
Brief Title:
A Phase II Safety and Efficacy Study of Clarithromycin in the Treatment of Disseminated M Avium Complex MAC Infections in Patients With AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Safety and Efficacy Study of Clarithromycin in the Treatment of Disseminated M Avium Complex MAC Infections in Patients With AIDS
Status:
COMPLETED
Status Verified Date:
2011-02
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:
This study is designed to evaluate the efficacy and safety of clarithromycin given orally at 1 of 3 doses to treat disseminated Mycobacterium avium complex infections MAC in patients with AIDS
Mycobacterium avium complex MAC is thought to be the most common disseminated bacterial opportunistic infection in AIDS with clinical prevalence estimates ranging from 15 to 50 percent of all AIDS patients Clarithromycin a new macrolide antimicrobial agent has demonstrated activity against MAC both in the laboratory and in animals Clinical experience treating AIDS patients with clarithromycin for disseminated MAC is limited However early studies have indicated few adverse effects and some improvement in clinical symptoms scores and Karnofsky performance scores over placebo treated patients
Mycobacterium avium complex MAC is thought to be the most common disseminated bacterial opportunistic infection in AIDS with clinical prevalence estimates ranging from 15 to 50 percent of all AIDS patients Clarithromycin a new macrolide antimicrobial agent has demonstrated activity against MAC both in the laboratory and in animals Clinical experience treating AIDS patients with clarithromycin for disseminated MAC is limited However early studies have indicated few adverse effects and some improvement in clinical symptoms scores and Karnofsky performance scores over placebo treated patients
Detailed Description:
Mycobacterium avium complex MAC is thought to be the most common disseminated bacterial opportunistic infection in AIDS with clinical prevalence estimates ranging from 15 to 50 percent of all AIDS patients Clarithromycin a new macrolide antimicrobial agent has demonstrated activity against MAC both in the laboratory and in animals Clinical experience treating AIDS patients with clarithromycin for disseminated MAC is limited However early studies have indicated few adverse effects and some improvement in clinical symptoms scores and Karnofsky performance scores over placebo treated patients
Treatment is randomly assigned so that twice as many patients receive clarithromycin at the lower dose as at an intermediate dose for 12 weeks Once data becomes available to support dosing patients with clarithromycin at the highest dose then treatment will be randomly assigned so that twice as many patients receive clarithromycin at the highest dose as at the intermediate dose Sixteen patients per group 48 patients in all will be enrolled Patients exhibiting clinical improvement or clinical cure while on this trial will be allowed to continue on therapy for an additional 6 months Patients will have clinical evaluations including the Karnofsky Performance Scale laboratory evaluations hematology and chemistry and blood cultures for MAC performed monthly
Treatment is randomly assigned so that twice as many patients receive clarithromycin at the lower dose as at an intermediate dose for 12 weeks Once data becomes available to support dosing patients with clarithromycin at the highest dose then treatment will be randomly assigned so that twice as many patients receive clarithromycin at the highest dose as at the intermediate dose Sixteen patients per group 48 patients in all will be enrolled Patients exhibiting clinical improvement or clinical cure while on this trial will be allowed to continue on therapy for an additional 6 months Patients will have clinical evaluations including the Karnofsky Performance Scale laboratory evaluations hematology and chemistry and blood cultures for MAC performed monthly
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?: