Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001030
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex MAC or Disseminated MAC Disease 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:
A Prospective Randomized Comparative Study of the Safety and Efficacy of Clarithromycin Versus Rifabutin Versus the Combination of Clarithromycin Plus Rifabutin for the Prevention of Mycobacterium Avium Complex MAC Bacteremia or Disseminated MAC Disease in HIV-Infected Patients With CD4 Lymphocyte Counts 100 Cellsmm3
Status:
COMPLETED
Status Verified Date:
2021-10
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 compare the efficacy and safety of clarithromycin alone versus rifabutin alone versus the two drugs in combination for the prevention or delay of Mycobacterium avium Complex MAC bacteremia or disseminated MAC disease To compare other parameters such as survival toxicity and quality of life among the three treatment arms To obtain information on the incidence and clinical grade of targeted gynecologic conditions
Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment
Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment
Detailed Description:
Persons with advanced stages of HIV are considered to be at particular risk for developing disseminated MAC disease The development of an effective regimen for the prevention of disseminated MAC disease may be of substantial benefit in altering the morbidity and possibly the mortality associated with this disease and its treatment
Patients are randomized to receive clarithromycin alone rifabutin alone or the two drugs in combination daily Patients are evaluated every 4 weeks for the first 8 weeks and every 8 weeks thereafter for the duration of the study Patients are followed for 24 months Per amendment a pharmacokinetic substudy will be conducted
Patients are randomized to receive clarithromycin alone rifabutin alone or the two drugs in combination daily Patients are evaluated every 4 weeks for the first 8 weeks and every 8 weeks thereafter for the duration of the study Patients are followed for 24 months Per amendment a pharmacokinetic substudy will be conducted
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 |
|---|---|---|---|
| 11172 | REGISTRY | DAIDS ES Registry Number | None |
| CPCRA 009 | None | None | None |