Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000947
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Trial of Prophylaxis for Disseminated Mycobacterium Avium Complex Disease and Bacterial Pneumonia Versus Deferred Prophylaxis in HIV-Infected Patients Who Experience Rebound in CD4 Cell Count Due to Active Antiretroviral Therapy
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:
This study is designed to find out whether HIV-positive patients whose immune systems have improved after receiving anti-HIV treatment should take azithromycin to prevent Mycobacterium avium complex MAC disease This study also examines the possibility of putting off MAC prevention treatment in patients who respond well to anti-HIV drug therapy
Azithromycin is approved for the prevention of MAC disease in people with HIV and low CD4 cell counts However some people who have taken azithromycin have been found to carry antibiotic-resistant bacteria germs that can grow despite the presence of drugs used to kill them It is not known whether the risks associated with taking azithromycin outweigh the risk of getting MAC disease
Azithromycin is approved for the prevention of MAC disease in people with HIV and low CD4 cell counts However some people who have taken azithromycin have been found to carry antibiotic-resistant bacteria germs that can grow despite the presence of drugs used to kill them It is not known whether the risks associated with taking azithromycin outweigh the risk of getting MAC disease
Detailed Description:
The need for MAC prophylaxis in advanced HIV disease is recognized Prophylactic therapy is complicated however due to drug toxicity potential drug interactions patient noncompliance with multiagent regimens microbial drug resistance and high treatment costs This study assesses the feasibility of deferring MAC prophylaxis in patients whose CD4 cell counts rebound in response to antiretroviral therapy
In this double-blind placebo-controlled trial patients are randomized to receive azithromycin weekly or matching placebo Patients are switched to open-label azithromycin if they have an average CD4 cell count less than 50 cellsmm3 on 2 consecutive counts obtained at least 48 hours apart preferably no more than 60 days
AS PER AMENDMENT 102397 SUBSTUDY CPCRA 054 A subset of participants of CPCRA 048 have oropharyngeal swabs taken at baseline and 4 months after randomization Antibiotic susceptibility tests are then performed on isolates of S pneumoniae AS PER AMENDMENT 9399 Participants in protocol version 30 are followed for data collection purposes every 4 months for 18 months until January 31 2001 Data collection includes CD4 cell counts viral RNA measurements macrolide susceptibility in MAC isolates and antibiotic susceptibility of isolates from bacterial pneumonia episodes
In this double-blind placebo-controlled trial patients are randomized to receive azithromycin weekly or matching placebo Patients are switched to open-label azithromycin if they have an average CD4 cell count less than 50 cellsmm3 on 2 consecutive counts obtained at least 48 hours apart preferably no more than 60 days
AS PER AMENDMENT 102397 SUBSTUDY CPCRA 054 A subset of participants of CPCRA 048 have oropharyngeal swabs taken at baseline and 4 months after randomization Antibiotic susceptibility tests are then performed on isolates of S pneumoniae AS PER AMENDMENT 9399 Participants in protocol version 30 are followed for data collection purposes every 4 months for 18 months until January 31 2001 Data collection includes CD4 cell counts viral RNA measurements macrolide susceptibility in MAC isolates and antibiotic susceptibility of isolates from bacterial pneumonia episodes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11600 | REGISTRY | DAIDS ES | None |