Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000895
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients With Advanced HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pathogenesis of MAC Disease in Advanced HIV-1-Infected Subjects and the Impact of Highly-Active Antiretroviral Treatment HAART on Immune Functions Relevant for MAC and Other Opportunistic Infections
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:
The purpose of this study is to determine if infection with Mycobacterium avium complex MAC occurs in other parts of the body before it is found in the blood This study also evaluates the relationships between the amount of HIV in the blood immune system functions and the presence of MAC infection
HIV-positive patients are at risk for MAC infection because their immune systems have been weakened by HIV It is hoped that aggressive treatment with anti-HIV drugs may improve their immune systems enough to prevent against MAC
HIV-positive patients are at risk for MAC infection because their immune systems have been weakened by HIV It is hoped that aggressive treatment with anti-HIV drugs may improve their immune systems enough to prevent against MAC
Detailed Description:
The intent of this study is to define more precisely the natural history and immunopathogenesis of MAC disease in the HIV-infected population It is suggested that MAC disease in AIDS patients results both from specific immunologic deficiencies caused by HIV infection of the host and as a result of specific mycobacterial virulence properties Therefore aggressive antiretroviral drug treatment of HIV-infected patients at risk for DMAC due to specific immune deficiencies will improve these immune functions in such a manner as to resist DMAC
A total of 85 patients will be stratified at baseline into one of three groups
Group I - 40 patients at high risk for MAC infection are neither followed beyond baseline nor receive study treatment
Group II - 15 patients with DMAC ie newly diagnosed MAC-bacteremic patients with no more than 72 hours prior treatment for MAC receive individualized regimen of HAART for 48 weeks nelfinavir NEV nevirapine NVP and nucleoside reverse transcriptase inhibitors as per primary physician Patients are evaluated through clinical microbiologic and virologic assessments and intensive immunologic evaluations at Weeks 12 24 and 48
Group III - 30 asymptomatic HIV-infected patients are further stratified 15 patientsstratum by CD4 count less than or equal to 50 cellsmm3 or 100-250 cellsmm3 Patients in Group III follow the same HAART regimen and evaluations as Group II patients and continue evaluations for up to 48 weeks if an acceptable response is found within 12 weeks of entry Patients in Stratum 1 of Group III receive MAC prophylaxis with azithromycin once weekly with follow-up evaluations as in Group II Patients in Group III that have a positive MAC blood or bone marrow culture at any time during the study will from that point on follow the same schedule of evaluations as patients in Group II
AS PER AMENDMENT 11398 Up to 100 evaluable patients will now be studied Group 2 is now modified to include up to an additional 15 evaluable patients with known MAC bacteremia and less than or equal to 7 days prior MAC treatment who are unable to commit to long-term follow-up Group 2b these patients will undergo only baseline evaluations Group 2a consists of 15 evaluable patients with known MAC bacteremia and less than or equal to 7 days of prior MAC treatment who are willing and able to enter the follow-up phase
A total of 85 patients will be stratified at baseline into one of three groups
Group I - 40 patients at high risk for MAC infection are neither followed beyond baseline nor receive study treatment
Group II - 15 patients with DMAC ie newly diagnosed MAC-bacteremic patients with no more than 72 hours prior treatment for MAC receive individualized regimen of HAART for 48 weeks nelfinavir NEV nevirapine NVP and nucleoside reverse transcriptase inhibitors as per primary physician Patients are evaluated through clinical microbiologic and virologic assessments and intensive immunologic evaluations at Weeks 12 24 and 48
Group III - 30 asymptomatic HIV-infected patients are further stratified 15 patientsstratum by CD4 count less than or equal to 50 cellsmm3 or 100-250 cellsmm3 Patients in Group III follow the same HAART regimen and evaluations as Group II patients and continue evaluations for up to 48 weeks if an acceptable response is found within 12 weeks of entry Patients in Stratum 1 of Group III receive MAC prophylaxis with azithromycin once weekly with follow-up evaluations as in Group II Patients in Group III that have a positive MAC blood or bone marrow culture at any time during the study will from that point on follow the same schedule of evaluations as patients in Group II
AS PER AMENDMENT 11398 Up to 100 evaluable patients will now be studied Group 2 is now modified to include up to an additional 15 evaluable patients with known MAC bacteremia and less than or equal to 7 days prior MAC treatment who are unable to commit to long-term follow-up Group 2b these patients will undergo only baseline evaluations Group 2a consists of 15 evaluable patients with known MAC bacteremia and less than or equal to 7 days of prior MAC treatment who are willing and able to enter the follow-up phase
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 |
|---|---|---|---|
| 11312 | REGISTRY | DAIDS ES | None |