Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000907
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
1999-11-02
Brief Title:
A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex DMAC 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 Study of Discontinuing Maintenance Therapy in Subjects With Disseminated Mycobacterium Avium Complex DMAC
Status:
COMPLETED
Status Verified Date:
2003-06
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 evaluate the effects of stopping preventive therapy for DMAC in HIV-positive patients who 1 have been treated for DMAC for at least 12 months and are now free of any signs of DMAC for at least 16 weeks and 2 have improved immune systems CD4 cell counts greater than or equal to 100 cellsmm3 due to anti-HIV drug therapy
DMAC is a serious and sometimes life-threatening infection that usually affects only HIV-positive patients with CD4 cell counts cells of the immune system that fight infection less than 50 cellsmm3 It is recommended that people who are likely to get DMAC be placed on preventive medications which help reduce the risk of infection New anti-HIV combination drug therapies can increase CD4 cell counts and can reduce the level of HIV in the blood When CD4 counts are increased risk of DMAC infection is less This study examines whether it is possible to stop preventive therapy for DMAC when CD4 counts are high without placing individuals at risk for getting DMAC again
DMAC is a serious and sometimes life-threatening infection that usually affects only HIV-positive patients with CD4 cell counts cells of the immune system that fight infection less than 50 cellsmm3 It is recommended that people who are likely to get DMAC be placed on preventive medications which help reduce the risk of infection New anti-HIV combination drug therapies can increase CD4 cell counts and can reduce the level of HIV in the blood When CD4 counts are increased risk of DMAC infection is less This study examines whether it is possible to stop preventive therapy for DMAC when CD4 counts are high without placing individuals at risk for getting DMAC again
Detailed Description:
A growing body of evidence suggests AIDS-related morbidity and mortality significantly decrease where potent antiretroviral therapies are used HAART highly active antiretroviral therapy seems to significantly reduce the incidence of MAC This study tests the validity of those observations
Peripheral blood cultures and bone marrow aspirate samples from 50 eligible patients previously diagnosed with disseminated Mycobacterium avium complex DMAC are assessed for microbiologic sterilization of MAC at the time of study entry If either bone marrow or blood cultures test positive for MAC patients are discontinued from study If cultures prove sterile patients receive 6 weeks of treatment and then discontinue MAC therapy at Week 6 entry into Step 2 of study They are then monitored for clinical signs and symptoms of MAC recurrence and for the presence of mycobacteria in blood cultures In cases of increased viral load during study modification of antiretroviral therapy is allowed at the discretion of the patients provider
Peripheral blood cultures and bone marrow aspirate samples from 50 eligible patients previously diagnosed with disseminated Mycobacterium avium complex DMAC are assessed for microbiologic sterilization of MAC at the time of study entry If either bone marrow or blood cultures test positive for MAC patients are discontinued from study If cultures prove sterile patients receive 6 weeks of treatment and then discontinue MAC therapy at Week 6 entry into Step 2 of study They are then monitored for clinical signs and symptoms of MAC recurrence and for the presence of mycobacteria in blood cultures In cases of increased viral load during study modification of antiretroviral therapy is allowed at the discretion of the patients provider
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 |
|---|---|---|---|
| AACTG 393 | None | None | None |