Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000883
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
1999-11-02
Brief Title:
Long-Term Assessment for Metabolic Cardiovascular and Neurologic Problems in HIV-Infected Patients With Increased CD4 Cells Counts Following Anti-HIV Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Long-Term Assessment for Metabolic Cardiovascular and Neurologic Complications In Subjects With Past CD4 Cellsmm3 Below 50 Who Increased CD4 Cellsmm3 to Above 100 on HAART
Status:
COMPLETED
Status Verified Date:
2012-10
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 see if there are any changes in sugar and fat levels in the blood when patients take anti-HIV therapy for many years Another goal is to test memory and mental concentrations to determine if anti-HIV drugs protect the brain from damage caused by HIV
The purpose of this study has been changed from the original version HIV-infected patients with low CD4 cell counts are at risk for getting opportunistic AIDS-related infections CD4 cells are cells of the immune system that help fight infection Anti-HIV therapy may increase CD4 counts which may lead to a decrease in AIDS-related infections Problems that anti-HIV therapy is associated with include metabolic problems neurologic problems abnormal opportunistic infections and cancer Patients in ACTG 362 have been exposed to anti-HIV therapy longer than any other large group in the ACTG These patients appear to benefit from their therapy but also suffer problems from it Observation of these patients should provide more information about long-term anti-HIV treatment and may detect unexpected problems
This study as been changed More information about the reasons for conducting this study has been added
The purpose of this study has been changed from the original version HIV-infected patients with low CD4 cell counts are at risk for getting opportunistic AIDS-related infections CD4 cells are cells of the immune system that help fight infection Anti-HIV therapy may increase CD4 counts which may lead to a decrease in AIDS-related infections Problems that anti-HIV therapy is associated with include metabolic problems neurologic problems abnormal opportunistic infections and cancer Patients in ACTG 362 have been exposed to anti-HIV therapy longer than any other large group in the ACTG These patients appear to benefit from their therapy but also suffer problems from it Observation of these patients should provide more information about long-term anti-HIV treatment and may detect unexpected problems
This study as been changed More information about the reasons for conducting this study has been added
Detailed Description:
The currently available data on clinical events in patients receiving potent antiretroviral therapy suggest that an alteration in the presentation of MAC disease may be seen and that rates of MAC disease may be reduced when patients respond to antiretroviral therapy However the extent of the protection and the timing of protection after initiation of therapy remain unknown The current study should provide validated measures of immune restoration and clinical data to guide prophylaxis decisions for the many patients who are now responding to therapy after years of immune depletion AS PER AMENDMENT 111699 The low rate of MAC in ACTG 362 patients after an average of 1 year of follow-up suggests that prophylaxis specifically for MAC disease with azithromycin is not necessary for patients who have experienced immune reconstitution Prolonged follow-up will define durability of the antiretroviral response and the experience with opportunistic conditions neurologic diseases and survival especially in those whose CD4 counts drop below 50 cellsmm3 It will also allow assessment of the levels of CD4 cell number at which vulnerability to opportunistic infection recur AS PER AMENDMENT 031803 During the extension of ACTG 362 serious complications of HAART have become better defined including metabolic complications neurologic problems atypical opportunistic infections and malignancies Patients in ACTG 362 have been exposed to HAART longer than any other large group in the ACTG and appear to benefit from and suffer complications of their therapy Continued observation should provide estimates of expected complications and durability of long-term potent antiretroviral treatment and may detect unanticipated problems
Patients are stratified at baseline for prior use of MAC into 3 groups no prophylaxis prior azithromycin prophylaxis and other MAC prophylaxis Patients are randomized to receive azithromycin Arm I or matching placebo Arm II once weekly and are followed every 8 weeks until study closure or for 18 months 72 weeks after the last patient is enrolled Patients who develop a drop in CD4 count below 50 cellsmm3 on 2 measurements at least 4 weeks apart are offered open-label azithromycin AS PER AMENDMENT 062498 Patients remain on open-label azithromycin regardless of subsequent CD4 counts AS PER AMENDMENT 111699 The phase of Version 10 or Version 20 in which patients receive blinded-study medication is now referred to as Step I The phase of Version 10 or Version 20 in which patients receive open-label azithromycin is now referred to as Step 2 Patients not currently on open-label azithromycin provided by the study enter Step 3 and discontinue study drugs but remain blinded to the original treatment and are followed at 16-week intervals until study closure which will occur in April 2002 3 years following enrollment of the last study participant Any patient who develops a drop in CD4 count below 50 cellsmm3 on 2 measurements at least 4 weeks apart is offered open-label azithromycin Patients currently receiving open-label azithromycin and patients from Step 3 who are initiating open-label azithromycin enter Step 4 Patients undergo regular clinical and laboratory evaluations that include physical examinations CD4 counts and viral load AS PER AMENDMENT 111699 Patients undergo clinical and laboratory evaluations every 16 weeks for 160 weeks that include physical examinations CD4 counts and viral load as well as neuropsychologic and cardiovascular assessments AS PER AMENDMENT 011801 All patients enrolled in the study are followed until April 2002 AS PER AMENDMENT 031802 All patients currently participating in ACTG 362 are invited to continue follow up for an additional 5 years Patients not currently receiving open-label azithromycin enter Step 5 Patients currently receiving open-label azithromycin enter Step 6 and continue to receive open-label treatment throughout the study Any patient who enters on Step 5 and develops a drop in CD4 below 50 cellsmm3 on 2 consecutive measurements at least 4 weeks apart is offered open-label azithromycin and enters Step 6 Patients are assessed for metabolic cardiovascular and neurologic complications and are evaluated for opportunistic infections CD4 counts and viral load Study visits occur at 32-week intervals until study closure
Patients are stratified at baseline for prior use of MAC into 3 groups no prophylaxis prior azithromycin prophylaxis and other MAC prophylaxis Patients are randomized to receive azithromycin Arm I or matching placebo Arm II once weekly and are followed every 8 weeks until study closure or for 18 months 72 weeks after the last patient is enrolled Patients who develop a drop in CD4 count below 50 cellsmm3 on 2 measurements at least 4 weeks apart are offered open-label azithromycin AS PER AMENDMENT 062498 Patients remain on open-label azithromycin regardless of subsequent CD4 counts AS PER AMENDMENT 111699 The phase of Version 10 or Version 20 in which patients receive blinded-study medication is now referred to as Step I The phase of Version 10 or Version 20 in which patients receive open-label azithromycin is now referred to as Step 2 Patients not currently on open-label azithromycin provided by the study enter Step 3 and discontinue study drugs but remain blinded to the original treatment and are followed at 16-week intervals until study closure which will occur in April 2002 3 years following enrollment of the last study participant Any patient who develops a drop in CD4 count below 50 cellsmm3 on 2 measurements at least 4 weeks apart is offered open-label azithromycin Patients currently receiving open-label azithromycin and patients from Step 3 who are initiating open-label azithromycin enter Step 4 Patients undergo regular clinical and laboratory evaluations that include physical examinations CD4 counts and viral load AS PER AMENDMENT 111699 Patients undergo clinical and laboratory evaluations every 16 weeks for 160 weeks that include physical examinations CD4 counts and viral load as well as neuropsychologic and cardiovascular assessments AS PER AMENDMENT 011801 All patients enrolled in the study are followed until April 2002 AS PER AMENDMENT 031802 All patients currently participating in ACTG 362 are invited to continue follow up for an additional 5 years Patients not currently receiving open-label azithromycin enter Step 5 Patients currently receiving open-label azithromycin enter Step 6 and continue to receive open-label treatment throughout the study Any patient who enters on Step 5 and develops a drop in CD4 below 50 cellsmm3 on 2 consecutive measurements at least 4 weeks apart is offered open-label azithromycin and enters Step 6 Patients are assessed for metabolic cardiovascular and neurologic complications and are evaluated for opportunistic infections CD4 counts and viral load Study visits occur at 32-week intervals until study closure
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?: