Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050284
Status:
COMPLETED
Last Update Posted:
2010-11-09
First Post:
2002-12-03
Brief Title:
Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Predictors of Immunologic and Clinical Progression in Subjects With CD4 Cell Counts Greater Than 350 Cellsmm3 Who Discontinue Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2010-11
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 whether patients who have asymptomatic HIV infection can discontinue antiretroviral therapy ART without adverse clinical virologic or immunologic consequences This study will also assess the virologic immunologic and clinical outcomes in any patients who restart ART
Detailed Description:
Patients who can discontinue ART without a significant loss of virologic or immunologic control and without an increase in clinical events may be spared the expense and adverse effects of treatment However the consequences of treatment discontinuation in patients with asymptomatic HIV infections are not well understood This study will follow the clinical and immunologic progression of HIV infection in patients who have low HIV viral load and preserved CD4 cell counts at the time ART is stopped
Patients will fast for at least 8 hours prior to the first study visit At this visit blood will be drawn and body measurements will be taken Patients will then discontinue their ART Patients taking nonnucleoside reverse transcriptase inhibitors NNRTIs will stop taking NNRTIs 48 hours before withdrawing their other ART drugs Study visits will occur every 4 to 8 weeks for the first year then every 12 weeks for the second year Blood will be taken at most visits and patients will be asked to fast for at least 8 hours prior to Week 12 and 24 visits and again every 6 months Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 24 weeks
Patients will fast for at least 8 hours prior to the first study visit At this visit blood will be drawn and body measurements will be taken Patients will then discontinue their ART Patients taking nonnucleoside reverse transcriptase inhibitors NNRTIs will stop taking NNRTIs 48 hours before withdrawing their other ART drugs Study visits will occur every 4 to 8 weeks for the first year then every 12 weeks for the second year Blood will be taken at most visits and patients will be asked to fast for at least 8 hours prior to Week 12 and 24 visits and again every 6 months Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 24 weeks
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