Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067574
Status:
WITHDRAWN
Last Update Posted:
2017-03-06
First Post:
2003-08-25
Brief Title:
Treatment Plan to Decrease Drug Exposure in HIV Infected Adolescents
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Structured Treatment Interruption as an Autovaccination Approach to Enhance Immune Based HIV-1 Control in an AdolescentYoung Adult Population
Status:
WITHDRAWN
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was never opened for enrollment concept became irrelevant as other study results became available
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will attempt to stimulate the immune system in HIV infected adolescents and young adults so that it can better control the HIV infection When anti-HIV drugs are stopped for a period of time the virus grows back This may stimulate the immune system which may then be more effective in controlling the virus
Detailed Description:
The focus of this study is to use Structured Treatment Interruption STI as an approach to auto-immunization The STI management schema is based on current understanding of HIV-1 viral dynamics pharmacology of available antiretroviral medications and HIV-specific host responses This is a Phase II trial to provide preliminary data on the feasibility and possible efficacy of using STI to enhance immune-based control of HIV-1 replication A steady state HIV-1 viral load determined from historical tests prior to initiating highly active antiretroviral therapy HAART will be compared to the steady state viral load post-STI HIV-1 specific CD4 and CD8 cell responses will be measured before and after the period of STI management and HIV-1 specific CD8 cell maturational phenotype will be assessed and correlated with ability to control viral replication
Adolescents and young adults who have either had sustained viral suppression on HAART for at least 2 years or who have had sustained viral suppression from 3 to 6 months will be eligible for this study Participants will have 12 weeks of HAART followed by 2 to 4 weeks of treatment interruption Participants will undergo three rounds of this regimen After the third STI participants will have an additional 12 weeks of HAART and then stop therapy Participants will be monitored off HAART for up to 20 weeks During this time if there is evidence of HIV progression two consecutive viral loads exceeding 10000 copiesml two consecutive CD4 cell counts under 350 cellsmicroL two consecutive CD4 percentages less than 15 or two consecutive CD4 cell counts less than 50 of baseline standard continuous antiretroviral therapy will be reinstituted Plasma HIV RNA will be tested monthly during therapy and weekly while subjects are off treatment Immunologic studies are monthly throughout the study Participants will be involved in the study for approximately 2 years
Adolescents and young adults who have either had sustained viral suppression on HAART for at least 2 years or who have had sustained viral suppression from 3 to 6 months will be eligible for this study Participants will have 12 weeks of HAART followed by 2 to 4 weeks of treatment interruption Participants will undergo three rounds of this regimen After the third STI participants will have an additional 12 weeks of HAART and then stop therapy Participants will be monitored off HAART for up to 20 weeks During this time if there is evidence of HIV progression two consecutive viral loads exceeding 10000 copiesml two consecutive CD4 cell counts under 350 cellsmicroL two consecutive CD4 percentages less than 15 or two consecutive CD4 cell counts less than 50 of baseline standard continuous antiretroviral therapy will be reinstituted Plasma HIV RNA will be tested monthly during therapy and weekly while subjects are off treatment Immunologic studies are monthly throughout the study Participants will be involved in the study for approximately 2 years
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