Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016783
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
2001-06-02
Brief Title:
Stopping and Restarting Anti-HIV Drugs in Children and Adolescents With Low Blood Levels of HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Intensification of HIV-Specific CD4 and CD8 Activity by Cycling Highly Active Antiretroviral Therapy HAART in PediatricAdolescent Patients With Less Than 50 HIV RNA Copiesml
Status:
COMPLETED
Status Verified Date:
2013-10
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:
Some patients taking anti-HIV drugs as part of highly active antiretroviral therapy HAART do not show any HIV in the blood however some HIV will remain hidden in the body and if the drugs are stopped will return to the blood The purpose of this study is to determine if short periods of stopping HAART increase the activity of CD8 and CD4 cells cells of the immune system that fight infection if repeated stopping of these drugs for longer periods of time and restarting them will increase effectiveness of HAART and if the increased immune system activity as a result of stopping treatment leads to lower levels of HIV over time
Detailed Description:
Some HIV infected patients taking HAART have been able to achieve prolonged suppression of HIV viral load for extended periods of time However discontinuing HAART has consistently resulted in HIVs return to plasma Both CD8 and CD4 cells are markedly reduced in individuals with prolonged HIV suppression control of and response to cell-associated HIV is dependent on immune-mediated mechanisms involving these cells It is hypothesized that a brief and low-level increase in HIV levels resulting from HAART interruption might boost HIV-specific CD8 and CD4 T-cell counts After suppression of viral load with the reintroduction of HAART the expanded CD8 population might be able to better control viral replication and better respond to cell-associated HIV Future treatment interruption may lead to longer periods of undetectable viral loads
Patients are divided into 2 age cohorts with Cohort 1 consisting of children and adolescents 4 years and older up to 21 years of age and Cohort 2 consisting of children and adolescents 2 years and older up to 4 years of age Patients will be assigned to one of 2 groups Group A patients will participate in drug holiday cycles from HAART and then back to HAART Group B is a control group that remains on continuous HAART throughout the study Cycle 1 for Group A patients begins with 18 days of HAART and a 3-day drug holiday At the end of the drug holiday viral load is measured and HAART is resumed for 28 days detectable virus cycle if viral load is detectable after the drug holiday If viral load remains below the level of detection the patient begins the next drug holiday cycle With each subsequent drug holiday cycle time off HAART will increase by 2 days Patients failing 4 repeated detectable virus 28-day treatment cycles will be taken off study
Patients will be enrolled in this study for a minimum of 142 weeks For Group A HIV viral load and CD4 cell count are measured at the end of each drug holiday and each HAART resumption HIV-specific CD4 and CD8 responses are measured every 3 cycles and cell-associated HIV is assessed at entry at 12-week intervals and at the end of the study For Group B physical exams are conducted and HIV viral load and other blood work are measured every 12 weeks
Patients are divided into 2 age cohorts with Cohort 1 consisting of children and adolescents 4 years and older up to 21 years of age and Cohort 2 consisting of children and adolescents 2 years and older up to 4 years of age Patients will be assigned to one of 2 groups Group A patients will participate in drug holiday cycles from HAART and then back to HAART Group B is a control group that remains on continuous HAART throughout the study Cycle 1 for Group A patients begins with 18 days of HAART and a 3-day drug holiday At the end of the drug holiday viral load is measured and HAART is resumed for 28 days detectable virus cycle if viral load is detectable after the drug holiday If viral load remains below the level of detection the patient begins the next drug holiday cycle With each subsequent drug holiday cycle time off HAART will increase by 2 days Patients failing 4 repeated detectable virus 28-day treatment cycles will be taken off study
Patients will be enrolled in this study for a minimum of 142 weeks For Group A HIV viral load and CD4 cell count are measured at the end of each drug holiday and each HAART resumption HIV-specific CD4 and CD8 responses are measured every 3 cycles and cell-associated HIV is assessed at entry at 12-week intervals and at the end of the study For Group B physical exams are conducted and HIV viral load and other blood work are measured every 12 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11650 | REGISTRY | DAIDS ES | None |
| PACTG P1015 | None | None | None |
| ACTG P1015 | None | None | None |