Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001097
Status:
COMPLETED
Last Update Posted:
2010-04-26
First Post:
1999-11-02
Brief Title:
Long-Term Effects of HAART in Youth With Stronger Immune Systems Versus Youth With Weaker Immune Systems
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Establishment and Maintenance of Long-Term Undetectable Plasma HIV-1 RNA Correlation With Immunologic Reconstitution and Viral Dynamics
Status:
COMPLETED
Status Verified Date:
2005-11
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 see if children and young adults with better immune systems before starting highly active antiretroviral therapy HAART do better than those who have weaker immune systems before starting HAART
HIV infection weakens the immune systems ability to fight other infections and diseases HAART is a type of anti-HIV therapy shown to improve the immune system of adults However not all patients show the same amount of improvement with HAART Doctors believe that results may depend on how strong a patients immune system is before starting HAART Long-term effects of HAART in children and young adults have not yet been studied
HIV infection weakens the immune systems ability to fight other infections and diseases HAART is a type of anti-HIV therapy shown to improve the immune system of adults However not all patients show the same amount of improvement with HAART Doctors believe that results may depend on how strong a patients immune system is before starting HAART Long-term effects of HAART in children and young adults have not yet been studied
Detailed Description:
Recent adult clinical trials involving combination HAART including a protease inhibitor PI have demonstrated improvements in somatic immune system functioning AS PER AMENDMENT 22701 More recently similar success has been demonstrated with a PI-sparing regimen zidovudine lamivudine and efavirenz Not all individuals however experience the same level of immune reconstitution and oftentimes any improvement is short-lived Adolescent patients may have a greater potential for immune restoration because of residual thymic tissue and therefore may experience greater long-term virus-free states as compared to adult patients This study examines the duration of virologic efficacy HAART has on the adolescent HIV-positive population
Patients begin study by initiating a HAART regimen of a minimum of 3 drugs at least 1 of which must be a PI AS PER AMENDMENT 22701 or efavirenz EFV A variety of drug combinations are used therefore patients are grouped according to the classes of drugs in their respective regimen eg 2 nucleoside reverse transcriptase inhibitors NRTIs plus 1 PI 2 NRTIs plus 2 PIs 1 or 2 NRTIs plus 1 PI plus 1 nonnucleoside reverse transcriptase inhibitor NNRTI AS PER AMENDMENT 22701 and 2 NRTIs plus EFV At the time of HAART initiation patients undergo immunologic and virologic assessments in order to determine baseline values Then to determine the virologic success or failure of HAART HIV-1 RNA measurements are taken and compared to initial baseline values Virologic success equals undetectable HIV-1 RNA at Week 12 AS PER AMENDMENT 22701 and confirmed at Week 16 or a significant greater than 1 log decrease in HIV-1 RNA from baseline to Week 12 AS PER AMENDMENT 22701 and confirmed undetectable HIV-1 RNA before the next scheduled visit Week 24 Patients are followed for a minimum of 3 years of maintained viral suppression or until they have demonstrated virologic failure From these values any correlation that may exist between HIV-1 RNA values and HAART can be deduced Patients with virologic failure on the initial HAART regimen may be allowed to change to a second HAART regimen AS PER AMENDMENT 22701 Patients with virologic success on the second HAART regimen are followed for a minimum of 3 years Patients with virologic failure on the second HAART regimen or who voluntarily discontinue HAART are followed using an abbreviated schedule for 3 years
Patients begin study by initiating a HAART regimen of a minimum of 3 drugs at least 1 of which must be a PI AS PER AMENDMENT 22701 or efavirenz EFV A variety of drug combinations are used therefore patients are grouped according to the classes of drugs in their respective regimen eg 2 nucleoside reverse transcriptase inhibitors NRTIs plus 1 PI 2 NRTIs plus 2 PIs 1 or 2 NRTIs plus 1 PI plus 1 nonnucleoside reverse transcriptase inhibitor NNRTI AS PER AMENDMENT 22701 and 2 NRTIs plus EFV At the time of HAART initiation patients undergo immunologic and virologic assessments in order to determine baseline values Then to determine the virologic success or failure of HAART HIV-1 RNA measurements are taken and compared to initial baseline values Virologic success equals undetectable HIV-1 RNA at Week 12 AS PER AMENDMENT 22701 and confirmed at Week 16 or a significant greater than 1 log decrease in HIV-1 RNA from baseline to Week 12 AS PER AMENDMENT 22701 and confirmed undetectable HIV-1 RNA before the next scheduled visit Week 24 Patients are followed for a minimum of 3 years of maintained viral suppression or until they have demonstrated virologic failure From these values any correlation that may exist between HIV-1 RNA values and HAART can be deduced Patients with virologic failure on the initial HAART regimen may be allowed to change to a second HAART regimen AS PER AMENDMENT 22701 Patients with virologic success on the second HAART regimen are followed for a minimum of 3 years Patients with virologic failure on the second HAART regimen or who voluntarily discontinue HAART are followed using an abbreviated schedule for 3 years
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 |
|---|---|---|---|
| PACTG 381 | None | None | None |