Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036465
Status:
COMPLETED
Last Update Posted:
2013-07-29
First Post:
2002-05-10
Brief Title:
Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Controlled Pilot Study of Antiretroviral Switch at Lower Versus Higher HIV-1 RNA Levels in Subjects Experiencing Virologic Relapse on a Current HAART Regimen
Status:
COMPLETED
Status Verified Date:
2013-07
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:
This study will look at people who have been taking anti-HIV drugs but still have detectable levels of HIV The purpose of the study is to find out what happens in those people who change anti-HIV drugs when their viral load reaches 200 copies compared to those who change anti-HIV drugs when their viral load reaches 10000 copies This study will also look at drug resistance how well HIV responds to drugs viral fitness how well drug-resistant HIV copies itself and immunologic reconstitution how well the immune system recognizes various infections including HIV
Many patients experience virologic relapse increase in viral load after sustained viral load suppression within 1 to 2 years of taking anti-HIV drugs The approach to treatment for patients who experience virologic relapse while on a highly active antiretroviral therapy HAART has not been defined Current guidelines recommend switching to a new treatment regimen as soon as possible to prevent HIV from becoming even more resistant to anti-HIV drugs However there is evidence that patients can benefit from staying on the same HAART drugs even after virologic relapse This study wants to find what happens when drugs are changed immediately after virologic relapse when the viral load is lower compared to what happens if drugs are changed only after a delay when the viral load is higher
Many patients experience virologic relapse increase in viral load after sustained viral load suppression within 1 to 2 years of taking anti-HIV drugs The approach to treatment for patients who experience virologic relapse while on a highly active antiretroviral therapy HAART has not been defined Current guidelines recommend switching to a new treatment regimen as soon as possible to prevent HIV from becoming even more resistant to anti-HIV drugs However there is evidence that patients can benefit from staying on the same HAART drugs even after virologic relapse This study wants to find what happens when drugs are changed immediately after virologic relapse when the viral load is lower compared to what happens if drugs are changed only after a delay when the viral load is higher
Detailed Description:
Virologic relapse occurs within 1 to 2 years of antiretroviral therapy in up to 50 percent of HIV-infected individuals The best treatment approach for patients who experience virologic rebound while on highly active antiretroviral therapy HAART has not been defined Current guidelines recommend switching to a new treatment regimen shortly after virologic rebound in an effort to avoid sequential accumulation of multiple resistance mutations However early treatment switching has numerous disadvantages risk of virologic rebound on the new therapy a limited number of drug combinations available to treat such rebounds and difficulty in obtaining early genotypic and phenotypic drug-resistance information to guide treatment modification Delaying a switch to a new antiretroviral regimen has the advantage of preserving future treatment options and HIV levels may remain partially suppressed even after drug-resistant mutants emerge Moreover several observational studies describe maintenance of immunologic and clinical benefits of HAART even after virologic rebound Delayed treatment switches however raise concerns about sequential accumulation of drug resistance mutations that may diminish the chances of viral resuppression with successive HAART regimens and the long-term immune consequences of virologic rebound on HAART are not known It is therefore important to evaluate the viral and immunologic responses among patients randomized to either an early or delayed HAART switch
This study enrolls patients who have a viral load of at least 200 but less than 10000 copiesml The patients are randomized into 2 treatment arms Arm A immediate switch patients have genotypic resistance testing at entry Based on the resistance test results their antiretroviral treatment regimen is modified to a switch treatment regimen Switch treatment initiates no later than Week 4 Arm B delayed switch patients continue their current antiretroviral regimen and have genotypic resistance testing when their plasma HIV-1 RNA levels reach 10000 copiesml or greater Based on the resistance test results their antiretroviral treatment regimen is modified to a switch treatment regimen Switch treatment initiates no later than 4 weeks from the date of at least 10000 copiesml viral load or from the date of an absolute CD4 count reduced by 20 percent from baseline value Patients who never meet the switch criteria remain on study
All patients are followed for a minimum of 48 weeks after entry No antiretroviral drugs are provided by the study
This study enrolls patients who have a viral load of at least 200 but less than 10000 copiesml The patients are randomized into 2 treatment arms Arm A immediate switch patients have genotypic resistance testing at entry Based on the resistance test results their antiretroviral treatment regimen is modified to a switch treatment regimen Switch treatment initiates no later than Week 4 Arm B delayed switch patients continue their current antiretroviral regimen and have genotypic resistance testing when their plasma HIV-1 RNA levels reach 10000 copiesml or greater Based on the resistance test results their antiretroviral treatment regimen is modified to a switch treatment regimen Switch treatment initiates no later than 4 weeks from the date of at least 10000 copiesml viral load or from the date of an absolute CD4 count reduced by 20 percent from baseline value Patients who never meet the switch criteria remain on study
All patients are followed for a minimum of 48 weeks after entry No antiretroviral drugs are provided by the study
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 |
|---|---|---|---|
| 10933 | REGISTRY | DAIDS-ES | None |
| AACTG A5115 | None | None | None |
| ACTG A5115 | None | None | None |