Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006152
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-08-07
Brief Title:
A Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment
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 Restrictively Randomized Open-Label Pilot Study of Treatment Intensification of Early Virologic Failure
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The purpose of this study is to see if adding 1 or 2 drugs to the anti-HIV therapy of patients whose HIV levels increased while taking their anti-HIV drugs can lower viral load amount of HIV in the blood and keep it low up to Week 24 This study has been changed Previously only patients whose levels increased on their first round of anti-HIV drugs were being studied Anti-HIV drug treatments that contain a combination of 3 or more drugs can lower HIV levels raise CD4 cell counts and improve survival Unfortunately many patients fail their anti-HIV drug treatment when their HIV levels go above 500 copiesml Usually the next step is to switch the patient to different anti-HIV drugs Doctors would like to see whether adding 1 or 2 different drugs to the failed treatment also can lower HIV levels Adding 1 or 2 drugs might be better than switching all of the drugs since patients who take many different drugs can develop drug-resistant HIV This study has been changed Previously only patients taking protease inhibitors PI whose levels increased on their first round of anti-HIV drugs were being studied
Detailed Description:
Successful therapy following viral rebound has been problematic Intensification of the existing regimen by adding 1 or 2 drugs generally has been avoided However successfully adding new drugs to an existing regimen would be advantageous since it would expose the patient to fewer antiretroviral agents in the overall treatment course Recent evidence suggests that a significant proportion of patients who experience viral rebound while receiving a protease inhibitor PI actually have viral rebound with a PI-sensitive virus Other studies have shown that treatment decisions based on resistance assays result in better virologic outcomes This trial examines further the effect of resistance assay-directed intensification of a PI-containing antiretroviral regimen on viral load AS PER AMENDMENT 040301 The antiretroviral regimen need not contain a protease inhibitor
Patients are stratified by baseline plasma HIV-1 RNA levels 5000 copiesml or less versus greater than 5000 copiesml Patients undergo phenotypic drug resistance testing prior to study entry Based on the phenotypic results patients are AS PER AMENDMENT 11900 selectively randomized equally to 1 of 3 AS PER AMENDMENT 11900 1 of 2 intensification strategies while remaining on their current initial AS PER AMENDMENT 11900 background antiretroviral therapy ART AS PER AMENDMENT 040301 ART need not be initial A patient is excluded from randomization to an arm if that arm contains a drug to which the patient has phenotypic resistance Arm A adds abacavir ABC Arm B adds amprenavir APV AS PER AMENDMENT 11900 and ritonavir RTV Arm C adds didanosine ddI plus hydroxyurea HU AS PER AMENDMENT 11900 Arm C has been discontinued A patients HIV must be sensitive to at least 3 drugs AS PER AMENDMENT 11900 Each patient must be taking at least 3 drugs to which hisher HIV isolate is sensitive including ABC or APV and at least 2 other drugs that are part of the current initial background ART If phenotypic resistance testing at screening indicates resistance to a nucleoside reverse transcriptase inhibitor NRTI drug in the patients current initial background ART then the local investigator may choose to discontinue that drug However the patient and local investigator may choose to continue the drug but it will not be considered an active drug per this protocol AS PER AMENDMENT 040301 ART need not be initial Patients have regular clinic visits for physical exams and blood tests including CD4 and CD8 cell counts plasma HIV-1 RNA assays and tests for pharmacokinetic variability In the event of viral rebound of 500 copiesml or more at Week 12 or later phenotypicgenotypic drug resistance is assayed In addition phenotypic drug resistance is assayed at the primary endpoint Week 24 and at the end of treatment Week 48 on all patients
Patients are stratified by baseline plasma HIV-1 RNA levels 5000 copiesml or less versus greater than 5000 copiesml Patients undergo phenotypic drug resistance testing prior to study entry Based on the phenotypic results patients are AS PER AMENDMENT 11900 selectively randomized equally to 1 of 3 AS PER AMENDMENT 11900 1 of 2 intensification strategies while remaining on their current initial AS PER AMENDMENT 11900 background antiretroviral therapy ART AS PER AMENDMENT 040301 ART need not be initial A patient is excluded from randomization to an arm if that arm contains a drug to which the patient has phenotypic resistance Arm A adds abacavir ABC Arm B adds amprenavir APV AS PER AMENDMENT 11900 and ritonavir RTV Arm C adds didanosine ddI plus hydroxyurea HU AS PER AMENDMENT 11900 Arm C has been discontinued A patients HIV must be sensitive to at least 3 drugs AS PER AMENDMENT 11900 Each patient must be taking at least 3 drugs to which hisher HIV isolate is sensitive including ABC or APV and at least 2 other drugs that are part of the current initial background ART If phenotypic resistance testing at screening indicates resistance to a nucleoside reverse transcriptase inhibitor NRTI drug in the patients current initial background ART then the local investigator may choose to discontinue that drug However the patient and local investigator may choose to continue the drug but it will not be considered an active drug per this protocol AS PER AMENDMENT 040301 ART need not be initial Patients have regular clinic visits for physical exams and blood tests including CD4 and CD8 cell counts plasma HIV-1 RNA assays and tests for pharmacokinetic variability In the event of viral rebound of 500 copiesml or more at Week 12 or later phenotypicgenotypic drug resistance is assayed In addition phenotypic drug resistance is assayed at the primary endpoint Week 24 and at the end of treatment Week 48 on all patients
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 |
|---|---|---|---|
| AACTG A5061 | Registry Identifier | DAIDS ES | None |
| 10898 | REGISTRY | None | None |
| ACTG A5061 | None | None | None |