Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001094
Status:
WITHDRAWN
Last Update Posted:
2015-03-09
First Post:
1999-11-02
Brief Title:
A Comparison of Nelfinavir Plus Saquinavir Plus Delavirdine or 3TCZDV Versus Nelfinavir Plus 3TCZDV in HIV-Infected Patients
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 Open-Label Trial of Combination Therapy With Nelfinavir NFV and Saquinavir SQVSgc With Delavirdine DLV or 3TCZDV Versus Nelfinavir NFV and 3TCZDV in Subjects With HIV Infection and 5000 HIV RNA CopiesML
Status:
WITHDRAWN
Status Verified Date:
2015-03
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:
To compare the long-term virologic response to combination therapy with two protease inhibitors ie nelfinavir NFV saquinavir soft gel capsule SQVsgc and delavirdine DLV or combination lamivudinezidovudine 3TCZDV Combivir versus NFV and 3TCZDV in the proportion of patients demonstrating virologic success 500 copiesml HIV RNA at week 48 without prior virologic or clinical failure To evaluate the safety and tolerance of combination protease inhibitors
To evaluate the durability of virologic response as assessed by the Roche Ultra Sensitive assay 200 copiesml and culturable virus To compare time to a confirmed virologic response two consecutive plasma HIV RNA levels 500 copiesml or to a confirmed treatment relapse following a confirmed virologic response across the treatment arms To evaluate biologic phenotype non-syncytium inducing versus syncytium inducing capacity and the evolution and patterns of viral resistance among patients with confirmed treatment failures at or after weeks 16 to 24 To compare immunologic benefits as measured by longitudinal CD4CD8 cell count profiles To evaluate the influence of baseline virologic and immunologic parameters on the magnitude and duration of plasma HIV RNA response To compare virologic response between the two dose schedules of NFV and SQVsgc bid vs tid and between NFV and SQVsgc with either DLV or combination 3TCZDV To evaluate compliance and exploratory population pharmacometrics
Past studies have shown that combination therapies not only will result in better clinical outcomes but may prolong the effects of therapy The enhanced effects seen with combination therapies are likely related to a greater suppression of HIV replication and alterations in resistance patterns Both in vitro and in vivo studies suggest that triple-drug therapy may have an advantage over one- and two-drug regimens Therefore triple-drug therapy appears to be an important strategy in the treatment of HIV infection
To evaluate the durability of virologic response as assessed by the Roche Ultra Sensitive assay 200 copiesml and culturable virus To compare time to a confirmed virologic response two consecutive plasma HIV RNA levels 500 copiesml or to a confirmed treatment relapse following a confirmed virologic response across the treatment arms To evaluate biologic phenotype non-syncytium inducing versus syncytium inducing capacity and the evolution and patterns of viral resistance among patients with confirmed treatment failures at or after weeks 16 to 24 To compare immunologic benefits as measured by longitudinal CD4CD8 cell count profiles To evaluate the influence of baseline virologic and immunologic parameters on the magnitude and duration of plasma HIV RNA response To compare virologic response between the two dose schedules of NFV and SQVsgc bid vs tid and between NFV and SQVsgc with either DLV or combination 3TCZDV To evaluate compliance and exploratory population pharmacometrics
Past studies have shown that combination therapies not only will result in better clinical outcomes but may prolong the effects of therapy The enhanced effects seen with combination therapies are likely related to a greater suppression of HIV replication and alterations in resistance patterns Both in vitro and in vivo studies suggest that triple-drug therapy may have an advantage over one- and two-drug regimens Therefore triple-drug therapy appears to be an important strategy in the treatment of HIV infection
Detailed Description:
Past studies have shown that combination therapies not only will result in better clinical outcomes but may prolong the effects of therapy The enhanced effects seen with combination therapies are likely related to a greater suppression of HIV replication and alterations in resistance patterns Both in vitro and in vivo studies suggest that triple-drug therapy may have an advantage over one- and two-drug regimens Therefore triple-drug therapy appears to be an important strategy in the treatment of HIV infection
This is a Phase II randomized controlled open-label trial of NFV SQVsgc and either DLV or combined 3TCZDV versus NFV and combined 3TCZDV Prior to randomization patients are stratified by HIV RNA above or below 65000 copiesml and by prior antiretroviral therapy no therapy vs any therapy Patients 100 patientsarm are then randomly assigned to one of four arms Arm I receives NFV plus combination 3TCZDV Arm II receives NFV plus SQVsgc plus combination 3TCZDV Arm III receives NFV plus SQVsgc plus DLV Arm IV receives NFV plus SQVsgc plus DLV Treatment continues for 48 weeks following enrollment of the last patient Response to treatment is assessed at week 16 Patients with confirmed plasma HIV RNA levels 500 copiesml at week 16 whose plasma HIV RNA has decreased since study entry day 0 may continue therapy and be reassessed at weeks 20 and 24 Patients considered treatment failures ie 2 consecutive plasma HIV RNA levels 500 copiesml at or after week 16 or who have relapsed may register to Step 2 treatment addition of at least 2 new drugs to their prior treatment regimen enroll in another ACTG protocol at time of failure or seek the best available therapy while continuing to be followed for remainder of study
This is a Phase II randomized controlled open-label trial of NFV SQVsgc and either DLV or combined 3TCZDV versus NFV and combined 3TCZDV Prior to randomization patients are stratified by HIV RNA above or below 65000 copiesml and by prior antiretroviral therapy no therapy vs any therapy Patients 100 patientsarm are then randomly assigned to one of four arms Arm I receives NFV plus combination 3TCZDV Arm II receives NFV plus SQVsgc plus combination 3TCZDV Arm III receives NFV plus SQVsgc plus DLV Arm IV receives NFV plus SQVsgc plus DLV Treatment continues for 48 weeks following enrollment of the last patient Response to treatment is assessed at week 16 Patients with confirmed plasma HIV RNA levels 500 copiesml at week 16 whose plasma HIV RNA has decreased since study entry day 0 may continue therapy and be reassessed at weeks 20 and 24 Patients considered treatment failures ie 2 consecutive plasma HIV RNA levels 500 copiesml at or after week 16 or who have relapsed may register to Step 2 treatment addition of at least 2 new drugs to their prior treatment regimen enroll in another ACTG protocol at time of failure or seek the best available therapy while continuing to be followed for remainder of study
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?: