Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120783
Status:
TERMINATED
Last Update Posted:
2007-01-18
First Post:
2005-07-12
Brief Title:
Efficacy and Tolerability of an Antiretroviral Bi-Therapy in HIV Infected Patients With Multidrug Resistance
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Efficacy and Tolerability of an Antiretroviral bi-Therapy in HIV-1 Infected Patients With Multidrug Resistant HIV ANRS 109 Vista Trial
Status:
TERMINATED
Status Verified Date:
2007-01
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 investigated whether a calibrated reduction in antiretroviral drug pressures could stabilize the evolution and the pathogenic potential of resistant HIV viruses
Detailed Description:
In patients with HIV multidrug resistance maintaining a failing full-dose HAART regimen usually results in significant drug toxicity and in continued accumulation of resistance mutations that can preclude future therapeutic options In contrast treatment interruption provokes the reemergence of wild-type virus with full replicative and pathogenic capacity The researchers investigated whether a calibrated reduction in drug pressure could stabilize the evolution and the pathogenic potential of resistant virus
A prospective pilot study was conducted in patients receiving protease inhibitor-based HAART with a resistance genotype predicting less than two active drugs according to the 2002 ANRS algorithm CD4 counts over or equal to 100mm3 and plasma HIV RNA below or equal to 5 logml The treatment was low-dose IDVRTV 200100 BID and 3TC 150mg BID IDV doses were adjusted at week 4 to ensure a Cmin of 250-100ngml which based on a panel of multi-PI resistant viruses was calculated to yield an inhibitory quotient CminIC50 of 050 Primary end-points were over 25 decrease in CD4 counts immunological failure-IF or over 07 log increase in plasma HIV RNA virological failure-VF at two consecutive monthly visits during the 24-week study Inclusions were to stop when the total number of failures VFIF reached 7
A prospective pilot study was conducted in patients receiving protease inhibitor-based HAART with a resistance genotype predicting less than two active drugs according to the 2002 ANRS algorithm CD4 counts over or equal to 100mm3 and plasma HIV RNA below or equal to 5 logml The treatment was low-dose IDVRTV 200100 BID and 3TC 150mg BID IDV doses were adjusted at week 4 to ensure a Cmin of 250-100ngml which based on a panel of multi-PI resistant viruses was calculated to yield an inhibitory quotient CminIC50 of 050 Primary end-points were over 25 decrease in CD4 counts immunological failure-IF or over 07 log increase in plasma HIV RNA virological failure-VF at two consecutive monthly visits during the 24-week study Inclusions were to stop when the total number of failures VFIF reached 7
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