Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162682
Status:
COMPLETED
Last Update Posted:
2012-01-06
First Post:
2005-09-07
Brief Title:
Monitoring Highly Active Antiretroviral Therapy in HIV-infected Parents in Thailand
Sponsor:
Institut de Recherche pour le Developpement
Organization:
Institut de Recherche pour le Developpement
Study Overview
Official Title:
A Phase III Randomized Non-inferiority Trial Comparing the Standard Viral Load Based Antiretroviral Monitoring Strategy With a CD4 Based Monitoring Strategy Among Antiretroviral Naive Immunocompromised Adults in Thailand
Status:
COMPLETED
Status Verified Date:
2012-01
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:
The purpose of this study is to determine if a decision to switch to a subsequent antiretroviral regimen based upon the CD4 cell count rather than the standard switching strategy based on viral load could ensure the same immunological and clinical outcome and preserve future treatment options in AIDS patients
Detailed Description:
Implementation of highly active antiretroviral therapy HAART has led to a substantial decrease in HIV-related mortality and morbidity Current guidelines emphasize maximal and durable viral load suppression However while the goal of therapy is the restoration of immunity treatment failure is usually defined as the inability to maintain undetectable viral load without regard to immune function This situation often leads to a rapid sequence of therapeutic switches thus narrowing therapeutic options over time A monitoring strategy driven primarily by the patients immune restoration would most likely be as effective in preventing disease progression would lead to fewer changes in HAART regimens and would be considerably simpler and cost effective
Subjects will be randomly assigned to one of two switching strategies
VL-S the standard viral load VL based monitoring strategy where switching is performed when VL is confirmed within one month above 400 copies per mL
CD4-S the alternative CD4 based monitoring strategy where switching is performed when a confirmed within one month relative decline in CD4 count of more than 30 from peak values is observed within 200 cells from baseline
The initial HAART regimen will be a NNRTINRTI containing regimen and the second line regimen will be a PI containing regimen subsequent regimens will be chosen individually based on tolerance previous drugs used resistance profile and drugs available Patients will be followed until the end of the study maximum of 5 years for the first enrollee three years for the last enrollee
Subjects will be randomly assigned to one of two switching strategies
VL-S the standard viral load VL based monitoring strategy where switching is performed when VL is confirmed within one month above 400 copies per mL
CD4-S the alternative CD4 based monitoring strategy where switching is performed when a confirmed within one month relative decline in CD4 count of more than 30 from peak values is observed within 200 cells from baseline
The initial HAART regimen will be a NNRTINRTI containing regimen and the second line regimen will be a PI containing regimen subsequent regimens will be chosen individually based on tolerance previous drugs used resistance profile and drugs available Patients will be followed until the end of the study maximum of 5 years for the first enrollee three years for the last enrollee
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