Ignite Creation Date:
2024-05-05 @ 9:37 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00929604
Status:
COMPLETED
Last Update Posted:
2014-10-09
First Post:
2009-06-25
Brief Title:
HIV Viral Load Monitoring in Resource-Poor Settings
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Effectiveness of HIV Viral Load Monitoring of Patient Outcome in Resource-Poor Settings
Status:
COMPLETED
Status Verified Date:
2014-10
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:
No randomized clinical trial to date has demonstrated a survival benefit of using regular HIV-1 ribonucleic acid RNA viral load VL testing to monitor patients responses to antiretroviral therapy ART for HIV infection The measurement of VL is recommended to monitor the response to ART in developed countries In resource-constrained settings the World Health Organization WHO does not recommend routine VL testing in part due to the cost and complex infrastructure needed for reliable results In these settings WHO has proposed the use of clinical and CD4 lymphocyte-based criteria to guide treatment decisions However multiple studies have demonstrated the poor performance of these criteria in sub-Saharan Africa and the frequent discordance between immunologic and virologic responses to ART
The use of routine viral load monitoring should be evaluated in resource-constrained settings The investigators hypothesize that routine viral load testing of patients on ART will improve patient survival decrease disease progression and development of drug resistance and will be feasible and cost-effective for resource-constrained settings
The use of routine viral load monitoring should be evaluated in resource-constrained settings The investigators hypothesize that routine viral load testing of patients on ART will improve patient survival decrease disease progression and development of drug resistance and will be feasible and cost-effective for resource-constrained settings
Detailed Description:
The study Effectiveness of HIV Viral Load Monitoring on Patient Outcome in Resource-Poor Settings is a dual-arm cluster randomized trial to evaluate the use of routine plasma HIV-1 VL monitoring to improve survival and decrease HIV disease progression in patients receiving ART The primary objective is to assess mortality at 36 months among ART naïve patients initiating therapy and receiving care at facilities with access to routine HIV VL testing at ART initiation at 3 months and at every 6 months thereafter compared to those initiating first regimens and receiving care at facilities according to our local standard of care which uses immunological ie CD4 lymphocyte count-basedand clinical criteria to diagnose treatment failure with discretionary VL testing when the two do not agree
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