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Comparison of Treatment Failure Criteria in HIV-Infected Children in Uganda

HIV Clinical Trial

Official title:
Optimizing Antiretroviral Treatment Switch in HIV-Infected Ugandan Children

Clinical Trial Summary

The main goal was to compare clinical and immunological versus clinical, immunological plus viral load criteria for switching to second-line ART by comparing 48 week treatment outcomes, including survival rates, viral suppression, failure to thrive, and AIDS-defining illnesses for treatment experienced children randomized to two switching criteria.

Clinical Trial Description

The overall goal of the study was aimed at determining whether the use of the current WHO criteria alone (clinical and immunologic) to define treatment failure as the trigger for switching to second-line antiretroviral therapy leads to poorer 6 month and 12 month treatment outcomes when compared to combining clinical and immunologic parameters with viral load (VL) monitoring.

In addition the study aimed at obtaining plasma samples from treatment experienced children, for future resistance testing. The results of this study may help guide WHO and national pediatric ART programs on the need for routine VL monitoring for children initiating HAART in resource limited settings, where virologic tests including resistance testing are not readily available or affordable. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04489953
Study type Interventional
Source MU-JHU CARE
Contact
Status Completed
Phase N/A
Start date May 1, 2013
Completion date January 16, 2017
View Details
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