An interventional study of Viral Load in HIV, sponsored by MU-JHU CARE. Completed. Open to participants aged 1 Year to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-28.
Sponsored by MU-JHU CARE · Not applicable, Interventional, and Treatment
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.
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.
MU-JHU CARE is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the clinical and immunologic monitoring criteria was based on the 2010 WHO guidelines. Whereby children were monitored using clinical presentation and CD4 count to define treatment failure.
Other: Viral Load
In the Clinical, Immunologic and Virologic criteria was based on a confirmed viral load of \> 1000 HIV RNA copies/ml; as well as clinical and immunologic criteria
Other: Viral Load
For the Clinical and Immunologic criteria, viral load was done retrospectively on stored plasma samples. Whereas for the Clinical, Immunologic and Virologic criteria, viral load was done in real-time
Criteria for switching HIV-Infected Children to second line
Confirmed viral load \> 1,000 HIV RNA copies/ml
Time frame: 2 years
No study locations are listed for this record.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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MU-JHU CARE