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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Other: Viral Load

• Registration Number: NCT04489953
• Lead Sponsor: MU-JHU CARE

Brief 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.

Detailed 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 Timeline

• Study Start: 2013-05-01
• Primary Completion: 2017-01-16
• Study Completion: 2017-01-16
• Status Verified: 2020-07
• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-28
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• HIV-Infected Children, 1 year to 12 years
• ART experienced and enrolled in an existing treatment program that used clinical and immunologic criteria to monitor response to ART.

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinical, Immunologic and Virologic criteria	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
Clinical and Immunologic criteria	Viral Load	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.

Primary Outcome Measures

Name	Time	Method
Criteria for switching HIV-Infected Children to second line	2 years	Confirmed viral load \> 1,000 HIV RNA copies/ml