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

MU-JHU CARE

Status: Completed

Conditions: HIV

Treatments: Other: Viral Load

Study type: Interventional

Funder types: Other

Identifiers

NCT04489953

9415

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 2 patient groups

Clinical and Immunologic criteria

Active Comparator group

Description:

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.

Treatment:

Other: Viral Load

Clinical, Immunologic and Virologic criteria

Active Comparator group

Description:

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

Treatment:

Other: Viral Load