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

NCT ID: NCT04489953

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-01
• Study Completion Date: 2017-01-16

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinical and Immunologic 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.

Group Type: ACTIVE_COMPARATOR

Viral Load

Intervention Type: OTHER

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

Clinical, Immunologic and Virologic criteria

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

Group Type: ACTIVE_COMPARATOR

Viral Load

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MU-JHU CARE

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Kibalama Ssemambo P, Nalubega-Mboowa MG, Owora A, Serunjogi R, Kironde S, Nakabuye S, Ssozi F, Nannyonga M, Musoke P, Barlow-Mosha L. Virologic response of treatment experienced HIV-infected Ugandan children and adolescents on NNRTI based first-line regimen, previously monitored without viral load. BMC Pediatr. 2021 Mar 22;21(1):139. doi: 10.1186/s12887-021-02608-0.

Reference Type: DERIVED

PMID: 33752636 (View on PubMed)

Other Identifiers

9415

Identifier Type: -

Identifier Source: org_study_id