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OpenTrials
Completed

NCT Number: NCT04489953

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

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.

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Key information

Conditions

HIV

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Viral Load

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

Primary outcomes

  1. Criteria for switching HIV-Infected Children to second line

    Time frame: 2 years

    Confirmed viral load > 1,000 HIV RNA copies/ml

Sponsors and collaborators

Lead sponsor

MU-JHU CARE

Other

Registry information

Official study title

Optimizing Antiretroviral Treatment Switch in HIV-Infected Ugandan Children

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 28, 2020
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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