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

July 27, 2020 updated by: MU-JHU CARE

Optimizing Antiretroviral Treatment Switch in HIV-Infected Ugandan Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

133

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Criteria for switching HIV-Infected Children to second line
Time Frame: 2 years
Confirmed viral load > 1,000 HIV RNA copies/ml
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MU-JHU CARE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

January 16, 2017

Study Completion (Actual)

January 16, 2017

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 9415

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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