- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04489953
Comparison of Treatment Failure Criteria in HIV-Infected Children in Uganda
Optimizing Antiretroviral Treatment Switch in HIV-Infected Ugandan Children
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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
|
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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