Comparison of Treatment Failure Criteria in HIV-Infected Children in Uganda
Optimizing Antiretroviral Treatment Switch in HIV-Infected Ugandan Children
1 other identifier
interventional
133
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started May 2013
Typical duration for not_applicable hiv
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2017
CompletedFirst Submitted
Initial submission to the registry
July 13, 2020
CompletedFirst Posted
Study publicly available on registry
July 28, 2020
CompletedJuly 28, 2020
July 1, 2020
3.7 years
July 13, 2020
July 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Criteria for switching HIV-Infected Children to second line
Confirmed viral load \> 1,000 HIV RNA copies/ml
2 years
Study Arms (2)
Clinical and Immunologic criteria
ACTIVE COMPARATORIn 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.
Clinical, Immunologic and Virologic criteria
ACTIVE COMPARATORIn 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MU-JHU CARElead
Related Publications (1)
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.
PMID: 33752636DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2020
First Posted
July 28, 2020
Study Start
May 1, 2013
Primary Completion
January 16, 2017
Study Completion
January 16, 2017
Last Updated
July 28, 2020
Record last verified: 2020-07