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

HIV Clinical Trial

Official title:

Optimizing Antiretroviral Treatment Switch in HIV-Infected Ugandan Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04489953
• Other study ID #: 9415
• Status: Completed
• Phase: N/A
• Start date: May 1, 2013
• Est. completion date: January 16, 2017

Study information

• Verified date: July 2020
• Source: MU-JHU CARE
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: January 16, 2017
• Est. primary completion date: January 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MU-JHU CARE

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Criteria for switching HIV-Infected Children to second line	Confirmed viral load > 1,000 HIV RNA copies/ml	2 years