Second-line Therapy

Treatment Failure of Second-line ART in Asian HIV-infected Children Clinical Trial

— TASER-P  

Official title:

TASER-Pediatrics: Prospective Monitoring of Second-line Antiretroviral Therapy Failure and Resistance in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788891
• Other study ID #: HIV-NAT 149
• Status: Completed
• Phase: N/A
• First received: February 7, 2013
• Last updated: May 9, 2016
• Start date: January 2011
• Est. completion date: July 2015

Study information

• Verified date: May 2016
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial Summary

This study will help identify which ARV candidates should be prioritized for pediatric use in resource-limited settings

Description:

Children in resource-limited settings are increasing experiencing treatment failure, as defined by virologic, immunologic, and/or clinical criteria. There are few studies of HIV resistance mutations in children failing first line NNRTI therapy in resource limited settings. The emergence of treatment failure and drug resistance in children on ART emphasizes the urgency for developing evidence-based second-line and salvage treatment strategies. Pediatric treatment is complicated by a number of factors, including having fewer numbers of ARVs approved by drug safety agencies and the lack of pediatric formulations. This further shortens the list of available second-line ARVs as compared to adults.

Despite the growing number of children on second-line therapy worldwide, there are limited data on efficacy of second-line PI therapy in children after NRTI-NNRTI failure. There are currently no options for third-line/salvage regimens for children in resource-limited settings. New drugs and drug classes are approved for use in children by the US FDA but are not routinely available outside of high-income settings.

Also, there are no data on the resistance patterns of children failing second-line therapy in resource-limited settings to guide clinical management and ARV procurement. Clinicians need evidence-based guidelines for how to manage children with treatment failure, and access to the drugs necessary to construct potent and durable third-line regimens.

TASER-P is a longitudinal observational cohort study to monitor for treatment failure to second-line ART in Asian children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Age < 18 years old

• Have confirmed HIV infection

• Are being switched to or treated with second-line ART. Second-line ART is defined as the second regimen with a major antiretroviral class switch. For example, a switch from an NNRTI-based to a PI-based regimen or vice versa

• Caregivers give informed consent. Children will be asked to give assent if they know their HIV status and have reached the minimum age to give assent according to each site's institutional review board regulations

Exclusion Criteria:

• Started mono- or dual- therapy as the first ART therapy

• Failing first-line triple nucleoside reverse transcriptase inhibitor regimen

• Are being switched to or treated with second-line ART without failure of first-line therapy (i.e., for toxicity)

• Caregiver +/- child (if asked to give assent) refuses to participate in this study

• Have not been enrolled in TApHOD

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Treatment Failure of Second-line ART in Asian HIV-infected Children

Locations

Country	Name	City	State
Indonesia	Mangunkusumo General Hospital	Jakarta
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
Thailand	HIV-NAT	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Research Institute for Health Sciences	Chiang Mai
Thailand	Srinagarind Hospital, Khon Kaen University	Khon Kaen
Vietnam	Children's Hospital Number 1	Ho Chi Minh City
Vietnam	Children's Hospital Number 2	Ho Chi Minh City

Sponsors (11)

Lead Sponsor

Collaborator

The HIV Netherlands Australia Thailand Research Collaboration

amfAR, The Foundation for AIDS Research, Chiang Mai University, Children's Hospital Number 1, Ho Chi Minh City, Vietnam, Children's Hospital Number 2, Ho Chi Minh City, Vietnam, Dr Cipto Mangunkusumo General Hospital, Mahidol University, Pediatric Institute, Hospital Kuala Lumpur, Srinagarind Hospital, Khon Kaen University, The Kirby Institute for Infection and Immunity in Society, University of California, San Francisco

Countries where clinical trial is conducted

Indonesia,  Malaysia,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resistance	To monitor for resistance development and resistance patterns in children failing second-line ART over 72 weeks	week 72	Yes
Secondary	virologic failure	To determine the frequency of virologic suppression defined as HIV-RNA <400 copies/ml over 72 weeks To determine the frequency of virologic failure as HIV RNA =1000 copies/ml over 72 weeks To evaluate predictors of virologic failure	week 72	Yes
Secondary	drug resistance	To assess HIV drug resistance patterns by virtual phenotyping	week 72	Yes
Secondary	ARV drug levels	To correlate ARV drug levels between plasma and hair samples To correlate hair ARV levels with virologic responses and measures of adherence	week 72	Yes

External Links

•   HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'s website