Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2011-01-31
2015-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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second-line pediatric cohort
Asian HIV-positive children \<18 years old who are receiving HIV care at one of the participating TREAT Asia Pediatric HIV Observational Database (TApHOD) sites that have been identified for TASER-P participation will be monitored for treatment failure of second-line ART
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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amfAR, The Foundation for AIDS Research
OTHER
Dr Cipto Mangunkusumo General Hospital
OTHER
Pediatric Institute, Hospital Kuala Lumpur
UNKNOWN
Chiang Mai University
OTHER
Srinagarind Hospital, Khon Kaen University
OTHER
Mahidol University
OTHER
Children's Hospital Number 1, Ho Chi Minh City, Vietnam
OTHER
Number 2 Children's Hospital, Ho Chi Minh City
OTHER
Kirby Institute
OTHER_GOV
University of California, San Francisco
OTHER
The HIV Netherlands Australia Thailand Research Collaboration
OTHER
Responsible Party
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Principal Investigators
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Nia Kurniati, MD
Role: PRINCIPAL_INVESTIGATOR
Dr Cipto Mangunkusumo General Hospital
Kamarul Razali, MD
Role: PRINCIPAL_INVESTIGATOR
Kuala Lumpur General Hospital
Tavitiya Sudjaritruk, MD
Role: PRINCIPAL_INVESTIGATOR
Research Institute for Health Sciences, Chiang Mai University
Pope Kosalaraksa, MD
Role: PRINCIPAL_INVESTIGATOR
Srinagarind Hospital, Khon Kaen Hospital
Kulkanya Chokephaibulkit, MD
Role: PRINCIPAL_INVESTIGATOR
Siriraj Hospital
Truong Huu Khanh, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Number 1
Do Chau Viet, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Number 2
Jintanat Ananworanich, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The HIV Netherlands Australia Thailand Research Collaboration
Annette Sohn, MD
Role: PRINCIPAL_INVESTIGATOR
TREAT Asia
Locations
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Mangunkusumo General Hospital
Jakarta, , Indonesia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, Thailand
Research Institute for Health Sciences
Chiang Mai, Chiang Mai, Thailand
HIV-NAT
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Children's Hospital Number 1
Ho Chi Minh City, , Vietnam
Children's Hospital Number 2
Ho Chi Minh City, , Vietnam
Countries
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Related Links
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HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'s website
Other Identifiers
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HIV-NAT 149
Identifier Type: -
Identifier Source: org_study_id
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