NCT01788891

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
4 countries

8 active sites

Status
completed

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

January 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

4.5 years

First QC Date

February 7, 2013

Last Update Submit

May 9, 2016

Conditions

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

Keywords

longitudinal observational cohort studymulticenterpediatricsAsiantreatment failurerenal statustoxicitiestherapeutic drug monitoring (TDM)drug levels in blood and hair

Outcome Measures

Primary Outcomes (1)

  • resistance

    To monitor for resistance development and resistance patterns in children failing second-line ART over 72 weeks

    week 72

Secondary Outcomes (3)

  • virologic failure

    week 72

  • drug resistance

    week 72

  • ARV drug levels

    week 72

Study Arms (1)

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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

HIV-positive children \<18 years old who are have switched to or treated with second-line ART at one of the participating TREAT Asia Pediatric HIV Observational Database (TApHOD) sites.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Mangunkusumo General Hospital

Jakarta, 10430, Indonesia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Research Institute for Health Sciences

Chiang Mai, Chiang Mai, 50200, Thailand

Location

HIV-NAT

Bangkok, 10330, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Children's Hospital Number 1

Ho Chi Minh City, Vietnam

Location

Children's Hospital Number 2

Ho Chi Minh City, Vietnam

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and hair will be used for therapeutic drug monitoring (TDM). Blood drawn at every visit will be used to assess CD4 count, viral load, and other basic chemistry test panel. If necessary, drug resistant tests will also be carried out on the blood samples.

Study Officials

  • Nia Kurniati, MD

    Dr Cipto Mangunkusumo General Hospital

    PRINCIPAL INVESTIGATOR

  • Kamarul Razali, MD

    Kuala Lumpur General Hospital

    PRINCIPAL INVESTIGATOR

  • Tavitiya Sudjaritruk, MD

    Research Institute for Health Sciences, Chiang Mai University

    PRINCIPAL INVESTIGATOR

  • Pope Kosalaraksa, MD

    Srinagarind Hospital, Khon Kaen Hospital

    PRINCIPAL INVESTIGATOR

  • Kulkanya Chokephaibulkit, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

  • Truong Huu Khanh, MD

    Children's Hospital Number 1

    PRINCIPAL INVESTIGATOR

  • Do Chau Viet, MD

    Children's Hospital Number 2

    PRINCIPAL INVESTIGATOR

  • Jintanat Ananworanich, MD, PhD

    The HIV Netherlands Australia Thailand Research Collaboration

    PRINCIPAL INVESTIGATOR

  • Annette Sohn, MD

    TREAT Asia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

January 1, 2011

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations

TH(4)ID(1)MY(1)VN(2)