Second-line Therapy (TASER-P)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
amfAR, Therapeutics Research, Education, and AIDS Training in Asia (TREAT Asia) through an unrestricted grant from ViiV Healthcare
Dr Cipto Mangunkusumo General Hospital
Pediatric Institute, Hospital Kuala Lumpur
Chiang Mai University
Srinagarind Hospital, Khon Kaen University
Mahidol University
Children's Hospital Number 1, Ho Chi Minh City, Vietnam
Children's Hospital Number 2, Ho Chi Minh City, Vietnam
The Kirby Institute for Infection and Immunity in Society
University of California, San Francisco
Information provided by (Responsible Party):
Jintanat Ananworanich, The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01788891
First received: February 7, 2013
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TASER-Pediatrics: Prospective Monitoring of Second-line Antiretroviral Therapy Failure and Resistance in Children

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • resistance [ Time Frame: week 72 ] [ Designated as safety issue: Yes ]
    To monitor for resistance development and resistance patterns in children failing second-line ART over 72 weeks


Secondary Outcome Measures:
  • virologic failure [ Time Frame: week 72 ] [ Designated as safety issue: Yes ]
    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

  • drug resistance [ Time Frame: week 72 ] [ Designated as safety issue: Yes ]
    To assess HIV drug resistance patterns by virtual phenotyping

  • ARV drug levels [ Time Frame: week 72 ] [ Designated as safety issue: Yes ]
    To correlate ARV drug levels between plasma and hair samples To correlate hair ARV levels with virologic responses and measures of adherence


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.


Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788891

Locations
Indonesia
Mangunkusumo General Hospital
Jakarta, Indonesia, 10430
Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 50586
Thailand
Siriraj Hospital
Bangkok, Thailand, 10700
HIV-NAT
Bangkok, Thailand, 10330
Research Institute for Health Sciences
Chiang Mai, Thailand, 50200
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Thailand, 40002
Vietnam
Children's Hospital Number 1
Ho Chi Minh City, Vietnam
Children's Hospital Number 2
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
amfAR, Therapeutics Research, Education, and AIDS Training in Asia (TREAT Asia) through an unrestricted grant from ViiV Healthcare
Dr Cipto Mangunkusumo General Hospital
Pediatric Institute, Hospital Kuala Lumpur
Chiang Mai University
Srinagarind Hospital, Khon Kaen University
Mahidol University
Children's Hospital Number 1, Ho Chi Minh City, Vietnam
Children's Hospital Number 2, Ho Chi Minh City, Vietnam
The Kirby Institute for Infection and Immunity in Society
University of California, San Francisco
Investigators
Principal Investigator: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Jintanat Ananworanich, Site Principle Investigator, The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01788891     History of Changes
Other Study ID Numbers: HIV-NAT 149
Study First Received: February 7, 2013
Last Updated: February 8, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
longitudinal observational cohort study
multicenter
pediatrics
Asian
treatment failure
renal status
toxicities
therapeutic drug monitoring (TDM)
drug levels in blood and hair

ClinicalTrials.gov processed this record on July 28, 2014