Treatment Failure of Second-line ART in Asian HIV-infected ChildrenTASER-PNCT01788891
Second-line Therapy
An observational study of Treatment Failure of Second-line ART in Asian HIV-infected Children, run by The HIV Netherlands Australia Thailand Research Collaboration at 8 sites in 4 countries.
Trial summary
This study will help identify which ARV candidates should be prioritized for pediatric use in resource-limited settings Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Treatment Failure of Second-line ART in Asian HIV-infected Children
- How many people
- 300 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Jan 2011to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Thailand4 sites
HIV-NAT
Bangkok, 10330
Siriraj Hospital
Bangkok, 10700
Research Institute for Health Sciences
Chiang Mai, Chiang Mai, 50200
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
Vietnam2 sites
Children's Hospital Number 1
Ho Chi Minh City
Children's Hospital Number 2
Ho Chi Minh City
About this study
Official title: TASER-Pediatrics: Prospective Monitoring of Second-line Antiretroviral Therapy Failure and Resistance in Children
This study will help identify which ARV candidates should be prioritized for pediatric use in resource-limited settings
Read the 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.
- Keywords
- longitudinal observational cohort study, multicenter, pediatrics, Asian, treatment failure, renal status, toxicities, therapeutic drug monitoring (TDM), drug levels in blood and hair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
resistance
To monitor for resistance development and resistance patterns in children failing second-line ART over 72 weeks
Measured: week 72
Secondary outcomes (3)
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
Measured: week 72
drug resistance
To assess HIV drug resistance patterns by virtual phenotyping
Measured: week 72
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
Measured: week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJan 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Failure of Second-line ART in Asian HIV-infected ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research, 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, Number 2 Children's Hospital, Ho Chi Minh City, Kirby Institute, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Nia Kurniati, MD, Principal investigator, Dr Cipto Mangunkusumo General HospitalKamarul Razali, MD, Principal investigator, Kuala Lumpur General HospitalTavitiya Sudjaritruk, MD, Principal investigator, Research Institute for Health Sciences, Chiang Mai UniversityPope Kosalaraksa, MD, Principal investigator, Srinagarind Hospital, Khon Kaen HospitalKulkanya Chokephaibulkit, MD, Principal investigator, Siriraj HospitalTruong Huu Khanh, MD, Principal investigator, Children's Hospital Number 1Do Chau Viet, MD, Principal investigator, Children's Hospital Number 2Jintanat Ananworanich, MD, PhD, Principal investigator, The HIV Netherlands Australia Thailand Research Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788891
- Sponsor's protocol ID
- HIV-NAT 149
- Acronym
- TASER-P
- Status last verified
- May 2016
- First submitted
- 7 Feb 2013
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TASER-Pediatrics: Prospective Monitoring of Second-line Antiretroviral Therapy Failure and Resistance in Children
- ClinicalTrials.gov ID
- NCT01788891
- Acronym / sponsor ID
- TASER-P / HIV-NAT 149
- Keywords
- longitudinal observational cohort study, multicenter, pediatrics, Asian, treatment failure, renal status, toxicities, therapeutic drug monitoring (TDM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research, 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, Number 2 Children's Hospital, Ho Chi Minh City, Kirby Institute, University of California, San Francisco
- Study start
- Jan 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will help identify which ARV candidates should be prioritized for pediatric use in resource-limited settings
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
resistance
Time frame: week 72
To monitor for resistance development and resistance patterns in children failing second-line ART over 72 weeks
3 secondary outcomes
virologic failure
Time frame: week 72
drug resistance
Time frame: week 72
ARV drug levels
Time frame: week 72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'s websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nia Kurniati, MD principal investigator
Dr Cipto Mangunkusumo General Hospital
Kamarul Razali, MD principal investigator
Kuala Lumpur General Hospital
Tavitiya Sudjaritruk, MD principal investigator
Research Institute for Health Sciences, Chiang Mai University
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Failure of Second-line ART in Asian HIV-infected Children, run by The HIV Netherlands Australia Thailand Research Collaboration at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Thailand, Vietnam, Indonesia, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resistance (time frame: week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.