Second-line Therapy (TASER-P)
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Purpose
This study will help identify which ARV candidates should be prioritized for pediatric use in resource-limited settings
| Condition |
|---|
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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 |
- 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
- 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 |
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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
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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 |
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.
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| 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 | |
| Principal Investigator: | Nia Kurniati, MD | 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 March 10, 2013
