Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children
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| ClinicalTrials.gov Identifier: NCT01225406 |
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Recruitment Status
:
Completed
First Posted
: October 21, 2010
Last Update Posted
: January 26, 2017
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Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators:
Ministry of Education, Thailand
National Health Security Office, Thailand
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
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Brief Summary:
This is an observational cohort study of virologic and immunologic outcome after at least 48 weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be enrolled. Third line antiretroviral therapy in this study is defined as an antiretroviral (ARV) regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir The knowledge gained from this study will help the Thai government in planning its strategy to provide third line ARV therapy to children within the national program.
| Condition or disease | Intervention/treatment |
|---|---|
| This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy | Drug: Tenofovir |
The primary objective of this study is to assess the virological efficacy, as measured by the proportions of children with HIV RNA below 400 and 50 copies/ml at 48 weeks after initiating third line ARV therapy.
Third line ARV therapy is defined as an ARV regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir
| Study Type : | Observational |
| Actual Enrollment : | 56 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Official Title: | Treatment Cohort of HIV-infected Children With Resistance or Intolerance to Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI) First Line and PI Second Line Antiretroviral Therapy |
| Study Start Date : | August 2010 |
| Actual Primary Completion Date : | August 2013 |
| Actual Study Completion Date : | December 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Tenofovir
U.S. FDA Resources
| Group/Cohort | Intervention/treatment |
|---|---|
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third line naive
Children on second line or other regimen who switch or start third line regimen
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Drug: Tenofovir |
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third line experienced
children who are on third line regimen
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Drug: Tenofovir |
Primary Outcome Measures
:
- undetectable viral load [ Time Frame: 48 weeks ]Primary endpoint will be the proportions of subjects with HIV RNA below 400 and 50 copies/ml at 48 weeks.
Secondary Outcome Measures
:
- Hyperlipidemia [ Time Frame: 48 weeks ]Number of subjects with hyperlipidemia as a measure of safety
Biospecimen Retention: Samples Without DNA
Plasma and PBMC
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| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Thai children aged < 18 years old who are on or are switching to third line antiretroviral therapy
Criteria
Inclusion Criteria:
Children (< 18 years old) with HIV infection may enroll if one of the following criteria is met:
- Have resistance to at least one drug in each of the 3 classes (NRTI, NNRTI and PI) and have plasma HIV RNA > 1000 copies/ml prior to switching to third line ARV therapy
- Have intolerance to the current NRTI, NNRTI or PI treatment and need to receive darunavir, etravirine, tipranavir or raltegravir
Exclusion Criteria:
- Have hepatic impairment with ALT ≥ 5 upper limit of normal
- Pregnant or breastfeeding
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225406
Locations
| Thailand | |
| Chulalongkorn University | |
| Bangkok, Thailand, 10330 | |
| HIV-NAT | |
| Bangkok, Thailand, 10330 | |
| Siriraj Hospital, Mahidol University | |
| Bangkok, Thailand, 10700 | |
| Prapokklao Chantaburi | |
| Chantaburi, Thailand, 22000 | |
| Nakornping Hospital | |
| Chiang Mai, Thailand, 50180 | |
| Chiang Rai Regional Hospital | |
| Chiang Rai, Thailand, 57000 | |
| Khon Kaen University | |
| Khon Kaen, Thailand, 40002 | |
| Bamrasnaradura Institute | |
| Nonthaburi, Thailand, 11000 | |
| Surin Hospital | |
| Surin, Thailand, 32000 | |
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Ministry of Education, Thailand
National Health Security Office, Thailand
Investigators
| Principal Investigator: | Thanyawee Puthanakit, MD | Chulalongkorn University, Bangkok | |
| Principal Investigator: | Kulkanya Chokephaibulkit, MD | Siriraj Hospital, Mahidol University, Bangkok, Thailand |
Additional Information:
Publications of Results:
| Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
| ClinicalTrials.gov Identifier: | NCT01225406 History of Changes |
| Other Study ID Numbers: |
HIV-NAT 113 |
| First Posted: | October 21, 2010 Key Record Dates |
| Last Update Posted: | January 26, 2017 |
| Last Verified: | January 2017 |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
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Third line ARV therapy HIV RNA Absolute CD4+ T cell count serious adverse events (SAEs) Drug resistance |
Additional relevant MeSH terms:
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Tenofovir Reverse Transcriptase Inhibitors Antiviral Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |