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| Name | Class |
|---|---|
| Ministry of Education, Thailand | OTHER |
| National Health Security Office, Thailand | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| third line naive | Children on second line or other regimen who switch or start third line regimen |
| |
| third line experienced | children who are on third line regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| undetectable viral load | Primary endpoint will be the proportions of subjects with HIV RNA below 400 and 50 copies/ml at 48 weeks. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperlipidemia | Number of subjects with hyperlipidemia as a measure of safety | 48 weeks |
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Inclusion Criteria:
Children (< 18 years old) with HIV infection may enroll if one of the following criteria is met:
Exclusion Criteria:
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Thai children aged < 18 years old who are on or are switching to third line antiretroviral therapy
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| Name | Affiliation | Role |
|---|---|---|
| Thanyawee Puthanakit, MD | Chulalongkorn University | Principal Investigator |
| Kulkanya Chokephaibulkit, MD | Siriraj Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prapokklao Chantaburi | Chanthaburi | Changwat Chanthaburi | 22000 | Thailand | ||
| Chulalongkorn University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22954687 | Result | Chokephaibulkit K, Prasitsuebsai W, Wittawatmongkol O, Gorowara M, Phongsamart W, Sophonphan J, Kerr SJ, Vanprapar N, Puthanakit T, Pasomsap C, Suwanlerk T, Sekar V, Burger D, Ananworanich J; HIV-NAT 113 Pharmacokinetic Study Group. Pharmacokinetics of darunavir/ritonavir in Asian HIV-1-infected children aged >/=7 years. Antivir Ther. 2012;17(7):1263-9. doi: 10.3851/IMP2347. Epub 2012 Sep 6. |
| Label | URL |
|---|---|
| The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) | View source |
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Plasma and PBMC
| Bangkok |
| 10330 |
| Thailand |
| HIV-NAT | Bangkok | 10330 | Thailand |
| Siriraj Hospital, Mahidol University | Bangkok | 10700 | Thailand |
| Nakornping Hospital | Chiang Mai | 50180 | Thailand |
| Chiang Rai Regional Hospital | Chiang Rai | 57000 | Thailand |
| Khon Kaen University | Khon Kaen | 40002 | Thailand |
| Bamrasnaradura Institute | Nonthaburi | 11000 | Thailand |
| Surin Hospital | Surin | 32000 | Thailand |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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