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| Name | Class |
|---|---|
| amfAR, The Foundation for AIDS Research | OTHER |
| National Health Security Office, Thailand | OTHER |
| The Thai Government Pharmaceutical Organization (GPO) | UNKNOWN |
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There are no data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected Asian children. Therefore, the investigators aim to evaluate the pharmacokinetics, efficacy and safety of ATV/r-based HAART in Thai HIV-infected children.
Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based HAART have been commonly prescribed as the first-line HAART for HIV-infected children in resource-limited settings. Protease inhibitor (PI)-based HAART are the recommended second-line regimen after failing NNRTI-based HAART. The most commonly used PI in Thailand is lopinavir/ritonavir (LPV/r). However, the metabolic complications of lopinavir/ritonaive (LPV/r) such as hyperlipidemia and lipodyrtrophy are common and a concern for HIV-infected children as it may contribute to the development of cardiovascular disease in the longer term. There are data on efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected adults but none in children. Furthermore, many studies in both adults and children have shown that different ethnicities can result in different pharmacokinetic response to antiretroviral drugs. As a result of this, this study investigated the efficacy, safety and pharmacokinetics of ATV/r-based HAART in HIV-infected Asian children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PI-experience group | Experimental | Using PI-based HAART for ≥6 months at the screening visit HIV-RNA viral load < 50 copies/ml at the screening visit No history of HIV-RNA ≥ 1,000 copies/ml while using PI-based HAART |
|
| PI-naïve group | Experimental | Never been exposed to any PI-containing regimen HIV-RNA viral load ≥ 1,000 copies/ml at the screening visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| boosted atazanavir (ATV/r) | Drug | ATV/r will be taken orally once daily with food plus standard dose of 2 NRTIs according to Thai National HIV treatment guideline |
|
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics of atazanavir/ritonavir (ATV/r) | Ctrough and Area under the curve (AUC) of atazanavir (ATV) and ritonavir (RTV) will be assessed | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CD4 | Assess CD percent and count at week 48 | 48 weeks |
| plasma viral load (HIV RNA) | assess HIV RNA at week 24 and 48 | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torsak Bunupuradah, MD | The HIV Netherlands Australia Thailand Research Collaboration | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics Faculty of Medicine, Chulalongkorn University | Bangkok | 10330 | Thailand | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24983717 | Result | Bunupuradah T, Techasaensiri C, Keadpudsa S, Thammajaruk N, Srimuan A, Sahakijpicharn T, Prasitsuebsai W, Ananworanich J, Puthanakit T; HIV-NAT 146 Study Team. Pharmacokinetics of atazanavir/ritonavir among HIV-infected Thai children concomitantly taking tenofovir disoproxil fumarate. Pediatr Infect Dis J. 2014 Dec;33(12):e316-9. doi: 10.1097/INF.0000000000000469. |
| Label | URL |
|---|---|
| HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) | View source |
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| hyperbilirubin | evaluate total and direct bilirubin at weeks 24 and 48 | 48 weeks |
| The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) |
| Bangkok |
| 10330 |
| Thailand |
| Division of Infectious Diseases Department of Pediatrics Faculty of Medicine, Ramathibodi Hospital, Mahidol University | Bangkok | Thailand |