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Atazavanir/Ritonavir-based HAART in Children
This study has been completed.
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators:
amfAR, The Foundation for AIDS Research
National Health Security Office, Thailand
The Thai Government Pharmaceutical Organization (GPO)
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01656109
First received: July 17, 2012
Last updated: August 25, 2014
Last verified: August 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| HIV | Drug: boosted atazanavir (ATV/r) | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | The Study of Atazavanir/Ritonavir-based HAART in Thai HIV-infected Children |
Resource links provided by NLM:
Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:
Primary Outcome Measures:
- pharmacokinetics of atazanavir/ritonavir (ATV/r) [ Time Frame: 48 weeks ]Ctrough and Area under the curve (AUC) of atazanavir (ATV) and ritonavir (RTV) will be assessed
Secondary Outcome Measures:
- CD4 [ Time Frame: 48 weeks ]Assess CD percent and count at week 48
- plasma viral load (HIV RNA) [ Time Frame: 48 weeks ]assess HIV RNA at week 24 and 48
- hyperbilirubin [ Time Frame: 48 weeks ]evaluate total and direct bilirubin at weeks 24 and 48
| Enrollment: | 20 |
| Study Start Date: | July 2011 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PI-experience group
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
|
Drug: boosted atazanavir (ATV/r)
ATV/r will be taken orally once daily with food plus standard dose of 2 NRTIs according to Thai National HIV treatment guideline
|
|
Experimental: PI-naïve group
Never been exposed to any PI-containing regimen HIV-RNA viral load ≥ 1,000 copies/ml at the screening visit
|
Drug: boosted atazanavir (ATV/r)
ATV/r will be taken orally once daily with food plus standard dose of 2 NRTIs according to Thai National HIV treatment guideline
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV-infected children
- Age from 6- 18 years old
- Body weight ≥ 25 kg at screening visit
- ARV history, the children can be categorized in one of these 2 groups
- ALT <200 IU/L at screening visit
- Total bilirubin < 3 mg/dL at the screening visit
- Can swallow capsule
- Written informed consent from caregivers and assent (from children aged 7-17 years who know their HIV status)
Exclusion Criteria:
- Active opportunistic infection
- Relevant history or current condition, illness that might interfere with atazanavir/ritonavir absorption, distribution, metabolism or excretion.
- Use of concomitant medication that may interfere with the pharmacokinetics of ATV/r (i.e. efavirenz, indinavir, proton pump inhibitor, antacids, cisapride, clarithromycin, rifampin etc.)
- Pregnancy or lactating at screening visit
- Liver diseases e.g. hepatitis B carrier, chronic hepatitis, cirrhosis
- Inability to understand the nature and extent of the study and the procedures required.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656109
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656109
Locations
| Thailand | |
| Department of Pediatrics Faculty of Medicine, Chulalongkorn University | |
| Bangkok, Thailand, 10330 | |
| The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) | |
| Bangkok, Thailand, 10330 | |
| Division of Infectious Diseases Department of Pediatrics Faculty of Medicine, Ramathibodi Hospital, Mahidol University | |
| Bangkok, Thailand | |
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
amfAR, The Foundation for AIDS Research
National Health Security Office, Thailand
The Thai Government Pharmaceutical Organization (GPO)
Investigators
| Principal Investigator: | Torsak Bunupuradah, MD | The HIV Netherlands Australia Thailand Research Collaboration |
More Information
Additional Information:
Publications:
| Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
| ClinicalTrials.gov Identifier: | NCT01656109 History of Changes |
| Other Study ID Numbers: |
HIV-NAT 146 |
| Study First Received: | July 17, 2012 |
| Last Updated: | August 25, 2014 |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
|
pharmacokinetics atazanavir/ritonavir HIV-infected children |
Additional relevant MeSH terms:
|
Ritonavir Atazanavir Sulfate HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |
ClinicalTrials.gov processed this record on August 18, 2017