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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 ] [ Designated as safety issue: No ]Ctrough and Area under the curve (AUC) of atazanavir (ATV) and ritonavir (RTV) will be assessed
Secondary Outcome Measures:
- CD4 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]Assess CD percent and count at week 48
- plasma viral load (HIV RNA) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]assess HIV RNA at week 24 and 48
- hyperbilirubin [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]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) |
| Genders Eligible for Study: | Both |
| 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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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 |
| Health Authority: | Thailand: Ethical Committee |
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 September 27, 2016