Atazavanir/Ritonavir-based HAART in Children

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01656109

First Posted: August 2, 2012

Last Update Posted: August 26, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

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

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Atazanavir Atazanavir sulfate

U.S. FDA Resources

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

Information from the National Library of Medicine

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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

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): 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:

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) This link exits the ClinicalTrials.gov site

Publications:

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.


Responsible Party:	The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:	NCT01656109 History of Changes
Other Study ID Numbers:	HIV-NAT 146
First Submitted:	July 17, 2012
First Posted:	August 2, 2012
Last Update Posted:	August 26, 2014
Last Verified:	August 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

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