Atazavanir/Ritonavir-based HAART in Children

This study is currently recruiting participants.
Verified July 2012 by The HIV Netherlands Australia Thailand Research Collaboration
Sponsor:
Collaborators:
amfAR and Treat Asia
Thai National Health Security Office (NHSO)
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: July 31, 2012
Last verified: July 2012
  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


Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: February 2013
Estimated 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-infected children
  2. Age from 6- 18 years old
  3. Body weight ≥ 25 kg at screening visit
  4. ARV history, the children can be categorized in one of these 2 groups
  5. ALT <200 IU/L at screening visit
  6. Total bilirubin < 3 mg/dL at the screening visit
  7. Can swallow capsule
  8. Written informed consent from caregivers and assent (from children aged 7-17 years who know their HIV status)

Exclusion Criteria:

  1. Active opportunistic infection
  2. Relevant history or current condition, illness that might interfere with atazanavir/ritonavir absorption, distribution, metabolism or excretion.
  3. 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.)
  4. Pregnancy or lactating at screening visit
  5. Liver diseases e.g. hepatitis B carrier, chronic hepatitis, cirrhosis
  6. Inability to understand the nature and extent of the study and the procedures required.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656109

Contacts
Contact: Torsak Bunupuradah, MD 662-652-3040 torsak.b@hivnat.org

Locations
Thailand
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) Recruiting
Bangkok, Thailand, 10330
Contact: Torsak Bunupuradah, MD    662-652-3040    torsak.b@hivnat.org   
Contact: Wasana Prasitsuebsai, MD    662-652-3040    wasana.p@hivnat.org   
Principal Investigator: Torsak Bunupuradah, MD         
Division of Infectious Diseases Department of Pediatrics Faculty of Medicine, Ramathibodi Hospital, Mahidol University Recruiting
Bangkok, Thailand
Contact: Chonnamet Techasaensiri, MD       chonmet@yahoo.com   
Principal Investigator: Chonnamet Techasaensiri, MD         
Department of Pediatrics Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Thanyawee Puthanakit, MD    662-652-3040    thanyawee.p@hivnat.org   
Principal Investigator: Thanyawee Puthanakit, MD         
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
amfAR and Treat Asia
Thai National Health Security Office (NHSO)
The Thai Government Pharmaceutical Organization (GPO)
Investigators
Principal Investigator: Torsak Bunupuradah, MD The HIV Netherlands Australia Thailand Research Collaboration
  More Information

Additional Information:
No publications provided

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: July 31, 2012
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
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014