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Atazavanir/Ritonavir-based HAART in Children

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ClinicalTrials.gov Identifier: NCT01656109
Recruitment Status : Completed
First Posted : August 2, 2012
Last Update Posted : August 26, 2014
Sponsor:
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

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Drug: boosted atazanavir (ATV/r) Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : July 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. CD4 [ Time Frame: 48 weeks ]
    Assess CD percent and count at week 48

  2. plasma viral load (HIV RNA) [ Time Frame: 48 weeks ]
    assess HIV RNA at week 24 and 48

  3. hyperbilirubin [ Time Frame: 48 weeks ]
    evaluate total and direct bilirubin at weeks 24 and 48


Eligibility Criteria
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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:

  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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Publications of Results:

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01656109     History of Changes
Other Study ID Numbers: HIV-NAT 146
First Posted: August 2, 2012    Key Record Dates
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