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

July 17, 2012
July 31, 2012
July 2011
February 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01656109 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Atazavanir/Ritonavir-based HAART in Children
The Study of Atazavanir/Ritonavir-based HAART in Thai HIV-infected Children

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
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-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
    Intervention: Drug: boosted atazanavir (ATV/r)
  • Experimental: PI-naïve group
    Never been exposed to any PI-containing regimen HIV-RNA viral load ≥ 1,000 copies/ml at the screening visit
    Intervention: Drug: boosted atazanavir (ATV/r)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
6 Years to 18 Years
No
Contact: Torsak Bunupuradah, MD 662-652-3040 torsak.b@hivnat.org
Thailand
 
NCT01656109
HIV-NAT 146
No
The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
  • amfAR and Treat Asia
  • Thai National Health Security Office (NHSO)
  • The Thai Government Pharmaceutical Organization (GPO)
Principal Investigator: Torsak Bunupuradah, MD The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP