Atazavanir/Ritonavir-based HAART in Children

This study has been completed.
Sponsor:
Collaborators:
amfAR and Treat Asia
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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656109

Locations
Thailand
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
Department of Pediatrics Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
amfAR and Treat Asia
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
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 September 22, 2014