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Completed

NCT Number: NCT01656109

Atazavanir/Ritonavir-based HAART in 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.

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Key information

Conditions

HIV

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Pediatrics Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

boosted atazanavir (ATV/r)

Drug

ATV/r will be taken orally once daily with food plus standard dose of 2 NRTIs according to Thai National HIV treatment guideline

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • National Health Security Office, Thailand
  • The Thai Government Pharmaceutical Organization (GPO)
  • amfAR, The Foundation for AIDS Research

Registry information

Official study title

The Study of Atazavanir/Ritonavir-based HAART in Thai HIV-infected Children

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 2, 2012
Registry last updated
Aug 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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