Atazavanir/Ritonavir-based HAART in Children

August 25, 2014 updated by: The HIV Netherlands Australia Thailand Research Collaboration

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)
      • Bangkok, Thailand, 10330
        • Department of Pediatrics Faculty of Medicine, Chulalongkorn University
      • Bangkok, Thailand
        • Division of Infectious Diseases Department of Pediatrics Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD4
Time Frame: 48 weeks
Assess CD percent and count at week 48
48 weeks
plasma viral load (HIV RNA)
Time Frame: 48 weeks
assess HIV RNA at week 24 and 48
48 weeks
hyperbilirubin
Time Frame: 48 weeks
evaluate total and direct bilirubin at weeks 24 and 48
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

July 31, 2012

First Posted (Estimate)

August 2, 2012

Study Record Updates

Last Update Posted (Estimate)

August 26, 2014

Last Update Submitted That Met QC Criteria

August 25, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIV-NAT 146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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