Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children

March 24, 2015 updated by: The HIV Netherlands Australia Thailand Research Collaboration

Pharmacokinetics of Low- Dose Lopinavir/Ritonavir Tablet Formulation HIV-1 Infected Children

To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, single arm study to compare standard dose with a new tablet formulation of a lower dose of lopinavir/ritonavir in HIV-1 infected children.

Study Type

Interventional

Enrollment (Actual)

24

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
        • HIV-NAT

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

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. HIV infection
  2. Age < 18 years old
  3. BW > 25 kg
  4. HIV RNA viral load < 50 copies within 6 months
  5. Written informed consent

Exclusion Criteria:

  1. Active opportunistic infection
  2. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
  3. Use of concomitant medications that may interfere with the pharmacokinetics of lopinavir/ritonavir

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour
Other: lopinavir/ritonavir
standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%)
Time Frame: 4 months
study drug Aluvia (lopinavir/ritonavir 100/25 mg)
4 months

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

Chulalongkorn University
UMC St. Radboud, Nijmegen, The Netherlands

Investigators

  • Principal Investigator: Kiat Ruxrungtham, 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

April 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

June 4, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIV-NAT 100

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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