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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by The HIV Netherlands Australia Thailand Research Collaboration.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Chulalongkorn University
UMC St. Radboud, Nijmegen, The Netherlands
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01139905
First received: June 4, 2010
Last updated: February 3, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
HIV-1 Infection
Other: lopinavir/ritonavir
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pharmacokinetics of Low- Dose Lopinavir/Ritonavir Tablet Formulation HIV-1 Infected Children

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    study drug Aluvia (lopinavir/ritonavir 100/25 mg)


Estimated Enrollment: 24
Study Start Date: April 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01139905

Contacts
Contact: Thanyawee Puthanakit, MD 089-6658846 thanyawee.p@hivnat.org
Contact: Arune Klinklom, MD 083-6903757 tookitim@hotmail.com

Locations
Thailand
HIV-NAT Recruiting
Bangkok, Thailand, 10330
Contact: Thanyawee Puthanakit, MD    089-6658846    thanyawee.p@hivnat.org   
Contact: Arune Klinklom, MD    083-6903757    tookitim@hotmail.com   
Principal Investigator: Thanyawee Puthanakit, MD         
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Chulalongkorn University
UMC St. Radboud, Nijmegen, The Netherlands
Investigators
Principal Investigator: Kiat Ruxrungtham, MD The HIV Netherlands Australia Thailand Research Collaboration
  More Information

Additional Information:
No publications provided

Responsible Party: Kiat Ruxrungtham, HIV-NAT
ClinicalTrials.gov Identifier: NCT01139905     History of Changes
Other Study ID Numbers: HIV-NAT 100
Study First Received: June 4, 2010
Last Updated: February 3, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
Lopinavir/ritonavir
pharmacokinetic
low dose
HIV-infected children
pharmacokinetics of low-dose lopinavir/ritonavir in HIV-1 infected Thai children.

Additional relevant MeSH terms:
Lopinavir
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014