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

June 4, 2010
February 3, 2011
April 2010
August 2010   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01139905 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children
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.

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.

Interventional
Phase 2
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
HIV-1 Infection
Other: lopinavir/ritonavir
standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour.
1
standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour
Intervention: Other: lopinavir/ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
March 2011
August 2010   (final data collection date for primary outcome measure)

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
Both
1 Year to 18 Years
No
Contact: Thanyawee Puthanakit, MD 089-6658846 thanyawee.p@hivnat.org
Contact: Arune Klinklom, MD 083-6903757 tookitim@hotmail.com
Thailand
 
NCT01139905
HIV-NAT 100
No
Kiat Ruxrungtham, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
  • Chulalongkorn University
  • UMC St. Radboud, Nijmegen, The Netherlands
Principal Investigator: Kiat Ruxrungtham, MD The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP